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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0895-2023 | 06-26-2023 | Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram- 603 110, Tamilnadu, India, NDC 64380-933-08 Package NDCs: 64380-933-04; 64380-933-05; 64380-933-08; 64380-934-04; 64380-934-05; 64380-934-08; 64380-935-04; 64380-935-05; 64380-935-08 | Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet. | Strides Pharma Inc. / 2,700 HDPE Bottles | Class II | Terminated |
| D-0894-2023 | 06-26-2023 | Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited. Package NDCs: 68788-7781-2; 68788-7781-3; 68788-7781-6; 68788-7781-9; 68788-7781-1; 68788-7781-8 | Failed Stability Specifications | Preferred Pharmaceuticals, Inc. / 541 Bottles | Class II | Ongoing |
| D-0896-2023 | 06-23-2023 | PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UPC: N3 62541-401-10 5, NDC 62541-401-10, Package NDCs: 62541-402-10; 62541-403-10; 62541-404-10; 62541-405-10; 62541-401-10; 62541-406-50; 62541-406-10 | Failed Stability Specifications | Vivus, Inc. / 4240 bottles | Class III | Ongoing |
| D-1081-2023 | 06-23-2023 | Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg), packaged in 1 blister of 28 tablets each (NDC 68180-904-71) further packaged in a carton of 3 blisters (NDC 68180-904-73), Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by Lupin Limited, Pithampur (M.P.), INDIA Package NDCs: 68180-904-73; 68180-905-74; 68180-910-74; 68180-904-71 | Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test | Lupin Pharmaceuticals Inc. / 4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch | Class I | Terminated |
| D-0892-2023 | 06-23-2023 | Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode (01) 003 68084 645 11 2. Package NDCs: 68084-645-11; 68084-645-01; 68084-645-65; 68084-775-95; 68084-775-25 | Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution. | Amerisource Health Services LLC / 4,971 cartons | Class II | Terminated |
| D-0943-2023 | 06-23-2023 | Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807 | CGMP Deviations: use of non-food grade lubricant in mixing vessel. | Kramer Laboratories, Inc. / N/A | Class II | Terminated |
| D-0942-2023 | 06-23-2023 | Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807 | CGMP Deviations: use of non-food grade lubricant in mixing vessel. | Kramer Laboratories, Inc. / N/A | Class II | Terminated |
| D-0941-2023 | 06-22-2023 | Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division) Karakhadi, Vadodara 391450, India. NDC 62332-487-12 Package NDCs: 62332-487-12 | Defective Delivery System | ALEMBIC PHARMACEUTICALS, INC. / 2844 units | Class II | Ongoing |
| D-0923-2023 | 06-21-2023 | Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10 Package NDCs: 55111-179-30; 55111-179-15; 55111-179-03; 55111-179-10; 55111-180-30; 55111-180-15; 55111-180-03; 55111-180-10 | Failed dissolution specification: Out of specification results observed in 24-month long term stability testing. | Dr Reddy's Laboratories Limited / 17,548 1000-countbottles | Class II | Ongoing |
| D-0878-2023 | 06-16-2023 | Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61 | Packaging defect: blister packaging inadequately sealed. | The Harvard Drug Group / 3876 cartons | Class II | Terminated |
| D-0875-2023 | 06-13-2023 | Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13 Package NDCs: 50268-772-11; 50268-772-13 | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | AVKARE LLC / 592 cartons | Class III | Ongoing |
| D-0898-2023 | 06-13-2023 | Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ (15mL) bottle, packaged in a) equate, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716, 2-0.5 FL OZ (15 mL) Bottles, 1 FL OZ (30 mL) TOTAL, UPC 6 81131 36701 1, NDC 49035-280-02; b) DG health, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; c) sunmark, Distributed By McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 10939 62144 3, NDC 49348-037-29; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; e) HealthMart, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 52569 13715 4; f) exchange select Artificial Tears, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; g) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, UPC 7 13733 29692 2, NDC 41250-718-01; h) H.E.B, MADE WITH PRIDE AND CARE FOR H.E.B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; i) GeriCare, Distributed by: Gericare Pharmaceuticals Corp., 1650 63rd St., Brooklyn, NY 11204, UPC 3 57896 18405 6, NDC 57896-181-05 Package NDCs: 49035-280-01; 49035-280-02; 49348-037-29; 41250-718-01; 57896-181-05 | CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line. | K.C. Pharmaceuticals, Inc / 397,430 bottles | Class II | Ongoing |
| D-0897-2023 | 06-13-2023 | Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formula Eye Drops, DG health, DISTRIBUTED BY OLD EAST MAIN CO, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; b) Publix, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 01076 5; c) sterile eye drops, Original Formula, sunmark, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 10939 16733 0, NDC 49348-037-29; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; e) Eye Drops, Original Formula, GoodSense, Distributed By: Geiss, Destin & Dunn, Inc., Peachtree City, GA 30269, UPC 1 80410 00015 6, NDC 50804-141-01; f) sterile eye drops, Circle K, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404 Proudly distributed by Circle K Stores Inc., UPC 1 94283 65185 8; g) Sterile Eye Drops, Regular Formula, Lil Drug Store, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404; UPC 3 66715 68324 3; h) Tetrahydrozoline Ophthalmic Solution, Rugby, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, UPC 3 05361 21794 5, NDC 0536-1217-94, i) Leader, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, UPC 0 96295 13645 6, NDC 70000-0454-1; j) REDNESS RELIEF EYE DROPS, CAREone, Distributed by: FOODHOLD USA, LLC, LANDOVER, MD 20785; UPC 0 41520 86531 1, NDC 41520-431-05; k) Eye Drops, Original Formula, Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, UPC 0 87701 14975 7, NDC 24385-075-05; l) Eye Drops, ORIGINAL FORMULA, Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, UPC 3 11917 20076 7; m) CVS Health, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 36131 3; n) H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; o) redness relief, Original Redness Reliever Eye Drops, meijer, DIST. BY MEIJER DISTRIBUTION INC., GRAND RAPIDS, MI 49544, UPC 0 41250 82916 4, NDC 41250-814-01; p) Eye Drops, ORIGINAL, Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47011 3 Package NDCs: 49348-037-29; 50804-141-01; 41250-814-01; 0536-1217-94; 70000-0454-1; 41520-431-05; 24385-075-05 | CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line. | K.C. Pharmaceuticals, Inc / 341,568 bottles | Class II | Ongoing |
| D-0871-2023 | 06-12-2023 | Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30 Package NDCs: 69918-301-30 | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | Amring Pharmaceuticals Inc / 48,989 bottles | Class III | Terminated |
| D-0879-2023 | 06-12-2023 | Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ NDC# 55566-6500-03 | cGMP deviations: potential for Microbial Contamination of Non-Sterile Products | Ferring Pharmaceuticals Inc / N/A | Class II | Terminated |
| D-0870-2023 | 06-06-2023 | GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3 Package NDCs: 51662-1487-1; 51662-1487-2; 51662-1487-3 | Labeling: Label Mix-up | HF Acquisition Co LLC / 9 boxes of 25 vials | Class III | Terminated |
| D-0888-2023 | 06-05-2023 | StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02 | cGMP deviations | Homeocare Laboratories, Inc. / 40,034/1 fl. oz tubes | Class II | Terminated |
| D-0881-2023 | 06-05-2023 | Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6 | cGMP deviations | Homeocare Laboratories, Inc. / 2,376 bottles | Class II | Terminated |
| D-0883-2023 | 06-05-2023 | Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01 | cGMP deviations | Homeocare Laboratories, Inc. / 5957 bottles | Class II | Terminated |
| D-0886-2023 | 06-05-2023 | StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16 Package NDCs: 69685-103-16 | cGMP deviations | Homeocare Laboratories, Inc. / 130,762/16 oz. tottles | Class II | Terminated |
| D-0885-2023 | 06-05-2023 | SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99 | cGMP deviations | Homeocare Laboratories, Inc. / 200 liters/55 gallon drum | Class II | Terminated |
| D-0889-2023 | 06-05-2023 | StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02 | cGMP deviations | Homeocare Laboratories, Inc. / 38,105/1 fl. oz. tubes | Class II | Terminated |
| D-0884-2023 | 06-05-2023 | DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15 | cGMP deviations | Homeocare Laboratories, Inc. / 12,850 tottles | Class II | Terminated |
| D-0882-2023 | 06-05-2023 | Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01 | cGMP deviations | Homeocare Laboratories, Inc. / 5,956 bottles | Class II | Terminated |
| D-0880-2023 | 06-05-2023 | Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02 | cGMP deviations | Homeocare Laboratories, Inc. / 921 bottles | Class II | Terminated |
| D-0890-2023 | 06-05-2023 | StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01 Package NDCs: 69685-112-01; 69685-115-01; 69685-111-01 | cGMP deviations | Homeocare Laboratories, Inc. / 33,109/1 fl. oz. tubes | Class II | Terminated |
| D-0887-2023 | 06-05-2023 | StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16 Package NDCs: 69685-113-16 | cGMP deviations | Homeocare Laboratories, Inc. / 16,587 bottles | Class II | Terminated |
| D-0893-2023 | 05-31-2023 | ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6269-08 Package NDCs: 0904-6269-08; 0904-6269-45; 0904-6270-08; 0904-6270-45; 0904-6271-08; 0904-6271-45; 0904-6272-08; 0904-6272-45 | Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / unknown | Class I | Terminated |
| D-0876-2023 | 05-30-2023 | Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per 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: Out-of-specification results for dissolution (above specification) | Amneal Pharmaceuticals of New York, LLC / 9,056 bottles | Class II | Terminated |
| D-0891-2023 | 05-30-2023 | Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti, Halol-389350, Gujarat, India, NDC 62756-0233-01 | Subpotent drug | SUN PHARMACEUTICAL INDUSTRIES INC / 12960 vials | Class II | Terminated |
| D-0867-2023 | 05-25-2023 | Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactured by: GSMS Incorporated, Camarillo, CA 93012, a) NDC 51407-731-25 (2.5 mL bottle), b) NDC 51407-731-05 (5 mL bottle). Package NDCs: 51407-731-25; 51407-731-05 | Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container. | Golden State Medical Supply Inc. / 1,920 bottles | Class II | Terminated |
| D-0866-2023 | 05-25-2023 | Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05 | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess. | Viatris Inc / 2,736 boxes | Class II | Terminated |
| D-0777-2023 | 05-23-2023 | Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10 Package NDCs: 49230-300-10 | Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. | Fresenius Medical Care Holdings, Inc. / 53,424 bags | Class II | Terminated |
| D-0778-2023 | 05-22-2023 | Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25 | Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride | New England Life Care, Inc. dba Advanced Compounding Solutions / 198 | Class III | Terminated |
| D-0765-2023 | 05-22-2023 | Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35. Package NDCs: 0363-9947-29; 0363-9947-35; 0363-9947-40 | Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity. | Aurobindo Pharma USA Inc. / 87,360 bottles | Class II | Completed |
| D-0763-2023 | 05-19-2023 | Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10 | Lack of Assurance of Sterility | Sagent Pharmaceuticals Inc / 2,249,980 vials | Class II | Ongoing |
| D-0764-2023 | 05-19-2023 | Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99 | Lack of Assurance of Sterility | Sagent Pharmaceuticals Inc / 370,200 bottles | Class II | Ongoing |
| D-0762-2023 | 05-19-2023 | Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10 | Lack of Assurance of Sterility | Sagent Pharmaceuticals Inc / 2,249,980 vials | Class II | Ongoing |
| D-0877-2023 | 05-18-2023 | Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01 Package NDCs: 13107-014-01; 13107-015-01 | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC / | Class III | Terminated |
| D-0760-2023 | 05-16-2023 | FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park, Pittsburgh, PA 15238, | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. | Alpha Aromatics / 544 1 gallon bottles | Class II | Terminated |
| D-0619-2023 | 05-15-2023 | Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-097-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 243,825 vials | Class II | Terminated |
| D-0618-2023 | 05-15-2023 | Ceftriaxone for Injection, USP, 1 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-096-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 739,750 vials | Class II | Terminated |
| D-0584-2023 | 05-15-2023 | Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-224-15 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 8,925 bottles | Class II | Terminated |
| D-0582-2023 | 05-15-2023 | Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-222-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 89,690 vials | Class II | Terminated |
| D-0625-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-004-51 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 249,080 vials | Class II | Terminated |
| D-0626-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC66794-216-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 112,640 vials | Class II | Terminated |
| D-0608-2023 | 05-15-2023 | Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-210-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 51,280 vials | Class II | Terminated |
| D-0607-2023 | 05-15-2023 | Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-209-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 41,320 vials | Class II | Terminated |
| D-0611-2023 | 05-15-2023 | Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-211-42 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 66,250 vials | Class II | Terminated |
| D-0591-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-022-10 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 419,680 vials | Class II | Terminated |
| D-0615-2023 | 05-15-2023 | Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-215-15 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 9,040 bottles | Class II | Terminated |
| D-0600-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-242-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 91,860 vials | Class II | Terminated |
| D-0595-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-206-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 357,550 vials | Class II | Terminated |
| D-0612-2023 | 05-15-2023 | Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-212-42 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 65,950 vials | Class II | Terminated |
| D-0623-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-002-31 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 110,660 vials | Class II | Terminated |
| D-0628-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-218-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 138,610 vials | Class II | Terminated |
| D-0605-2023 | 05-15-2023 | Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-058-10 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 124,010 vials | Class II | Terminated |
| D-0606-2023 | 05-15-2023 | Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-009-20 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 107,320 vials | Class II | Terminated |
| D-0583-2023 | 05-15-2023 | Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 45,160 vials | Class II | Terminated |
| D-0604-2023 | 05-15-2023 | Cefepime for Injection, USP 1 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-057-10 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 101,550 vials | Class II | Terminated |
| D-0599-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-243-15 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 6,127 bottles | Class II | Terminated |
| D-0598-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-208-15 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 11,555 bottles | Class II | Terminated |
| D-0621-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-576-10 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 1,288,510 vials | Class II | Terminated |
| D-0597-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-207-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 1,001,110 vials | Class II | Terminated |
| D-0580-2023 | 05-15-2023 | Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-220-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 70,040 vials | Class II | Terminated |
| D-0581-2023 | 05-15-2023 | Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-221-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 17,350 vials | Class II | Terminated |
| D-0590-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-021-10 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 59,040 vials | Class II | Terminated |
| D-0613-2023 | 05-15-2023 | Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-213-42 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 73,475 vials | Class II | Terminated |
| D-0622-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-577-10 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 204,860 vials | Class II | Terminated |
| D-0614-2023 | 05-15-2023 | Ceftriaxone for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-214-42 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 41,500 vials | Class II | Terminated |
| D-0624-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-003-31 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 893,950 vials | Class II | Terminated |
| D-0627-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-217-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 223,590 vials | Class II | Terminated |
| D-0596-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-241-41 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 58,770 vials | Class II | Terminated |
| D-0587-2023 | 05-15-2023 | Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-086-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 80,850 vials | Class II | Terminated |
| D-0585-2023 | 05-15-2023 | Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-084-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 53,220 vials | Class II | Terminated |
| D-0631-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-080-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 393,930 vials | Class II | Terminated |
| D-0610-2023 | 05-15-2023 | Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-090-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 964,420 vials | Class II | Terminated |
| D-0588-2023 | 05-15-2023 | Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-087-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 220,340 vials | Class II | Terminated |
| D-0592-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 236,610 vials | Class II | Terminated |
| D-0593-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-006-30 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 1,229,090 vials | Class II | Terminated |
| D-0617-2023 | 05-15-2023 | Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-095-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 66,175 vials | Class II | Terminated |
| D-0609-2023 | 05-15-2023 | Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-089-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 550,160 vials | Class II | Terminated |
| D-0630-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, UPS, 3.375 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-079-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 936,680 vials | Class II | Terminated |
| D-0601-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-081-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 119,340 vials | Class II | Terminated |
| D-0586-2023 | 05-15-2023 | Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-085-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 59,530 vials | Class II | Terminated |
| D-0603-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-083-01 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 23,187 bottles | Class II | Terminated |
| D-0629-2023 | 05-15-2023 | Piperacillin and Tazobactam for Injection, USP 2.25 g per vial,s Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-078-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 169,520 Vials | Class II | Terminated |
| D-0602-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-082-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 591,160 vials | Class II | Terminated |
| D-0620-2023 | 05-15-2023 | Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-098-01 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 7,940 bottles | Class II | Terminated |
| D-0594-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-007-75 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 35,087 bottles | Class II | Terminated |
| D-0616-2023 | 05-15-2023 | Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-094-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 66,125 vials | Class II | Terminated |
| D-0589-2023 | 05-15-2023 | Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-088-01 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 7,214 bottles | Class II | Terminated |
| D-0865-2023 | 05-12-2023 | ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W Sam Houston Pkwy N Ste 300 Houston, TX 77041, NDC 72627-2405-1 | Mislabeling: preservative free product labeled as preserved. | Empower Clinic Services LLC dba Empower Pharmacy / 504 vials | Class II | Completed |
| D-0574-2023 | 05-11-2023 | Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724. Package NDCs: 0641-6044-01; 0641-6044-25; 0641-6046-01; 0641-6046-10; 0641-6045-01; 0641-6045-25; 0641-6047-01; 0641-6047-10 | Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C. | Hikma Pharmaceuticals USA Inc. / 1,352,475 vials | Class II | Terminated |
| D-0771-2023 | 05-11-2023 | Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64. | Sub-potent Drug | Revive Rx LLC dba Revive Rx Pharmacy / 45 Vials | Class II | Ongoing |
| D-0776-2023 | 05-09-2023 | HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2 | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / 3,232 syringes | Class II | Ongoing |
| D-0579-2023 | 05-09-2023 | Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20, Package NDCs: 0264-9567-10; 0264-9577-10; 0264-9587-20 | Subpotent: Low anti-factor IIa Potency. | B. Braun Medical Inc / 1,380 | Class II | Terminated |
| D-0761-2023 | 05-09-2023 | buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86 Package NDCs: 47335-736-86; 47335-736-88; 47335-736-08; 47335-736-13; 47335-737-86; 47335-737-88; 47335-737-08; 47335-737-13; 47335-738-86; 47335-738-88; 47335-738-08; 47335-738-13 | Failed Dissolution Specifications; during stability testing | SUN PHARMACEUTICAL INDUSTRIES INC / 5,344 Bottles | Class II | Terminated |
| D-0756-2023 | 05-08-2023 | Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal Pharamceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1574-01. | Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1. | Amneal Pharmaceuticals of New York, LLC / 69,239 vials | Class III | Terminated |
| D-0775-2023 | 05-03-2023 | Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807. | CGMP Deviations: Use of non-food grade lubricant in mixing vessel. | Denison Pharmaceuticals, LLC / 13,968 bottles | Class II | Ongoing |
