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-0382-2025 | 04-15-2025 | Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-403-02 | cGMP deviations | Pharmadel, LLC / 6,048 bottles | Class II | Terminated |
| D-0409-2025 | 04-15-2025 | FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25 | Lack of Assurance of Sterility | Apollo Care, LLC / 440 bags | Class II | Ongoing |
| D-0464-2025 | 04-14-2025 | MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3. | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. | SAINI TRADE INC / 500 boxes | Class I | Ongoing |
| D-0465-2025 | 04-14-2025 | ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J. | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil. | SAINI TRADE INC / 300 boxes | Class I | Ongoing |
| D-0466-2025 | 04-14-2025 | ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9. | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. | SAINI TRADE INC / 500 boxes | Class I | Ongoing |
| D-0387-2025 | 04-14-2025 | Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10 Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Breckenridge Pharmaceutical, Inc / 16,473 bottles | Class II | Ongoing |
| D-0388-2025 | 04-14-2025 | Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922 Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Breckenridge Pharmaceutical, Inc / 343,344 bottles | Class II | Ongoing |
| D-0463-2025 | 04-14-2025 | Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG. | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. | SAINI TRADE INC / 3000 boxes | Class I | Ongoing |
| D-0467-2025 | 04-14-2025 | Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH. | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. | SAINI TRADE INC / 300 boxes | Class I | Ongoing |
| D-0366-2025 | 04-14-2025 | ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61 | CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 133 cartons | Class II | Ongoing |
| D-0377-2025 | 04-10-2025 | clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01 Package NDCs: 68180-492-01; 68180-492-07; 68180-492-09; 68180-492-06; 68180-493-01; 68180-493-07; 68180-493-09; 68180-493-06; 68180-494-01; 68180-494-07; 68180-494-09; 68180-494-06 | Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study. | Lupin Pharmaceuticals Inc. / 2724 bottles | Class II | Terminated |
| D-0395-2025 | 04-10-2025 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-448-17. Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent | ACCORD HEALTHCARE, INC. / 4,872 Bottles | Class II | Ongoing |
| D-0396-2025 | 04-10-2025 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-450-17 Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent | ACCORD HEALTHCARE, INC. / 4,885 Bottles | Class II | Ongoing |
| D-0397-2025 | 04-10-2025 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-452-15 Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent | ACCORD HEALTHCARE, INC. / 18,984 Bottles | Class II | Ongoing |
| D-0394-2025 | 04-10-2025 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17 Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent | ACCORD HEALTHCARE, INC. / 4,888 Bottles | Class II | Ongoing |
| D-0363-2025 | 04-10-2025 | Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01 Package NDCs: 55150-276-01; 55150-277-01; 55150-278-01 | cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. | Eugia US LLC / 36,816 vials | Class II | Ongoing |
| D-0393-2025 | 04-09-2025 | Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14. | Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released. | Cardinal Health Inc. / 48 Cartons | Class II | Ongoing |
| D-0375-2025 | 04-09-2025 | Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318 | CGMP Deviations | Apipharma / 4,218 boxes | Class II | Ongoing |
| D-0376-2025 | 04-09-2025 | Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10090 Zagreb, Croatia, Distributed by: Apipharma, LLC, 2331 West Alameda Drive, Tempe, AZ 85282 UPC 3 858882 101363 | CGMP Deviations | Apipharma / 5,095 cartons | Class II | Ongoing |
| D-0361-2025 | 04-03-2025 | chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1 Package NDCs: 70710-1129-1; 70710-1129-2; 70710-1129-4; 70710-1130-1; 70710-1130-2; 70710-1130-4; 70710-1131-1; 70710-1131-2; 70710-1131-4; 70710-1132-1; 70710-1132-2; 70710-1132-4; 70710-1133-1; 70710-1133-2; 70710-1133-4 | CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit | Zydus Pharmaceuticals (USA) Inc / 3144 bottles, pack size: 100's Count | Class II | Ongoing |
| D-0367-2025 | 04-02-2025 | Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41. Package NDCs: 68001-579-59; 68001-579-48; 68001-580-41; 68001-581-41; 68001-581-48; 68001-581-82; 68001-578-59; 68001-578-48; 68001-582-41 | Lack of assurance of sterility. Bacterial contamination detected in some media fill units | Amerisource Health Services LLC / 2,110 vials | Class II | Ongoing |
| D-0368-2025 | 04-02-2025 | Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41. Package NDCs: 68001-579-59; 68001-579-48; 68001-580-41; 68001-581-41; 68001-581-48; 68001-581-82; 68001-578-59; 68001-578-48; 68001-582-41 | Lack of assurance of sterility. Bacterial contamination detected in some media fill units | Amerisource Health Services LLC / 14,189 vials | Class II | Ongoing |
| D-0369-2025 | 04-02-2025 | Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48. Package NDCs: 68001-579-59; 68001-579-48; 68001-580-41; 68001-581-41; 68001-581-48; 68001-581-82; 68001-578-59; 68001-578-48; 68001-582-41 | Lack of assurance of sterility. Bacterial contamination detected in some media fill units | Amerisource Health Services LLC / 143 1x5 vials | Class II | Ongoing |
| D-0374-2025 | 03-31-2025 | Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11 | Lack of Assurance of Sterility: Leaking/damaged syringes. | Denver Solutions, LLC DBA Leiters Health / 16,655 syringes | Class II | Ongoing |
| D-0372-2025 | 03-31-2025 | PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11, | Lack of Assurance of Sterility: Leaking/damaged syringes. | Denver Solutions, LLC DBA Leiters Health / 7,290 syringes | Class II | Ongoing |
| D-0370-2025 | 03-31-2025 | Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11 | Lack of Assurance of Sterility: Leaking/damaged syringes. | Denver Solutions, LLC DBA Leiters Health / 170 syringes | Class II | Ongoing |
| D-0371-2025 | 03-31-2025 | dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11. | Lack of Assurance of Sterility: Leaking/damaged syringes. | Denver Solutions, LLC DBA Leiters Health / 23,610 syringes | Class II | Ongoing |
| D-0373-2025 | 03-31-2025 | Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11 | Lack of Assurance of Sterility: Leaking/damaged syringes. | Denver Solutions, LLC DBA Leiters Health / 49,830 syringes | Class II | Ongoing |
| D-0353-2025 | 03-31-2025 | 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10 Package NDCs: 0264-2201-00; 0264-2201-10; 0264-2201-50; 0264-2201-70 | Presence of Particulate Matter | B. Braun Medical Inc / 32,256 Bottles | Class II | Ongoing |
| D-0386-2025 | 03-31-2025 | Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY | CGMP Deviations | Medisca Inc. / 161.6 grams | Class II | Terminated |
| D-0308-2025 | 03-26-2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10. Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit. | Breckenridge Pharmaceutical, Inc. / 14,863 bottles | Class II | Ongoing |
| D-0362-2025 | 03-26-2025 | Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2 | CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit | Chattem Inc / 129,240 bottles | Class II | Ongoing |
| D-0378-2025 | 03-24-2025 | Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00 | CGMP Deviations | RemedyRepack Inc. / 1,858 30-count blister cards | Class II | Ongoing |
| D-0307-2025 | 03-24-2025 | Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-294-21, Unit Dose NDC 60687-294-11. Package NDCs: 60687-294-11; 60687-294-21; 60687-273-11; 60687-273-21 | cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product. | Amerisource Health Services LLC / 889 cartons | Class II | Terminated |
| D-0310-2025 | 03-21-2025 | Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01. Package NDCs: 68382-018-06; 68382-018-14; 68382-018-16; 68382-018-01; 68382-018-05; 68382-018-10; 68382-019-06; 68382-019-14; 68382-019-16; 68382-019-01; 68382-019-05; 68382-019-10; 68382-020-06; 68382-020-14; 68382-020-16; 68382-020-01; 68382-020-05; 68382-020-10; 68382-021-06; 68382-021-14; 68382-021-16; 68382-021-01; 68382-021-05; 68382-021-10; 68382-101-06; 68382-101-14; 68382-101-16; 68382-101-01; 68382-101-05; 68382-101-10 | Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet. | Zydus Pharmaceuticals (USA) Inc / 13,128 100-Count Bottles | Class II | Completed |
| D-0356-2025 | 03-21-2025 | Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41 Package NDCs: 68001-579-59; 68001-579-48; 68001-580-41; 68001-581-41; 68001-581-48; 68001-581-82; 68001-578-59; 68001-578-48; 68001-582-41 | Lack of Assurance of Sterility: Media fill with bacterial contamination | Somerset Therapeutics Private Limited / 4956 vials | Class II | Ongoing |
| D-0354-2025 | 03-21-2025 | Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton) Package NDCs: 70069-101-25; 70069-101-10; 70069-101-05 | Lack of Assurance of Sterility: Media fill with bacterial contamination | Somerset Therapeutics Private Limited / 506,080 vials | Class II | Ongoing |
| D-0358-2025 | 03-21-2025 | Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10 Package NDCs: 70069-030-05; 70069-030-03; 70069-031-01; 70069-031-05; 70069-381-01; 70069-381-10; 70069-382-01; 70069-382-05; 70069-383-05; 70069-383-10; 70069-383-01; 70069-384-01; 70069-384-05 | Lack of Assurance of Sterility: Media fill with bacterial contamination | Somerset Therapeutics Private Limited / 240 vials | Class II | Ongoing |
| D-0355-2025 | 03-21-2025 | Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton) Package NDCs: 70069-030-05; 70069-030-03; 70069-031-01; 70069-031-05; 70069-381-01; 70069-381-10; 70069-382-01; 70069-382-05; 70069-383-05; 70069-383-10; 70069-383-01; 70069-384-01; 70069-384-05 | Lack of Assurance of Sterility: Media fill with bacterial contamination | Somerset Therapeutics Private Limited / 997 vials | Class II | Ongoing |
| D-0357-2025 | 03-21-2025 | Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons) Package NDCs: 68001-579-59; 68001-579-48; 68001-580-41; 68001-581-41; 68001-581-48; 68001-581-82; 68001-578-59; 68001-578-48; 68001-582-41 | Lack of Assurance of Sterility: Media fill with bacterial contamination | Somerset Therapeutics Private Limited / 23,960 vials | Class II | Ongoing |
| D-0306-2025 | 03-17-2025 | Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13 Package NDCs: 70377-077-11; 70377-077-13; 70377-077-12; 70377-078-11; 70377-078-13; 70377-078-12; 70377-079-11; 70377-079-12; 70377-079-13; 70377-080-11; 70377-080-12; 70377-080-13 | Failed dissolution specifications: lower than specifications | BIOCON PHARMA INC / 2184 bottles | Class II | Ongoing |
| D-0325-2025 | 03-13-2025 | Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-198-90. Package NDCs: 68462-195-90; 68462-195-05; 68462-196-90; 68462-196-05; 68462-197-90; 68462-197-05; 68462-198-90; 68462-198-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0341-2025 | 03-13-2025 | Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. Package NDCs: 68462-195-90; 68462-195-05; 68462-196-90; 68462-196-05; 68462-197-90; 68462-197-05; 68462-198-90; 68462-198-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0330-2025 | 03-13-2025 | Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-679-60 Package NDCs: 68462-678-30; 68462-678-60; 68462-678-10; 68462-679-30; 68462-679-60; 68462-679-10; 68462-680-30; 68462-680-60; 68462-680-10; 68462-681-30; 68462-681-60; 68462-681-10 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0352-2025 | 03-13-2025 | Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-826-01 Package NDCs: 16714-825-01; 16714-826-01; 16714-827-01 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0339-2025 | 03-13-2025 | Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-264-30 Package NDCs: 68462-261-30; 68462-261-50; 68462-261-90; 68462-261-01; 68462-261-10; 68462-261-11; 68462-262-30; 68462-262-50; 68462-262-90; 68462-262-01; 68462-262-10; 68462-262-11; 68462-263-30; 68462-263-50; 68462-263-90; 68462-263-01; 68462-263-10; 68462-263-11; 68462-264-30; 68462-264-50; 68462-264-90; 68462-264-01; 68462-264-05; 68462-264-10 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0348-2025 | 03-13-2025 | Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35 Package NDCs: 72657-128-30; 72657-128-45; 72657-128-60; 72657-128-70; 72657-128-90; 72657-128-08; 72657-128-14; 72657-128-15; 72657-128-18; 72657-128-24; 72657-128-03; 72657-128-35; 72657-128-04; 72657-128-81; 72657-128-82; 72657-128-84; 72657-128-86; 72657-128-41; 72657-129-30; 72657-129-45; 72657-129-60; 72657-129-70; 72657-129-90; 72657-129-08; 72657-129-14; 72657-129-15; 72657-129-18; 72657-129-24; 72657-129-03; 72657-129-35; 72657-129-04; 72657-129-81; 72657-129-82; 72657-129-84; 72657-129-86; 72657-129-41; 72657-130-05; 72657-131-89 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0347-2025 | 03-13-2025 | Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India Package NDCs: 72657-157-18; 72657-157-36; 72657-157-72; 72657-157-74; 72657-157-76; 72657-157-20; 72657-157-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0322-2025 | 03-13-2025 | Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-694-97 Package NDCs: 68462-694-97 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0340-2025 | 03-13-2025 | Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-433-18 Package NDCs: 68462-433-90; 68462-433-18 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0345-2025 | 03-13-2025 | Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. Package NDCs: 68462-726-30; 68462-726-90; 68462-726-05; 68462-727-30; 68462-727-90; 68462-727-05; 68462-727-14 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0328-2025 | 03-13-2025 | Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC 68462-521-90. Package NDCs: 68462-520-01; 68462-520-05; 68462-520-10; 68462-521-90; 68462-521-01; 68462-521-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0332-2025 | 03-13-2025 | Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. Package NDCs: 68462-726-30; 68462-726-90; 68462-726-05; 68462-727-30; 68462-727-90; 68462-727-05; 68462-727-14 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0326-2025 | 03-13-2025 | Fluphenazine Hydrochloride Tablets, 10mg, 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# 68462-338-01 Package NDCs: 68462-914-01; 68462-914-05; 68462-914-14; 68462-336-01; 68462-336-05; 68462-336-14; 68462-337-01; 68462-337-05; 68462-337-14; 68462-338-01; 68462-338-05; 68462-338-14 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0323-2025 | 03-13-2025 | Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-713-08 Package NDCs: 68462-713-30; 68462-713-08; 68462-713-05; 68462-714-08; 68462-714-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0336-2025 | 03-13-2025 | Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 NDC# 68462-164-05. Package NDCs: 68462-162-60; 68462-162-01; 68462-162-18; 68462-162-05; 68462-162-10; 68462-163-60; 68462-163-01; 68462-163-18; 68462-163-05; 68462-163-10; 68462-164-60; 68462-164-01; 68462-164-18; 68462-164-05; 68462-164-10; 68462-165-60; 68462-165-01; 68462-165-18; 68462-165-05; 68462-165-10 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0349-2025 | 03-13-2025 | Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-559-01 Package NDCs: 16714-558-01; 16714-558-02; 16714-559-01; 16714-559-02; 16714-560-01; 16714-560-02; 16714-570-01; 16714-570-02 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0365-2025 | 03-13-2025 | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, - 500 043 INDIA, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-636-52 Package NDCs: 43598-635-52; 43598-635-10; 43598-636-52; 43598-636-10; 43598-637-52; 43598-637-10 | LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL. | Dr. Reddy's Laboratories, Inc. / 4,010 bags | Class I | Ongoing |
| D-0329-2025 | 03-13-2025 | Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-325-60 Package NDCs: 68462-325-60; 68462-325-90; 68462-325-01; 68462-325-05; 68462-325-10 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0327-2025 | 03-13-2025 | Fluphenazine Hydrochloride Tablets 2.5mg, 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# 68462-336-01 Package NDCs: 68462-914-01; 68462-914-05; 68462-914-14; 68462-336-01; 68462-336-05; 68462-336-14; 68462-337-01; 68462-337-05; 68462-337-14; 68462-338-01; 68462-338-05; 68462-338-14 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0331-2025 | 03-13-2025 | Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-638-01 Package NDCs: 68462-638-01; 68462-639-01; 68462-639-25; 68462-639-45; 68462-640-01 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0342-2025 | 03-13-2025 | Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 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# 68462-562-01 Package NDCs: 68462-850-01; 68462-851-01; 68462-562-01 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0317-2025 | 03-13-2025 | Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. Package NDCs: 68462-386-30; 68462-386-90; 68462-386-14; 68462-387-30; 68462-387-90; 68462-387-14 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0314-2025 | 03-13-2025 | Fenofibrate Capsules 67 mg, USP, 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# 68462-580-01 Package NDCs: 68462-580-01; 68462-581-01; 68462-582-01 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0344-2025 | 03-13-2025 | Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-144-01 Package NDCs: 68462-142-01; 68462-143-01; 68462-143-05; 68462-144-01; 68462-144-81 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0316-2025 | 03-13-2025 | Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-409-60 Package NDCs: 68462-408-60; 68462-409-60; 68462-410-60 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0315-2025 | 03-13-2025 | Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-408-60 Package NDCs: 68462-408-60; 68462-409-60; 68462-410-60 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0346-2025 | 03-13-2025 | Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-179-01 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 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0351-2025 | 03-13-2025 | Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-825-01. Package NDCs: 16714-825-01; 16714-826-01; 16714-827-01 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0324-2025 | 03-13-2025 | Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-639-45. Package NDCs: 68462-638-01; 68462-639-01; 68462-639-25; 68462-639-45; 68462-640-01 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0343-2025 | 03-13-2025 | Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-680-60. Package NDCs: 68462-678-30; 68462-678-60; 68462-678-10; 68462-679-30; 68462-679-60; 68462-679-10; 68462-680-30; 68462-680-60; 68462-680-10; 68462-681-30; 68462-681-60; 68462-681-10 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0321-2025 | 03-13-2025 | Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-681-60. Package NDCs: 68462-678-30; 68462-678-60; 68462-678-10; 68462-679-30; 68462-679-60; 68462-679-10; 68462-680-30; 68462-680-60; 68462-680-10; 68462-681-30; 68462-681-60; 68462-681-10 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0337-2025 | 03-13-2025 | Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-678-60 Package NDCs: 68462-678-30; 68462-678-60; 68462-678-10; 68462-679-30; 68462-679-60; 68462-679-10; 68462-680-30; 68462-680-60; 68462-680-10; 68462-681-30; 68462-681-60; 68462-681-10 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0338-2025 | 03-13-2025 | Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-890-01 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0319-2025 | 03-13-2025 | Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-572-30. Package NDCs: 68462-572-30; 68462-572-90; 68462-572-13; 68462-573-30; 68462-573-90; 68462-573-13 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0320-2025 | 03-13-2025 | Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05. Package NDCs: 68462-126-01; 68462-126-05; 68462-127-01; 68462-127-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0350-2025 | 03-13-2025 | Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India Package NDCs: 16714-558-01; 16714-558-02; 16714-559-01; 16714-559-02; 16714-560-01; 16714-560-02; 16714-570-01; 16714-570-02 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0334-2025 | 03-13-2025 | Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-424-30 Package NDCs: 68462-423-15; 68462-423-85; 68462-423-30; 68462-424-15; 68462-424-85; 68462-424-30 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0335-2025 | 03-13-2025 | Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-320-60 Package NDCs: 68462-319-60; 68462-319-05; 68462-320-60; 68462-320-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0333-2025 | 03-13-2025 | Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. Package NDCs: 68462-386-30; 68462-386-90; 68462-386-14; 68462-387-30; 68462-387-90; 68462-387-14 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0318-2025 | 03-13-2025 | Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-573-30 Package NDCs: 68462-572-30; 68462-572-90; 68462-572-13; 68462-573-30; 68462-573-90; 68462-573-13 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / N/A | Class II | Ongoing |
| D-0512-2025 | 03-12-2025 | B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1002-2; b) Tint Free Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1001-2; c) Tan Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1003-2. | cGMP deviations | KABANA SKIN CARE / 204 tubes | Class II | Ongoing |
| D-0514-2025 | 03-12-2025 | GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free, Biodegradable, Chemical Free, Non-Nano, Baby Safe, Original, SPF 32, Totally Green personal care, Zinc Oxide USP 25%, 3.4 FL OZ/115 G Tube, NDC: 73369-0001-1 | cGMP deviations | KABANA SKIN CARE / 174 tubes | Class II | Ongoing |
| D-0515-2025 | 03-12-2025 | In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free, Organic Ingredients, Biodegradable & Baby Safe, 50 mL - 1.7 fl oz per bottle, Manufactured for IN YOUR FACE Skin Care, Belleair Bluffs, FL, Made in USA, NDC: 73369-1601-1 | cGMP deviations | KABANA SKIN CARE / 76 bottles | Class II | Ongoing |
| D-0513-2025 | 03-12-2025 | Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-1401-1 | cGMP deviations | KABANA SKIN CARE / 54 tubes | Class II | Ongoing |
| D-0360-2025 | 03-12-2025 | Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 fl. oz. (177.4 mL), UPC 7 35786 01528 2; b) 0.33 OZ (9.45g), UPC 8 42944 10223 1; Distributed by Alchemee, LLC, Santa Monica, CA 90401, | Chemical contamination: Presence of benzene | Alchemee, LLC / 3,500 bottles | Class II | Ongoing |
| D-0359-2025 | 03-12-2025 | Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), Distributed by Alchemee LLC, Santa Monica, CA 90401, Made in the USA, UPC 7 35786 01921 1, UPC 8 42944 10223 1, and also packaged as a twin pack UPC 8 42944 10241 5, | Chemical contamination: Presence of benzene | Alchemee, LLC / 38,237 bottles | Class II | Ongoing |
| D-0284-2025 | 03-11-2025 | CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc | Chemical contamination: presence of benzene | Fruit Of The Earth, Inc. / 112045 tubes | Class II | Ongoing |
| D-0309-2025 | 03-11-2025 | chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01 Package NDCs: 68462-861-01; 68462-861-10; 68462-862-01; 68462-862-10; 68462-863-01; 68462-863-10; 68462-864-01; 68462-864-10; 68462-865-01; 68462-865-10 | CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit. | Glenmark Pharmaceuticals Inc., USA / 8160 bottles | Class II | Ongoing |
| D-0282-2025 | 03-11-2025 | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05 Package NDCs: 69315-308-02; 69315-308-05; 69315-308-10 | Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle | FDC Limited / 90960 bottles | Class II | Ongoing |
| D-0283-2025 | 03-11-2025 | Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015 | Chemical contamination: presence of benzene | Fruit Of The Earth, Inc. / 100,970 tubes | Class II | Ongoing |
| D-0290-2025 | 03-07-2025 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20. Package NDCs: 51079-440-01; 51079-440-20; 51079-444-01; 51079-444-20; 51079-441-01; 51079-441-20; 51079-442-01; 51079-442-20; 51079-443-01; 51079-443-20; 51079-445-01; 51079-445-20 | Super-Potent Drug: Out of specification potency results were obtained. | Mylan Institutional, Inc. / 347 Cartons | Class II | Ongoing |
| D-0568-2025 | 03-07-2025 | Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Direct Rx / 875 bottles | Class II | Ongoing |
| D-0291-2025 | 03-07-2025 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20. Package NDCs: 51079-440-01; 51079-440-20; 51079-444-01; 51079-444-20; 51079-441-01; 51079-441-20; 51079-442-01; 51079-442-20; 51079-443-01; 51079-443-20; 51079-445-01; 51079-445-20 | Super-Potent Drug: Out of specification potency results were obtained. | Mylan Institutional, Inc. / 1,068 cartons | Class II | Ongoing |
| D-0302-2025 | 03-07-2025 | [CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INCORRECT BACK LABEL] Isopropyl alcohol 91%, Dist. by: Amazon.com Services, LLC, Seattle, WA 98109. Package NDCs: 0869-0871-72; 0869-0871-43; 0869-0871-45; 0869-0871-18; 0869-0871-99; 0869-0871-82 | Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol | Consumer Product Partners, LLC / 25,932 bottles | Class II | Ongoing |
| D-0313-2025 | 03-07-2025 | Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics LLC an affiliate of Gilead Sciences, Inc., Foster City, CA 94404, Made in Ireland, NDC# 72626-2701-1 Package NDCs: 72626-2701-1 | Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton. | ASEGUA THERAPEUTICS LLC / 18,541 cartons. | Class II | Ongoing |
| D-0279-2025 | 03-07-2025 | Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04 | CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. | Slate Run Pharmaceuticals / 2,444 bottles | Class II | Completed |
| D-0278-2025 | 03-07-2025 | Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04 | CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. | Slate Run Pharmaceuticals / 56,790 bottles | Class II | Completed |
| D-0303-2025 | 03-07-2025 | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4 Package NDCs: 51754-5001-5; 51754-5001-4; 51754-5011-4; 51754-5002-5; 51754-5012-4; 51754-5001-1 | Lack of Assurance of Sterility | Exela Pharma Sciences LLC / 103,950 vials | Class II | Ongoing |
| D-0567-2025 | 03-07-2025 | Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Direct Rx / 16 bottles | Class II | Ongoing |
