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-0151-2024 | 11-22-2023 | TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591, UPC 363736532611. | Chemical Contamination; presence of benzene. | Insight Pharmaceuticals Corporation / 117,336 cans | Class I | Completed |
| D-0144-2024 | 11-22-2023 | SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. NDC 0078-0110-22 | Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals | Novartis Pharmaceuticals Corporation / 6,997 bottles | Class I | Ongoing |
| D-0148-2024 | 11-22-2023 | Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01 Package NDCs: 70748-153-01 | Failed Dissolution Specifications | Lupin Pharmaceuticals Inc. / N/A | Class II | Terminated |
| D-0149-2024 | 11-20-2023 | Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Valles, Spain, Distributed by: Novartis Pharmaceuticals Corp., East Hanover, N.J. 07936, NDC 0078-1077-66 Package NDCs: 0078-1077-66 | Failed Dissolution Specifications | Siegfried Barbera, SL / 2016 | Class III | Completed |
| D-0220-2024 | 11-17-2023 | Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, NDC 69097-964-53 Package NDCs: 69097-964-53 | Defective Container: powder may leak out of the pouch | InvaGen Pharmaceuticals, Inc. / 1240 boxes | Class I | Completed |
| D-0146-2024 | 11-14-2023 | Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 382213, India. NDC 36000-012-25 Package NDCs: 36000-012-25; 36000-013-01 | Failed pH Specifications | Baxter Healthcare Corporation / 6,022,675 vials | Class II | Completed |
| D-0291-2024 | 11-13-2023 | Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017 Package NDCs: 70000-0090-1; 70000-0090-2 | Non-Sterility | Kilitch Healthcare India Limited / 210,192 bottles | Class I | Ongoing |
| D-0299-2024 | 11-13-2023 | Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0089-1 Package NDCs: 70000-0089-1 | Non-Sterility | Kilitch Healthcare India Limited / 23,208 bottles | Class I | Ongoing |
| D-0297-2024 | 11-13-2023 | Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0087-1 Package NDCs: 70000-0087-1 | Non-Sterility | Kilitch Healthcare India Limited / 10,944 bottles | Class I | Ongoing |
| D-0295-2024 | 11-13-2023 | Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by Cardinal Health Dublin, Ohio 43017, NDC 70000-0088-1 Package NDCs: 70000-0088-1 | Non-Sterility | Kilitch Healthcare India Limited / 12,960 bottles | Class I | Ongoing |
| D-0293-2024 | 11-13-2023 | Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94 | Non-Sterility | Kilitch Healthcare India Limited / 1,492,344 bottles | Class I | Ongoing |
| D-0302-2024 | 11-13-2023 | Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles of 0.33 FL OZ (10 mL) each, Velocity Pharma, NDC 76168-502-30 | Non-Sterility | Kilitch Healthcare India Limited / 2,820 bottles | Class I | Ongoing |
| D-0308-2024 | 11-13-2023 | Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-2254-3 | Non-Sterility | Kilitch Healthcare India Limited / 9,216 bottles | Class I | Ongoing |
| D-0301-2024 | 11-13-2023 | Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0587-1 | Non-Sterility | Kilitch Healthcare India Limited / 14,784 bottles | Class I | Ongoing |
| D-0304-2024 | 11-13-2023 | LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-5 | Non-Sterility | Kilitch Healthcare India Limited / 6,024 bottles | Class I | Ongoing |
| D-0292-2024 | 11-13-2023 | CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (NDC 76168-714-10) and b) 0.33 FL OZ (10 mL) bottles (Twin pack) (NDC 76168-714-20), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. | Non-Sterility | Kilitch Healthcare India Limited / 137,784 bottles | Class I | Ongoing |
| D-0305-2024 | 11-13-2023 | CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-711-15 | Non-Sterility | Kilitch Healthcare India Limited / 45,408 bottles | Class I | Ongoing |
| D-0307-2024 | 11-13-2023 | Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-3 | Non-Sterility | Kilitch Healthcare India Limited / 7,776 bottles | Class I | Ongoing |
| D-0309-2024 | 11-13-2023 | Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-3 Retail Labeler: Rite Aid | Non-Sterility | Kilitch Healthcare India Limited / 7,296 bottles | Class I | Ongoing |
| D-0303-2024 | 11-13-2023 | EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bottles, Distributed by: Walmart Inc., Bentonville, AR 72712, NDC 79903-168-01 | Non-Sterility | Kilitch Healthcare India Limited / 33,984 bottles | Class I | Ongoing |
| D-0294-2024 | 11-13-2023 | CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-712-10 | Non-Sterility | Kilitch Healthcare India Limited / 110,832 bottles | Class I | Ongoing |
| D-0298-2024 | 11-13-2023 | CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-704-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-704-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. | Non-Sterility | Kilitch Healthcare India Limited / 150,720 bottles | Class I | Ongoing |
| D-0311-2024 | 11-13-2023 | Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by: Target Corporation Minneapolis, MN 55403, NDC 76168-800-30 | Non-Sterility | Kilitch Healthcare India Limited / 137,544 bottles | Class I | Ongoing |
| D-0296-2024 | 11-13-2023 | CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL) bottles, Distributed by CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-706-15 | Non-Sterility | Kilitch Healthcare India Limited / 253,080 bottles | Class I | Ongoing |
| D-0306-2024 | 11-13-2023 | Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-5 | Non-Sterility | Kilitch Healthcare India Limited / 7,200 bottles | Class I | Ongoing |
| D-0300-2024 | 11-13-2023 | Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 11673-522-30), Distributed by: Target Corporation Minneapolis, MN 55403 | Non-Sterility | Kilitch Healthcare India Limited / 401,568 bottles | Class I | Ongoing |
| D-0310-2024 | 11-13-2023 | Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94 | Non-Sterility | Kilitch Healthcare India Limited / 56,520 bottles | Class I | Ongoing |
| D-0290-2024 | 11-13-2023 | CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-702-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-702-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. | Non-Sterility | Kilitch Healthcare India Limited / 386,256 bottles | Class I | Ongoing |
| D-0143-2024 | 11-13-2023 | KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ (59 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-096-02, UPC 850001805698. Package NDCs: 82673-096-02; 8500018056 | Failed Impurities/Degradation Specifications | KINDER FARMS LLC / 376,370 bottles | Class II | Ongoing |
| D-0142-2024 | 11-13-2023 | KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-097-04, UPC 850001805728. Package NDCs: 82673-097-04; 8500018057 | Failed Impurities/Degradation Specifications | KINDER FARMS LLC / 591,684 bottles | Class II | Ongoing |
| D-0125-2024 | 11-10-2023 | Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This is a Compounded Drug, Hospital & Office Use Only, Fagron Sterile Services, 8710 E 34th St N Wichita, KS 67226. NDC 71266-8240-01 | Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper | Fagron Compounding Services / 756 bottles | Class III | Ongoing |
| D-0130-2024 | 11-10-2023 | PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012. Package NDCs: 60429-734-30; 60429-734-90; 60429-734-10; 60429-735-30; 60429-735-90; 60429-735-10; 60429-736-30; 60429-736-90; 60429-736-10; 60429-737-30; 60429-737-90; 60429-737-10 | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine | Golden State Medical Supply Inc. / 5626 bottles | Class II | Terminated |
| D-0127-2024 | 11-10-2023 | Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30 Package NDCs: 0591-2924-18; 0591-2925-32; 0591-2925-30; 0591-2926-25; 0591-2926-30 | OOS for viscosity | Teva Pharmaceuticals USA, Inc / | Class III | Terminated |
| D-0129-2024 | 11-10-2023 | PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012. Package NDCs: 60429-734-30; 60429-734-90; 60429-734-10; 60429-735-30; 60429-735-90; 60429-735-10; 60429-736-30; 60429-736-90; 60429-736-10; 60429-737-30; 60429-737-90; 60429-737-10 | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine | Golden State Medical Supply Inc. / 2502 bottles | Class II | Terminated |
| D-0128-2024 | 11-10-2023 | PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012. Package NDCs: 60429-734-30; 60429-734-90; 60429-734-10; 60429-735-30; 60429-735-90; 60429-735-10; 60429-736-30; 60429-736-90; 60429-736-10; 60429-737-30; 60429-737-90; 60429-737-10 | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine | Golden State Medical Supply Inc. / 1941 bottles | Class II | Terminated |
| D-0106-2024 | 11-09-2023 | Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W Cumberland St. Dunn, NC 28334. | cGMP Deviations | Family Medical Supply Inc / 26,657 Cylinders | Class II | Terminated |
| D-0411-2024 | 11-09-2023 | labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 2,458, syringes | Class II | Terminated |
| D-0399-2024 | 11-09-2023 | fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 324 syringes | Class II | Terminated |
| D-0394-2024 | 11-09-2023 | Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 381 Bags | Class II | Terminated |
| D-0415-2024 | 11-09-2023 | PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11, Bar Code 70004081011 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 7,198 syringes; expanded 1,289 syringes | Class II | Terminated |
| D-0398-2024 | 11-09-2023 | fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-64, Bar Code 70004023164 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 613 Cassettes | Class II | Terminated |
| D-0425-2024 | 11-09-2023 | VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 368 bags | Class II | Terminated |
| D-0409-2024 | 11-09-2023 | HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-16, Bar Code 70004030316 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 5392 syringes | Class II | Terminated |
| D-0420-2024 | 11-09-2023 | PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040081612. | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 3,671 syringes, expanded 1,911 syringes | Class II | Terminated |
| D-0418-2024 | 11-09-2023 | PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Code 70004081112. | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 10,017 syringes, expanded 2579 syringes | Class II | Terminated |
| D-0412-2024 | 11-09-2023 | Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 1,508 bags; expanded 1,015 bags | Class II | Terminated |
| D-0407-2024 | 11-09-2023 | HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 1,023 syringes | Class II | Terminated |
| D-0406-2024 | 11-09-2023 | HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 70004030018 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 1,425 syringes | Class II | Terminated |
| D-0397-2024 | 11-09-2023 | fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-32, Bar Code 70004023132 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 242 bags | Class II | Terminated |
| D-0419-2024 | 11-09-2023 | PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540. | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 400 bags | Class II | Terminated |
| D-0402-2024 | 11-09-2023 | fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0200-17, Bar code 70004020017 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 1,259 syringes | Class II | Terminated |
| D-0403-2024 | 11-09-2023 | fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022, | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 500 syringes | Class II | Terminated |
| D-0140-2024 | 11-09-2023 | LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 190, Irving, TX 75063, NDC73271-1003-1 | Product Mix-up: Incorrect Product Formulation | Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop / 190 syringes | Class III | Terminated |
| D-0424-2024 | 11-09-2023 | SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 70004090809 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 5,079 syringe | Class II | Terminated |
| D-0413-2024 | 11-09-2023 | neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 1,122 syringes | Class II | Terminated |
| D-0421-2024 | 11-09-2023 | PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12-K, Bar Code 700040081612. (same finished product as F078140, but with RFID for KitCheck compatibility) | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 2,427 syringes | Class II | Terminated |
| D-0395-2024 | 11-09-2023 | fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 BAR code 70004022940 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 548 bags | Class II | Terminated |
| D-0404-2024 | 11-09-2023 | HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 70004030063 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 256 cassettes | Class II | Terminated |
| D-0423-2024 | 11-09-2023 | SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-12, Bar Code 70004090812 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 8,755 syringe | Class II | Terminated |
| D-0408-2024 | 11-09-2023 | HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 7004030317 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 399 syringes | Class II | Terminated |
| D-0422-2024 | 11-09-2023 | Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 9,624 syringes | Class II | Terminated |
| D-0396-2024 | 11-09-2023 | fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 500 bags | Class II | Terminated |
| D-0405-2024 | 11-09-2023 | HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-16, Bar Code 70004030016 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 5,734 syringes | Class II | Terminated |
| D-0410-2024 | 11-09-2023 | HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 909 syringes | Class II | Terminated |
| D-0401-2024 | 11-09-2023 | fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0251-64, Bar Code 70004025164 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 130 cassettes | Class II | Terminated |
| D-0400-2024 | 11-09-2023 | fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0289-64, Bar Code 70004028964 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 412 cassettes | Class II | Terminated |
| D-0414-2024 | 11-09-2023 | PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 70004081012 | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 33,072 syringes; expanded 9,041 syringes | Class II | Terminated |
| D-0416-2024 | 11-09-2023 | PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID for KitCheck | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 1,118 syringes in kits | Class II | Terminated |
| D-0417-2024 | 11-09-2023 | PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022. | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC / 5,948 syringes, expanded 2,102 syringes | Class II | Terminated |
| D-0138-2024 | 11-08-2023 | Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b) 120 count (UPC 1 95893 54697 8), c) 180 count (UPC 1 95893 99957 6) bottles, Manufactured for SUGARMDS LLC, Port St. Lucie, FL 34952. | MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide | SUGARMDS LLC / 32,117 | Class I | Ongoing |
| D-0124-2024 | 11-07-2023 | Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-188-01. Package NDCs: 68462-188-01; 68462-188-05; 68462-189-01; 68462-189-05; 68462-190-30; 68462-190-50; 68462-190-01; 68462-190-05; 68462-178-01; 68462-178-05; 68462-179-01; 68462-179-05 | Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen | Glenmark Pharmaceuticals Inc., USA / | Class II | Ongoing |
| D-0123-2024 | 11-07-2023 | Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-406-01 Package NDCs: 68462-406-01; 68462-406-10; 68462-302-01; 68462-302-05 | Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen | Glenmark Pharmaceuticals Inc., USA / 37,200 bottles | Class II | Ongoing |
| D-0089-2024 | 11-06-2023 | Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1 Package NDCs: 51672-3007-1 | Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing. | Taro Pharmaceuticals Inc. / 11,196 bottles | Class III | Terminated |
| D-0145-2024 | 11-06-2023 | VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01 Package NDCs: 50419-390-01; 50419-391-01; 50419-392-01; 50419-393-02; 50419-393-03 | Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing | Bayer Healthcare Pharmaceuticals Inc. / 192 bottles | Class I | Terminated |
| D-0119-2024 | 11-01-2023 | Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326. Package NDCs: 60505-0097-1; 60505-0097-9; 60505-0097-2; 60505-0097-4; 60505-0097-7; 60505-0097-5; 60505-0083-1; 60505-0083-9; 60505-0083-2; 60505-0083-4; 60505-0083-0; 60505-0083-5; 60505-0084-1; 60505-0084-9; 60505-0084-2; 60505-0084-4; 60505-0084-5; 60505-0101-1; 60505-0101-9; 60505-0101-2; 60505-0101-4; 60505-0101-5; 60505-0101-7 | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine | Apotex Corp. / 34,392 | Class II | Ongoing |
| D-0120-2024 | 11-01-2023 | Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326. Package NDCs: 60505-0097-1; 60505-0097-9; 60505-0097-2; 60505-0097-4; 60505-0097-7; 60505-0097-5; 60505-0083-1; 60505-0083-9; 60505-0083-2; 60505-0083-4; 60505-0083-0; 60505-0083-5; 60505-0084-1; 60505-0084-9; 60505-0084-2; 60505-0084-4; 60505-0084-5; 60505-0101-1; 60505-0101-9; 60505-0101-2; 60505-0101-4; 60505-0101-5; 60505-0101-7 | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine | Apotex Corp. / 48,623 | Class II | Ongoing |
| D-0121-2024 | 11-01-2023 | Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326. Package NDCs: 60505-0097-1; 60505-0097-9; 60505-0097-2; 60505-0097-4; 60505-0097-7; 60505-0097-5; 60505-0083-1; 60505-0083-9; 60505-0083-2; 60505-0083-4; 60505-0083-0; 60505-0083-5; 60505-0084-1; 60505-0084-9; 60505-0084-2; 60505-0084-4; 60505-0084-5; 60505-0101-1; 60505-0101-9; 60505-0101-2; 60505-0101-4; 60505-0101-5; 60505-0101-7 | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine | Apotex Corp. / 25,776 | Class II | Ongoing |
| D-0122-2024 | 11-01-2023 | Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326. Package NDCs: 60505-0097-1; 60505-0097-9; 60505-0097-2; 60505-0097-4; 60505-0097-7; 60505-0097-5; 60505-0083-1; 60505-0083-9; 60505-0083-2; 60505-0083-4; 60505-0083-0; 60505-0083-5; 60505-0084-1; 60505-0084-9; 60505-0084-2; 60505-0084-4; 60505-0084-5; 60505-0101-1; 60505-0101-9; 60505-0101-2; 60505-0101-4; 60505-0101-5; 60505-0101-7 | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine | Apotex Corp. / 4,074 | Class II | Ongoing |
| D-0139-2024 | 11-01-2023 | Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand, India Distributed By: Padagis, Allegan, MI 49010. NDC: 0574-0118-30 Package NDCs: 0574-0118-30 | Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules | Padagis US LLC / 7,032 bottles | Class II | Ongoing |
| D-0136-2024 | 10-31-2023 | LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0587-1 | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. | Cardinal Health Inc. / 8,784 bottles | Class I | Ongoing |
| D-0135-2024 | 10-31-2023 | LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0088-1 Package NDCs: 70000-0088-1 | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. | Cardinal Health Inc. / 11,782 bottles | Class I | Ongoing |
| D-0134-2024 | 10-31-2023 | LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC:70000-0090-2 (Carton); 70000-0090-1 (Bottle) Package NDCs: 70000-0090-1; 70000-0090-2 | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. | Cardinal Health Inc. / 28477 cartons | Class I | Ongoing |
| D-0107-2024 | 10-31-2023 | Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94. | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 1,271,810 bottles | Class I | Terminated |
| D-0132-2024 | 10-31-2023 | LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio. 43017, Made in India NDC: 70000-0089-1 Package NDCs: 70000-0089-1 | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. | Cardinal Health Inc. / 21,802 bottles | Class I | Ongoing |
| D-0131-2024 | 10-31-2023 | LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0087-1 Package NDCs: 70000-0087-1 | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. | Cardinal Health Inc. / 11629 units | Class I | Ongoing |
| D-0108-2024 | 10-31-2023 | Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94 | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 65,880 bottles | Class I | Terminated |
| D-0133-2024 | 10-31-2023 | LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0090-1 Package NDCs: 70000-0090-1; 70000-0090-2 | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. | Cardinal Health Inc. / 119,871 bottles | Class I | Ongoing |
| D-0099-2024 | 10-30-2023 | V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd., Melbourne, FL 32935 | Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label). | Grato Holdings, Inc. / 1,333 30mL bottles | Class III | Terminated |
| D-0114-2024 | 10-27-2023 | Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By Lupin, PKG by Vangard Glasgow, KY 42141. Package NDCs: 0615-7714-39; 0615-7714-05; 0615-7714-30; 0615-7718-39; 0615-7718-31; 0615-7718-05; 0615-7718-28; 0615-7689-39; 0615-7689-31; 0615-7689-05; 0615-8252-39; 0615-8252-05; 0615-8253-39; 0615-8253-05; 0615-8253-30; 0615-8256-39; 0615-8256-05; 0615-8254-39; 0615-8254-05; 0615-8254-30; 0615-8255-39; 0615-8255-05; 0615-8255-30 | Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots | NCS Healthcare of Kentucky Inc / 12 cards | Class III | Terminated |
| D-0090-2024 | 10-27-2023 | Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10 Package NDCs: 65162-212-03; 65162-212-10; 65162-212-50; 65162-212-11 | Failed Dissolution Specifications | Amneal Pharmaceuticals of New York, LLC / 9,263 100-count bottles | Class II | Terminated |
| D-0113-2024 | 10-27-2023 | Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141. Package NDCs: 0615-7714-39; 0615-7714-05; 0615-7714-30; 0615-7718-39; 0615-7718-31; 0615-7718-05; 0615-7718-28; 0615-7689-39; 0615-7689-31; 0615-7689-05 | Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots | NCS Healthcare of Kentucky Inc / 1,344 cards | Class III | Terminated |
| D-0093-2024 | 10-26-2023 | Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08. Package NDCs: 66689-307-08 | Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water. | VistaPharm LLC / 11,633 bottles | Class III | Terminated |
| D-0092-2024 | 10-23-2023 | Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60. Package NDCs: 68462-319-60; 68462-319-05; 68462-320-60; 68462-320-05 | Failed Dissolution Specifications: Out of specification for dissolution. | Glenmark Pharmaceuticals Inc., USA / 16,944 bottles | Class II | Ongoing |
| D-0153-2024 | 10-23-2023 | Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152 | Failed Content Uniformity Specifications | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 3718 saleable units | Class I | Terminated |
| D-0112-2024 | 10-23-2023 | Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, Package NDCs: 68462-390-30; 68462-390-90; 68462-390-10; 68462-391-30; 68462-391-90; 68462-391-10 | Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH). | Glenmark Pharmaceuticals Inc., USA / 8,448 30-count bottles, 168 1000-count bottles | Class III | Terminated |
| D-0094-2024 | 10-20-2023 | Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11 Package NDCs: 69344-113-11; 69344-213-11 | Sub-potent Drug: Lower potency than labeled. | Zyla Life Sciences US Inc. / 3,792 bottles | Class III | Ongoing |
| D-0085-2024 | 10-20-2023 | Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01 Package NDCs: 68462-878-30; 68462-878-01; 68462-878-05; 68462-879-30; 68462-879-01; 68462-879-05; 68462-880-30; 68462-880-01; 68462-880-05 | Failed Impurities/Degradation Specifications | Glenmark Pharmaceuticals Inc., USA / 480 100-count bottles | Class III | Terminated |
| D-0115-2024 | 10-20-2023 | Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for ITF Pharma, Inc., Berwyn, PA 19312 USA NDC:70726-0303-1 (carton) and 70726-0303-2 (bottle) Package NDCs: 70726-0303-2; 70726-0303-1 | Failed Viscosity Specifications: Out-of-specification test results for viscosity | ITF PHARMA INC / 1,792 bottles | Class II | Terminated |
| D-0104-2024 | 10-20-2023 | DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00030 4 | Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established. | Omega & Delta Co., Inc. / 23,136 8 OZ bottles | Class II | Ongoing |
| D-0103-2024 | 10-20-2023 | DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00027 4 | Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established. | Omega & Delta Co., Inc. / 48,145 4 oz bottles | Class II | Ongoing |
