Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0429-2026 | 03-11-2026 | 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02. Package NDCs: 17271-701-02; 17271-701-03; 17271-701-05; 17271-701-06; 17271-701-07 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0434-2026 | 03-11-2026 | 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07. Package NDCs: 17271-701-02; 17271-701-03; 17271-701-05; 17271-701-06; 17271-701-07 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0432-2026 | 03-11-2026 | 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85. Package NDCs: 65219-432-20; 65219-432-85; 65219-328-10; 65219-328-50 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0430-2026 | 03-11-2026 | 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03. Package NDCs: 17271-701-02; 17271-701-03; 17271-701-05; 17271-701-06; 17271-701-07 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0424-2026 | 03-11-2026 | 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case). Package NDCs: 63323-626-01; 63323-626-50; 63323-626-02; 63323-626-00; 63323-626-03; 63323-626-25; 63323-626-04; 63323-626-55; 63323-626-05; 63323-626-10 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0425-2026 | 03-11-2026 | 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60. Package NDCs: 65219-466-05; 65219-466-60; 65219-468-05; 65219-468-50; 65219-470-05; 65219-470-30; 65219-472-05; 65219-472-20; 65219-474-05; 65219-474-10 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0433-2026 | 03-11-2026 | 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10. Package NDCs: 65219-282-01; 65219-282-10 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0428-2026 | 03-11-2026 | 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20. Package NDCs: 65219-466-05; 65219-466-60; 65219-468-05; 65219-468-50; 65219-470-05; 65219-470-30; 65219-472-05; 65219-472-20; 65219-474-05; 65219-474-10 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0436-2026 | 03-11-2026 | 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50. Package NDCs: 65219-456-05; 65219-456-60; 65219-464-05; 65219-464-50; 65219-458-05; 65219-458-30; 65219-460-05; 65219-460-20; 65219-462-05; 65219-462-10 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0427-2026 | 03-11-2026 | 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30. Package NDCs: 65219-466-05; 65219-466-60; 65219-468-05; 65219-468-50; 65219-470-05; 65219-470-30; 65219-472-05; 65219-472-20; 65219-474-05; 65219-474-10 | Lack of Assurance of Sterility | Fresenius Kabi USA, LLC / | Class II | Ongoing |
| D-0400-2026 | 03-09-2026 | Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7 Package NDCs: 70710-1738-4; 70710-1592-7 | Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. | Zydus Pharmaceuticals (USA) Inc / 60,541 bottles | Class II | Ongoing |
| D-0471-2026 | 03-06-2026 | Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR | Lack of Assurance of Sterility | PAYLESS COMPOUNDERS, LLC / 91 vials | Class II | Ongoing |
| D-0407-2026 | 03-05-2026 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1. Package NDCs: 60505-0589-1; 60505-0589-2; 60505-0589-3 | Lack of Assurance of Sterility | Apotex Corp. / 107,136 vials | Class II | Ongoing |
| D-0411-2026 | 03-03-2026 | Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., Lakewood, NJ 08701, NDC 57896-181-05; b) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; c) Rite Aid, DISTRIBUTEDBY: RITE AID, Camp Hill, PA 17011, NDC 11822-1067-2; d) LEADER DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01156 6; f) H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Foster & Thrive, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1158-1; h) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-718-01; i) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; j) Harris Teeter, Eye Drops, Artificial Tears, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71303 2; k) exchange select, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; l) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-605-05 Package NDCs: 57896-181-05; 11822-1067-2; 70000-0502-1; 70000-0502-2; 70677-1158-1; 41250-718-01; 46122-605-05 | Lack of Assurance of Sterility | K.C. Pharmaceuticals, Inc / 1,023,096 bottles | Class II | Ongoing |
| D-0413-2026 | 03-03-2026 | Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-141-01; b) Walgreens, Eye Drops, Original Formula, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20073 6; c) Walgreens, Eye Drops, Original Formula, 2 Bottles, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20076 7; d) Kroger Sterile eye drops, Original, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 1110 38597 0; e) Sterile eye drops, Regular formula, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, UPC 3 66715 68324 3; f) CVP Sterile EYE DROPS, Distributed by: Salado Sales. Inc., Temple, TX 76503; UPC 7 61606 16500 3; g) Harris Teeter, Eye Drops, Original, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71302 5; h) H.E.B Original Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; i) Rugby tetrahydrozoline ophthalmic Solution, Distributed by: RUGBY LABORATORIES, IN 46268, NDC 0536-1217-94, j) Equaline, DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908, UPC 0 41163 25110 6; k) Discount drug mart, EyeDrops ORIGINAL, Discount Drug Mart Food Fair, 211 Commerce Drive, Medina, OH 44256, UPC 0 93351 01156 3; L) LEADER Original Eye Drops, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0454-1; m) CAREone, DISTRIBUTED BY FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 41520-431-05; n) Circle K sterile eye drops, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, Proudly distributed by Circle K Stores Inc., UPC 1 94283 65185 8; o) DG health Original Formula, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; p) Good Neighbor Pharmacy Eye Drops, Original Formula, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-075-05; q) TopCare health, Original Eye Drops, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; r) Best Choice, Eye Drops, ORIGINAL, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47011 3 Package NDCs: 50804-141-01; 0536-1217-94; 70000-0454-1; 41520-431-05; 24385-075-05 | Lack of Assurance of Sterility | K.C. Pharmaceuticals, Inc / 378,144 bottles | Class II | Ongoing |
| D-0410-2026 | 03-03-2026 | EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) Walgreens, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015; UPC 3 11917 20074 3; b) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; c) CVS Health, Distributed by :CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 43544 1; d) QC-Quality Choice, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-191-14; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01155 9; f) Foster & Thrive, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, NDC 70677-1158-1; g) GoodSense, Distributed By: Perrigo Direct Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-130-01; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03641 3; I) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02556 3; j) Fast Acting, CODE RED Eye Drops, Sterile, Distributed by: 4 Trees, LLC, NDC 83817-963-01. Package NDCs: 83324-191-14; 70677-1158-1; 50804-130-01; 83817-963-01 | Lack of Assurance of Sterility | K.C. Pharmaceuticals, Inc / 303,216 bottles | Class II | Ongoing |
| D-0412-2026 | 03-03-2026 | Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0457-1; b) Harris Teeter, Eye Drops, Ultra Lubricant, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 73588 1; c) Foster & Thrive, Lubricating Eye Drops, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1160-1; d) Walgreens Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20167 2; e) P high performance Eye drops, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 09876 3; f) Kroger high performance lubricant eye drops, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; g) Good Sense Ultra Lubricant Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; h) meijer Ultra Lubricant, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-937-01; i) CVS Health, Fast Acting Lubricant Eye Drops, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 39690 2; j) CVS Health, Fast Acting Lubricant Eye Drops, Twin pack, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 44738 3; k) QC-Quality Choice, Lubricant Eye Drops, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-029-15; l) AVENOVA LUBRICANT EYE DROPS, Twin pack, Distributed by: NovaBay Pharmaceuticals, Inc., CA 94608, UPC 8 57005 00411 9. Package NDCs: 70000-0457-1; 70000-0457-2; 70677-1160-1; 50804-160-01; 41250-937-01; 41250-937-02; 83324-029-15 | Lack of Assurance of Sterility | K.C. Pharmaceuticals, Inc / 245,184 bottles | Class II | Ongoing |
| D-0414-2026 | 03-03-2026 | Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) Industrial Eye Relief, Distributed by: Cintas Corp., Mason, OH 45040, UPC 130209; b) Good Neighbor Pharmacy Eye Drops, Redness & Dry Eye Relief, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-606-05; c) Colirio Ojo De Aguila Eye Drops, Distributed by: Grandall Distributing Co., Inc., Glendale, CA 91204-2707, UPC 3 48201 01615 5; d) Colirio OFTAL-MYCIN, Distributed by: Grandall Distributing Co., Inc., Glendale, CA 91204-2707, UPC 3 48201 01613 1; e) LEADER Redness Relief, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0010-1; f) Equaline, sterile redness relief, DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908, UPC 0 41163 46151 2; g) Walgreens, Redness Relief Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17741 0; h) Foster & Thrive, Redness Relief Eye Drops, Sterile, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1161-1; i) LUBRICANT EYE DROPS, Redness Relief, DISTRIBUTEDBY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011, NDC 11822-6453-4; j) Discount drug mart, Eye Drops Redness Relief, Distributed by: Discount Drug Mart, Medina, OH 44256, UPC 0 93351 03411 4 Package NDCs: 70000-0010-1; 70000-0010-2; 70677-1161-1; 46122-606-05; 11822-6453-4 | Lack of Assurance of Sterility | K.C. Pharmaceuticals, Inc / 315,144 bottles | Class II | Ongoing |
| D-0416-2026 | 03-03-2026 | Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; b) Good Sense, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-110-01; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-006-05; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; e) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47008 3; f) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7; g) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; h) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14 Package NDCs: 70000-0011-1; 50804-110-01; 24385-006-05; 83324-189-14 | Lack of Assurance of Sterility | K.C. Pharmaceuticals, Inc / 589,848 bottles | Class II | Ongoing |
| D-0409-2026 | 03-03-2026 | Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47010 6; b) QC-Quality Choice, Sterile Eye drops Irritation Relief, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-190-14; c) Discount drug mart, Eye Drops A.C., Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01158 0; d) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; e) Walgreens, Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17954 4; f) CAREONE, Itchy relief Eye drops, DISTRIBUTED BY: FOODHOLD U.S.A, LLC., LANDOVER, MD 20785; g) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; h) TopCare health TM, DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 03640 6; i) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-598-01; j) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43746 7 Package NDCs: 83324-190-14; 50804-160-01; 41250-598-01 | Lack of Assurance of Sterility | K.C. Pharmaceuticals, Inc / 182,424 bottles | Class II | Ongoing |
| D-0453-2026 | 03-03-2026 | HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottle; DIST BY HYDROPEPTIDE LLC, ISSAQUAH, WA 98027 | Chemical contamination: Presence of benzene | Owen Biosciences Inc. / 9,850 bottles | Class II | Ongoing |
| D-0455-2026 | 03-03-2026 | SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, CA 90232. | Chemical contamination: Presence of benzene | Owen Biosciences Inc. / 2,500 bottles | Class II | Ongoing |
| D-0452-2026 | 03-03-2026 | FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinney, Texas | Chemical contamination: Presence of benzene | Owen Biosciences Inc. / 7,975 tubes | Class II | Ongoing |
| D-0384-2026 | 03-03-2026 | Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51. Package NDCs: 16571-816-51; 16571-816-02; 16571-816-41; 16571-817-51; 16571-817-02; 16571-817-41; 16571-818-51; 16571-818-02; 16571-818-41; 16571-819-51; 16571-819-02; 16571-819-41; 16571-820-51; 16571-820-02; 16571-820-41; 16571-821-51; 16571-821-02 | Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing | Rising Pharma Holding, Inc. / 1200 bottles | Class II | Ongoing |
| D-0415-2026 | 03-03-2026 | STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LUBRICATING EYE DROPS, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1219-94; b) Walgreens, Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20300 3 | Lack of Assurance of Sterility | K.C. Pharmaceuticals, Inc / 74,016 bottles | Class II | Ongoing |
| D-0454-2026 | 03-03-2026 | SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Brands, Culver City, CA90232. | Chemical contamination: Presence of benzene | Owen Biosciences Inc. / 2269 bottles | Class II | Ongoing |
| D-0390-2026 | 03-02-2026 | Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8. Package NDCs: 51672-5321-8; 51672-5321-1 | Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. | STRIDES PHARMA INC / 89592 bottles | Class II | Ongoing |
| D-0528-2026 | 03-02-2026 | Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085. | Non-Sterility: microbial contamination identified as Paenibacillus phoenicis | Cardinal Health 200, LLC / 174,380,282 boxes | Class I | Ongoing |
| D-0394-2026 | 02-26-2026 | Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03. | Lack of Assurance of Sterility | New Life Pharma LLC / 23 vials | Class II | Ongoing |
| D-0393-2026 | 02-26-2026 | Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06 | Lack of Assurance of Sterility | New Life Pharma LLC / 2 vials | Class II | Ongoing |
| D-0392-2026 | 02-26-2026 | Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07. | Lack of Assurance of Sterility | New Life Pharma LLC / 820 vials | Class II | Ongoing |
| D-0395-2026 | 02-26-2026 | Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04. | Lack of Assurance of Sterility | New Life Pharma LLC / 45 vials | Class II | Ongoing |
| D-0403-2026 | 02-26-2026 | Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44 Package NDCs: 33342-393-10; 33342-393-11; 33342-393-44; 33342-394-10; 33342-394-11; 33342-394-44; 33342-395-10; 33342-395-11; 33342-395-44; 33342-396-10; 33342-396-11; 33342-396-44; 33342-397-10; 33342-397-11; 33342-397-44; 33342-398-10; 33342-398-11; 33342-398-44; 33342-399-10; 33342-399-11; 33342-399-44; 33342-400-10; 33342-400-11; 33342-400-44; 33342-401-10; 33342-401-11; 33342-401-44; 33342-402-10; 33342-402-11; 33342-402-44; 33342-403-10; 33342-403-11; 33342-403-44; 33342-404-10; 33342-404-11; 33342-404-44 | Subpotent Drug | MACLEODS PHARMA USA, INC / 1315 bottles | Class II | Ongoing |
| D-0399-2026 | 02-24-2026 | Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93. Package NDCs: 0378-6611-85; 0378-6611-93; 0378-6612-85; 0378-6612-93; 0378-6613-85; 0378-6613-93; 0378-6614-85; 0378-6614-93 | Failed Dissolution Specifications | MYLAN PHARMACEUTICALS INC / 34850 blister packs | Class II | Ongoing |
| D-0401-2026 | 02-19-2026 | Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35 Package NDCs: 69208-000-00; 69208-003-15; 69208-003-25; 69208-003-35 | Failed Tablet/Capsule Specifications | Radnostix / 2,699 blister cartons | Class III | Ongoing |
| D-0381-2026 | 02-18-2026 | Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17 Package NDCs: 69097-030-08; 69097-030-16; 69097-030-63; 69097-031-17; 69097-031-56; 69097-031-74; 69097-031-76; 69097-031-73; 69097-031-91; 69097-032-17; 69097-032-56; 69097-032-74; 69097-032-76; 69097-032-73; 69097-032-91 | Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. | Cipla USA, Inc. / 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules | Class III | Ongoing |
| D-0387-2026 | 02-18-2026 | MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015. | Stability Data Does Not Support Expiry Date. | HTO Nevada Inc. dba Kirkman / 243 bottles | Class II | Ongoing |
| D-0382-2026 | 02-18-2026 | Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each), NDC 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17 Package NDCs: 69097-030-08; 69097-030-16; 69097-030-63; 69097-031-17; 69097-031-56; 69097-031-74; 69097-031-76; 69097-031-73; 69097-031-91; 69097-032-17; 69097-032-56; 69097-032-74; 69097-032-76; 69097-032-73; 69097-032-91 | Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. | Cipla USA, Inc. / 164 cartons | Class III | Ongoing |
| D-0385-2026 | 02-18-2026 | FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016. | Stability Data Does Not Support Expiry Date. | HTO Nevada Inc. dba Kirkman / 27,380 bottles. | Class II | Ongoing |
| D-0386-2026 | 02-18-2026 | MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014. | Stability Data Does Not Support Expiry Date. | HTO Nevada Inc. dba Kirkman / 178 bottles | Class II | Ongoing |
| D-0383-2026 | 02-17-2026 | Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06. Package NDCs: 0904-6817-06; 0904-6817-61; 0904-6818-06; 0904-6818-61; 0904-6819-07 | Defective container; inadequately sealed blister packaging. | The Harvard Drug Group LLC / 8892 cartons | Class II | Ongoing |
| D-0341-2026 | 02-13-2026 | Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15. Package NDCs: 50268-069-11; 50268-069-15 | Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution. | AvKARE / N/A | Class II | Ongoing |
| D-0379-2026 | 02-13-2026 | Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China | CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution | Harbin Jixianglong Biotech Co., Ltd. / N/A | Class II | Ongoing |
| D-0380-2026 | 02-13-2026 | Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China. | CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution | Harbin Jixianglong Biotech Co., Ltd. / N/A | Class II | Ongoing |
| D-0343-2026 | 02-12-2026 | Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80 Package NDCs: 70436-026-80; 70436-027-80; 70436-162-80; 70436-163-80 | Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion. | Slate Run Pharmaceuticals / N/A | Class III | Ongoing |
| D-0339-2026 | 02-10-2026 | Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA, Package NDCs: 50222-346-01; 50222-346-02; 50222-346-22; 50222-346-04; 50222-346-91; 50222-346-92; 50222-350-00; 50222-350-01; 50222-350-02; 50222-350-90; 50222-350-91 | Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber. | LEO PHARMA INC / 11,407 units | Class II | Ongoing |
| D-0340-2026 | 02-09-2026 | Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90. Package NDCs: 71288-558-90; 71288-556-02; 71288-557-81 | Defective Delivery System: Missing or duplicated needles within the injection kit | Meitheal Pharmaceuticals, Inc / 16,477 kits | Class II | Ongoing |
| D-0337-2026 | 02-05-2026 | vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59. | Lack of Assurance of Sterility | Fresenius Kabi Compounding, LLC / N/A | Class II | Ongoing |
| D-0334-2026 | 02-05-2026 | ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56 | Lack of Assurance of Sterility | Fresenius Kabi Compounding, LLC / 1410 bags | Class II | Ongoing |
| D-0336-2026 | 02-05-2026 | vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59 | Lack of Assurance of Sterility | Fresenius Kabi Compounding, LLC / 1578 bags | Class II | Ongoing |
| D-0335-2026 | 02-05-2026 | thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56. | Lack of Assurance of Sterility | Fresenius Kabi Compounding, LLC / 10,548 bags | Class II | Ongoing |
| D-0333-2026 | 02-05-2026 | acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56 | Lack of Assurance of Sterility | Fresenius Kabi Compounding, LLC / 1057 bags | Class II | Ongoing |
| D-0398-2026 | 02-04-2026 | Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01 Package NDCs: 70069-025-10; 70069-025-01 | Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate. | SOMERSET THERAPEUTICS LLC / 62190 vials | Class II | Ongoing |
| D-0391-2026 | 02-03-2026 | Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01. Package NDCs: 72603-479-01; 72603-480-01 | Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg | Annora Pharma Private Limited / 770 bottles | Class III | Ongoing |
| D-0303-2026 | 02-02-2026 | Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-112-11 Package NDCs: 83389-112-11 | cGMP deviations | Pro Numb Tattoo Numbing Spray LLC / N/A | Class II | Ongoing |
| D-0302-2026 | 02-02-2026 | Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11 Package NDCs: 83389-111-11 | cGMP deviations | Pro Numb Tattoo Numbing Spray LLC / N/A | Class II | Ongoing |
| D-0354-2026 | 01-29-2026 | Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054 Package NDCs: 45963-709-11; 45963-709-96; 45963-676-11; 45963-676-96; 45963-677-11; 45963-677-96; 45963-678-11 | Failed Dissolution Specifications | Teva Pharmaceuticals USA, Inc / 18,780 bottles | Class II | Ongoing |
| D-0356-2026 | 01-29-2026 | Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054. Package NDCs: 45963-709-11; 45963-709-96; 45963-676-11; 45963-676-96; 45963-677-11; 45963-677-96; 45963-678-11 | Failed Dissolution Specifications | Teva Pharmaceuticals USA, Inc / 7,448 bottles | Class II | Ongoing |
| D-0355-2026 | 01-29-2026 | Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054 Package NDCs: 45963-709-11; 45963-709-96; 45963-676-11; 45963-676-96; 45963-677-11; 45963-677-96; 45963-678-11 | Failed Dissolution Specifications | Teva Pharmaceuticals USA, Inc / 67,043 bottles | Class II | Ongoing |
| D-0357-2026 | 01-29-2026 | Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11 Package NDCs: 45963-709-11; 45963-709-96; 45963-676-11; 45963-676-96; 45963-677-11; 45963-677-96; 45963-678-11 | Failed Dissolution Specifications | Teva Pharmaceuticals USA, Inc / 19,056 bottles | Class II | Ongoing |
| D-0342-2026 | 01-27-2026 | Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7 Package NDCs: 51672-1363-3; 51672-1363-7 | Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
| D-0305-2026 | 01-26-2026 | Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01. Package NDCs: 70010-231-03; 70010-231-01; 70010-231-05; 70010-231-10; 70010-232-03; 70010-232-01; 70010-232-05; 70010-232-10; 70010-233-03; 70010-233-01; 70010-233-05; 70010-234-03; 70010-234-01; 70010-234-05 | Presence of Foreign Tablets/Capsules | Granules Pharmaceuticals Inc. / 71424 bottles. | Class II | Ongoing |
| D-0318-2026 | 01-26-2026 | Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 89,074 pellets | Class II | Ongoing |
| D-0329-2026 | 01-26-2026 | Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 7,840 pellets | Class II | Ongoing |
| D-0315-2026 | 01-26-2026 | ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 715 pellets | Class II | Ongoing |
| D-0312-2026 | 01-26-2026 | ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 1,475 pellets | Class II | Ongoing |
| D-0330-2026 | 01-26-2026 | Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 1,631 pellets | Class II | Ongoing |
| D-0308-2026 | 01-26-2026 | ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 24,099 pellets | Class II | Ongoing |
| D-0326-2026 | 01-26-2026 | Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 100 pellets | Class II | Ongoing |
| D-0324-2026 | 01-26-2026 | Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 194,336 pellets | Class II | Ongoing |
| D-0320-2026 | 01-26-2026 | Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 70,959 pellets. | Class II | Ongoing |
| D-0323-2026 | 01-26-2026 | Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 153,498 pellets | Class II | Ongoing |
| D-0322-2026 | 01-26-2026 | Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 62,581 pellets. | Class II | Ongoing |
| D-0310-2026 | 01-26-2026 | ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 14,848 pellets | Class II | Ongoing |
| D-0319-2026 | 01-26-2026 | Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 60,868 pellets. | Class II | Ongoing |
| D-0314-2026 | 01-26-2026 | ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 2,442 pellets. | Class II | Ongoing |
| D-0313-2026 | 01-26-2026 | ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 133 pellets | Class II | Ongoing |
| D-0331-2026 | 01-26-2026 | Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32 | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 1,464 pellets. | Class II | Ongoing |
| D-0321-2026 | 01-26-2026 | Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 1,758 pellets. | Class II | Ongoing |
| D-0311-2026 | 01-26-2026 | ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 1,699 pellets | Class II | Ongoing |
| D-0316-2026 | 01-26-2026 | Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 3,871 pellets | Class II | Ongoing |
| D-0389-2026 | 01-26-2026 | Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID. Package NDCs: 69208-000-00; 69208-003-15; 69208-003-25; 69208-003-35 | Presence of Particulate Matter: Due to production issues | Radnostix / 16 units | Class II | Ongoing |
| D-0307-2026 | 01-26-2026 | ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 50,990 pellets | Class II | Ongoing |
| D-0327-2026 | 01-26-2026 | Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 670 pellets | Class II | Ongoing |
| D-0325-2026 | 01-26-2026 | Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 1,015 pellets | Class II | Ongoing |
| D-0317-2026 | 01-26-2026 | Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 146 pellets | Class II | Ongoing |
| D-0328-2026 | 01-26-2026 | Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 4,599 pellets | Class II | Ongoing |
| D-0309-2026 | 01-26-2026 | ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 22,478 pellets. | Class II | Ongoing |
| D-0306-2026 | 01-21-2026 | Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by Unichem Laboratories Limited, Plot Number 15 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa (India) 403511, NDC 29300-353-10. Package NDCs: 29300-351-13; 29300-351-01; 29300-351-10; 29300-352-13; 29300-352-01; 29300-352-10; 29300-353-13; 29300-353-01; 29300-353-10; 29300-354-13; 29300-354-01; 29300-354-10 | Tablets/Capsules Imprinted with Wrong ID | Unichem Pharmaceuticals USA Inc. / 60,000 tablets | Class III | Ongoing |
| D-0301-2026 | 01-21-2026 | Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01 Package NDCs: 29300-187-13; 29300-187-01; 29300-187-05; 29300-187-10; 29300-188-13; 29300-188-01; 29300-188-05; 29300-188-10; 29300-189-13; 29300-189-01; 29300-189-05; 29300-189-10 | cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. | Unichem Pharmaceuticals USA Inc. / N/A | Class II | Ongoing |
| D-0372-2026 | 01-20-2026 | WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01. | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0371-2026 | 01-20-2026 | Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr., Stelton, CT 06484, NDC 0924-0243-01. Package NDCs: 0924-0243-00; 0924-0243-01 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0359-2026 | 01-20-2026 | First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03. Package NDCs: 0924-7116-00; 0924-7116-04; 0924-7116-05; 0924-7116-03; 0924-7116-01; 0924-7116-02 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0361-2026 | 01-20-2026 | First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC, 27801 Made in USA, NDC 0924-7116-00. Package NDCs: 0924-7116-00; 0924-7116-04; 0924-7116-05; 0924-7116-03; 0924-7116-01; 0924-7116-02 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0365-2026 | 01-20-2026 | Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box, Manufactured for Medique Products, Fort Meyers, FL, 33967, NDC 47682-122-33. Package NDCs: 47682-122-99; 47682-122-71; 47682-122-33; 47682-252-99; 47682-252-71 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0360-2026 | 01-20-2026 | Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonkoma, NY 11779, Made in USA, NDC 65517-0004-1 Package NDCs: 65517-0004-1; 65517-0004-2 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0374-2026 | 01-20-2026 | Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73 Package NDCs: 47682-056-99; 47682-056-73; 47682-056-33 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0367-2026 | 01-20-2026 | BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0246-02. Package NDCs: 0924-0246-00; 0924-0246-01; 0924-0246-02; 0924-0246-03 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0362-2026 | 01-20-2026 | 1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 2) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Touchpoint, 1000 ea Bulk, Made in USA for : Food Service Resources, Flowery Branch, GA 30542. NDC 0924-7130-00. 3) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Wellstar Cobb Hand Wipes, 1000 ea Bulk, Made in the USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 4) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" FSR Sanitizing Hand Wipes, 1000 ea Bulk, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. Inner Packaging - Instant Hand Sanitizing Wipes 5) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x7" Children's 1000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542 NDC 0924-713-00. Inner packaging -Children's Healthcare of Atlanta | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0373-2026 | 01-20-2026 | Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-00 Package NDCs: 0924-0301-00; 0924-0301-04; 0924-0301-05 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
