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 08, 2025 and include a total of 16999 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0237-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30. Package NDCs: 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 39,168 bottles | Class II | Ongoing |
| D-0235-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30. Package NDCs: 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 80,160 bottles | Class II | Ongoing |
| D-0244-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01. Package NDCs: 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 58,368 bottles | Class II | Ongoing |
| D-0240-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01. Package NDCs: 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 133,824 bottles | Class II | Ongoing |
| D-0232-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30. Package NDCs: 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 56,208 bottles | Class II | Ongoing |
| D-0238-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01. Package NDCs: 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 120,000 bottles | Class II | Ongoing |
| D-0241-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01. Package NDCs: 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 233,040 bottles | Class II | Ongoing |
| D-0239-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01. Package NDCs: 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 119,040 bottles | Class II | Ongoing |
| D-0236-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30. Package NDCs: 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 87,600 bottles | Class II | Ongoing |
| D-0242-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01. Package NDCs: 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 53,952 bottles | Class II | Ongoing |
| D-0231-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30. Package NDCs: 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 70,032 bottles | Class II | Ongoing |
| D-0234-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30. Package NDCs: 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 190,320 bottles | Class II | Ongoing |
| D-0233-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30. Package NDCs: 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 175,920 bottles | Class II | Ongoing |
| D-0299-2025 | 01-28-2025 | SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1 | Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus | Ascent Consumer Products Inc. / 4,176 cartons | Class I | Ongoing |
| D-0301-2025 | 01-28-2025 | SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00102 7 | Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus | Ascent Consumer Products Inc. / unknown | Class I | Ongoing |
| D-0300-2025 | 01-28-2025 | SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4 | Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus | Ascent Consumer Products Inc. / unknown | Class I | Ongoing |
| D-0217-2025 | 01-24-2025 | Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00. | CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit. | RemedyRepack Inc. / 247 blister packs | Class II | Terminated |
| D-0220-2025 | 01-24-2025 | HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10 Package NDCs: 63739-328-10; 0000127410; 0000127579; 0000128245; 0000128486 | Failed Impurities/Degradation Specifications | SKY PACKAGING / | Class II | Ongoing |
| D-0219-2025 | 01-24-2025 | HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10 Package NDCs: 63739-327-10; 0000127312; 0000127576; 0000127577; 0000128204; 0000128358 | Failed Impurities/Degradation Specifications | SKY PACKAGING / | Class II | Ongoing |
| D-0214-2025 | 01-23-2025 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05. Package NDCs: 64980-513-05; 64980-513-01; 64980-513-15; 64980-514-05; 64980-514-01; 64980-514-15 | 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 / 118104 bottles | Class II | Ongoing |
| D-0216-2025 | 01-22-2025 | Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ. 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:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / | Class II | Ongoing |
| D-0215-2025 | 01-22-2025 | Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ. 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:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / | Class II | Ongoing |
| D-0226-2025 | 01-21-2025 | Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61 Package NDCs: 0904-6007-60; 0904-6007-61; 0904-6008-60; 0904-6008-61; 0904-6009-60; 0904-6009-61 | Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 82,281 cartons | Class II | Ongoing |
| D-0230-2025 | 01-21-2025 | Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426 | Presence of Particulate Matter. | Provepharm Inc. / 24640 vials | Class I | Ongoing |
| D-0224-2025 | 01-21-2025 | Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15 Package NDCs: 50268-440-11; 50268-440-15; 50268-441-11; 50268-441-15; 50268-442-11; 50268-442-15 | Out of Specification for Dissolution | AvKARE / 341 cartons | Class II | Ongoing |
| D-0228-2025 | 01-21-2025 | Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61. Package NDCs: 0904-6007-60; 0904-6007-61; 0904-6008-60; 0904-6008-61; 0904-6009-60; 0904-6009-61 | Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 27,525 cartons | Class II | Ongoing |
| D-0227-2025 | 01-21-2025 | Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6008-61. Package NDCs: 0904-6007-60; 0904-6007-61; 0904-6008-60; 0904-6008-61; 0904-6009-60; 0904-6009-61 | Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 94,349 cartons | Class II | Ongoing |
| D-0213-2025 | 01-17-2025 | Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01 Package NDCs: 0069-0809-01 | cGMP Deviations: Product intended for quarantine was inadvertently distributed. | McKesson / 192 vials | Class II | Ongoing |
| D-0209-2025 | 01-17-2025 | BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2 | Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use. | The W.S. Badger Company, Inc. / 4,834 tins | Class III | Terminated |
| D-0208-2025 | 01-16-2025 | Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90. Package NDCs: 43598-943-30; 43598-943-90; 43598-944-30; 43598-944-90 | Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet | Appco Pharma LLC / 1380 bottles | Class III | Ongoing |
| D-0212-2025 | 01-13-2025 | Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA. Package NDCs: 0904-7043-04; 0904-7043-61; 0904-7044-61; 0904-7045-61 | CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / a) 6408 boxes and b)1488 boxes | Class II | Ongoing |
| D-0218-2025 | 01-10-2025 | Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only, Manufactured by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel. Package NDCs: 63459-910-01; 63459-910-12; 63459-910-11; 63459-910-15; 63459-910-18; 63459-910-17; 63459-910-36; 63459-912-01; 63459-912-12; 63459-912-11; 63459-912-15; 63459-912-18; 63459-912-17; 63459-912-36; 63459-918-53; 63459-918-59; 63459-920-53; 63459-920-59 | Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit | Teva Pharmaceuticals USA, Inc / 34,636 cartons | Class II | Ongoing |
| D-0298-2025 | 01-08-2025 | babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada. | Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed. | Johnson, S C and Son, Inc / 57,184 bottles | Class II | Ongoing |
| D-0222-2025 | 01-07-2025 | Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16 Package NDCs: 0121-0775-04; 0121-0775-08; 0121-0775-16; 0121-1775-05; 0121-1775-00; 0121-1775-10; 0121-1775-40; 0121-1550-10; 0121-1550-00; 0121-1550-40 | Superpotent; sodium benzoate preservative | PAI Holdings, LLC. dba Pharmaceutical Associates Inc / 4080 Bottles | Class III | Ongoing |
| D-0201-2025 | 01-07-2025 | Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11 Package NDCs: 60687-423-11; 60687-423-21 | Presence of Foreign Tablets/Capsules | Amerisource Health Services LLC / 4640 units | Class II | Ongoing |
| D-0188-2025 | 12-30-2024 | Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ Package NDCs: 57237-017-60; 57237-017-99; 57237-018-30; 57237-018-90; 57237-018-99; 57237-019-30; 57237-019-90; 57237-019-99 | CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Rising Pharma Holding, Inc. / 42,527 bottles | Class II | Ongoing |
| D-0189-2025 | 12-30-2024 | Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60 Package NDCs: 57237-017-60; 57237-017-99; 57237-018-30; 57237-018-90; 57237-018-99; 57237-019-30; 57237-019-90; 57237-019-99 | CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Rising Pharma Holding, Inc. / 73,680 bottles | Class II | Ongoing |
| D-0190-2025 | 12-30-2024 | Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ Package NDCs: 57237-017-60; 57237-017-99; 57237-018-30; 57237-018-90; 57237-018-99; 57237-019-30; 57237-019-90; 57237-019-99 | CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Rising Pharma Holding, Inc. / 244,460 bottles | Class II | Ongoing |
| D-0192-2025 | 12-30-2024 | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10 Package NDCs: 82009-117-10; 82009-118-01 | Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg. | Granules Pharmaceuticals Inc. / 6,804 bottles | Class II | Ongoing |
| D-0186-2025 | 12-27-2024 | Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10 Package NDCs: 55150-306-10 | Presence of Particulate Matter: A market complaint was received of a glass piece in the vial. | Eugia US LLC / 17,300 10-mL vials | Class II | Ongoing |
| D-0204-2025 | 12-23-2024 | Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93 Package NDCs: 58151-078-93; 58151-079-93 | Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing. | Viatris Inc / 6,605/30 count bottles | Class II | Ongoing |
| D-0210-2025 | 12-23-2024 | Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73. Package NDCs: 0469-0647-73; 0469-0647-11; 0469-0677-73; 0469-0677-11; 0469-0687-73; 0469-0687-11 | Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules | Astellas Pharma US Inc. / 3,500 30-count bottles | Class I | Ongoing |
| D-0203-2025 | 12-23-2024 | Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93 Package NDCs: 58151-078-93; 58151-079-93 | Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing. | Viatris Inc / 1,215/30 count bottles | Class II | Ongoing |
| D-0211-2025 | 12-23-2024 | Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73. Package NDCs: 0469-0607-73; 0469-0617-73; 0469-0617-11; 0469-0657-73; 0469-0657-11; 0469-3016-01; 0469-1230-50; 0469-1330-50 | Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules | Astellas Pharma US Inc. / 14,340 100-count bottles | Class I | Ongoing |
| D-0206-2025 | 12-23-2024 | First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6 | CGMP Deviations; product intended for quarantine was inadvertently distributed | First Aid Beauty Ltd / 2756 jars | Class II | Ongoing |
| D-0167-2025 | 12-20-2024 | Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03 Package NDCs: 68180-965-03; 68180-965-02; 68180-965-09; 68180-965-01; 68180-966-03; 68180-966-02; 68180-966-09; 68180-966-01; 68180-967-03; 68180-967-02; 68180-967-09; 68180-967-01; 68180-968-09; 68180-968-02; 68180-968-01; 68180-968-03; 68180-969-01; 68180-969-02; 68180-969-03; 68180-969-09; 68180-970-01; 68180-970-02; 68180-970-03; 68180-970-09; 68180-971-01; 68180-971-02; 68180-971-03; 68180-971-09; 68180-972-01; 68180-972-02; 68180-972-03; 68180-972-09; 68180-973-01; 68180-973-02; 68180-973-03; 68180-973-09; 68180-974-01; 68180-974-02; 68180-974-03; 68180-974-09; 68180-975-03; 68180-975-02; 68180-975-01; 68180-975-09; 68180-976-01; 68180-976-02; 68180-976-03; 68180-976-09 | Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study. | Lupin Pharmaceuticals Inc. / 480 1000-count bottles | Class II | Ongoing |
| D-0223-2025 | 12-20-2024 | Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01 | Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP) | ENDO USA, Inc. / 44,397 amber glass vials | Class I | Ongoing |
| D-0174-2025 | 12-19-2024 | phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25 | Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. | Hikma Injectables USA Inc / | Class II | Ongoing |
| D-0173-2025 | 12-19-2024 | ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25 | Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. | Hikma Injectables USA Inc / 1,800 syringes | Class II | Ongoing |
| D-0183-2025 | 12-19-2024 | Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20 Package NDCs: 0054-0709-25; 0054-0709-20; 0054-0710-25; 0054-0710-20 | Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only. | West-Ward Columbus Inc / 2591 100-count boxes | Class III | Ongoing |
| D-0185-2025 | 12-18-2024 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg per mL, Distributed by: Eugia US LLC, NJ, Manufactured by: Eugia Pharma Specialties Limited, India Package NDCs: 55150-329-01; 55150-329-25; 55150-330-01 | CGMP Deviations | Eugia US LLC / 19872 vials | Class II | Ongoing |
| D-0187-2025 | 12-18-2024 | Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03 Package NDCs: 70010-001-01; 70010-001-10; 70010-001-03 | Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles. | Granules Pharmaceuticals Inc. / 96 Bottles | Class II | Terminated |
| D-0176-2025 | 12-18-2024 | Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15 Package NDCs: 50268-678-15 | LABELING: LABEL MIX-UP | AvKARE / 0 | Class III | Ongoing |
| D-0175-2025 | 12-18-2024 | Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15. Package NDCs: 50268-068-15; 50268-068-02 | LABELING: LABEL MIX-UP | AvKARE / 16,677 cartons | Class III | Ongoing |
| D-0200-2025 | 12-18-2024 | Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134 | Non-Sterility | Alcon Research LLC / 55,960 25-count boxes | Class I | Ongoing |
| D-0202-2025 | 12-17-2024 | glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11 | Failed Dissolution Specifications: | Amerisource Health Services LLC / 2,028 units (cartons of 30 individual unit doses) | Class II | Ongoing |
| D-0207-2025 | 12-16-2024 | FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7 | Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide | SHOPPERS- PLAZA / 172 180-count bottles | Class I | Ongoing |
| D-0169-2025 | 12-16-2024 | Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01 Package NDCs: 70069-716-01 | Failed Impurities/Degradation Specifications | SOMERSET THERAPEUTICS LLC / 5,870 bottles | Class III | Terminated |
| D-0182-2025 | 12-16-2024 | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, 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 / 136,181 bottles | Class II | Ongoing |
| D-0184-2025 | 12-13-2024 | Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21 Package NDCs: 60687-423-11; 60687-423-21 | Presence of Foreign Tablets/Capsules | Amerisource Health Services LLC / 5,178 cartons | Class II | Ongoing |
| D-0197-2025 | 12-12-2024 | Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1. | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. / 7198 bottles | Class III | Ongoing |
| D-0193-2025 | 12-12-2024 | Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01. | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. / 768 bottles | Class III | Ongoing |
| D-0170-2025 | 12-12-2024 | FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles | Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone. | GNMart LLC / 374 bottles | Class I | Ongoing |
| D-0177-2025 | 12-12-2024 | Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang, Malasia. | Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine | Buy-Herbal / 26 bottles | Class I | Ongoing |
| D-0194-2025 | 12-12-2024 | Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 . | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. / 6429 bottles | Class III | Ongoing |
| D-0196-2025 | 12-12-2024 | Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02 | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. / 1232 bottles | Class III | Ongoing |
| D-0199-2025 | 12-12-2024 | Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02. | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. / 324 bottles | Class III | Ongoing |
| D-0195-2025 | 12-12-2024 | Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01. | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. / 14825 bottles | Class III | Ongoing |
| D-0198-2025 | 12-12-2024 | Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2. | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. / 456 bottles | Class III | Ongoing |
| D-0129-2025 | 12-12-2024 | Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60 Package NDCs: 67877-475-60; 67877-474-60 | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit | Ascend Laboratories, LLC / 1971 bottles | Class II | Ongoing |
| D-0130-2025 | 12-12-2024 | Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60 Package NDCs: 67877-475-60; 67877-474-60 | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit | Ascend Laboratories, LLC / 10,444 bottles | Class II | Ongoing |
| D-0160-2025 | 12-11-2024 | chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01 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: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / | Class II | Ongoing |
| D-0159-2025 | 12-11-2024 | chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01 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: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 3,888 | Class II | Ongoing |
| D-0171-2025 | 12-10-2024 | Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack Package NDCs: 72578-094-01; 72578-094-02; 72578-094-03 | Crystallization | VIONA PHARMACEUTICALS INC / 23304 packs | Class II | Ongoing |
| D-0172-2025 | 12-10-2024 | Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack Package NDCs: 72578-094-01; 72578-094-02; 72578-094-03 | Crystallization | VIONA PHARMACEUTICALS INC / 2760 packs | Class II | Ongoing |
| D-0153-2025 | 12-10-2024 | PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-003-01 Package NDCs: 82305-003-01; 82305-003-02 | Lack of Sterility Assurance | Regenerative Processing Plant, LLC / 59275 | Class II | Terminated |
| D-0152-2025 | 12-10-2024 | LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-006-01 Package NDCs: 82305-006-01; 82305-006-02 | Lack of Sterility Assurance | Regenerative Processing Plant, LLC / 170812 bottles | Class II | Terminated |
| D-0161-2025 | 12-06-2024 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, 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 N-nitroso-duloxetine impurity above FDA recommended interim limit. | Breckenridge Pharmaceutical, Inc / 163,883 bottles | Class II | Ongoing |
| D-0155-2025 | 12-06-2024 | Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04 Package NDCs: 68001-413-06; 68001-414-04; 68001-414-05; 68001-414-08; 68001-415-04; 68001-415-05; 68001-415-08 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Amerisource Health Services LLC / 21,262 bottles | Class II | Ongoing |
| D-0158-2025 | 12-06-2024 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08 Package NDCs: 68001-413-06; 68001-414-04; 68001-414-05; 68001-414-08; 68001-415-04; 68001-415-05; 68001-415-08 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Amerisource Health Services LLC / 1,815 bottles | Class II | Ongoing |
| D-0149-2025 | 12-06-2024 | Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30 Package NDCs: 59651-137-30; 59651-137-90; 59651-138-30; 59651-138-90; 59651-139-30; 59651-139-90; 59651-140-30; 59651-140-90 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit. | Aurobindo Pharma USA Inc / | Class II | Ongoing |
| D-0162-2025 | 12-06-2024 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, 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 N-nitroso-duloxetine impurity above FDA recommended interim limit. | Breckenridge Pharmaceutical, Inc / 76,968 bottles | Class II | Ongoing |
| D-0157-2025 | 12-06-2024 | Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04 Package NDCs: 68001-413-06; 68001-414-04; 68001-414-05; 68001-414-08; 68001-415-04; 68001-415-05; 68001-415-08 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Amerisource Health Services LLC / 20,734 30-count bottles | Class II | Ongoing |
| D-0156-2025 | 12-06-2024 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05 Package NDCs: 68001-413-06; 68001-414-04; 68001-414-05; 68001-414-08; 68001-415-04; 68001-415-05; 68001-415-08 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Amerisource Health Services LLC / 13,678 bottles | Class II | Ongoing |
| D-0114-2025 | 12-05-2024 | Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15. Package NDCs: 64980-513-05; 64980-513-01; 64980-513-15; 64980-514-05; 64980-514-01; 64980-514-15 | 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 / 5184 bottles | Class II | Ongoing |
| D-0163-2025 | 12-04-2024 | DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90 Package NDCs: 43063-877-90 | CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit | PD-Rx Pharmaceuticals, Inc. / 70, 90-count bottles | Class II | Terminated |
| D-0168-2025 | 12-04-2024 | Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15. Package NDCs: 50268-625-11; 50268-625-15 | Failed Dissolution Specifications | AvKARE / 1016 50-count cartons | Class II | Ongoing |
| D-0165-2025 | 12-02-2024 | Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA | CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit. | RemedyRepack Inc. / a) 1,564 cards, b) 799 bottles | Class II | Ongoing |
| D-0109-2025 | 11-27-2024 | Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30 | CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. | AvKARE / 2,396 bottles | Class II | Ongoing |
| D-0110-2025 | 11-27-2024 | Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30 | CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. | AvKARE / 2,796 bottles | Class II | Ongoing |
| D-0108-2025 | 11-27-2024 | Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30 | CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. | AvKARE / 50,304 bottles | Class II | Ongoing |
| D-0164-2025 | 11-26-2024 | Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 mg; Stannous Chloride Dihydrate - 0.D75 mg; L-Cysteine Hydrochloride Monohydrate - 1 mg; Sodium Citrate Dihydrate - 2.6 mg; Mannitol - 20 mg. The pH is adjusted to 5.6 to 5.7 with HCI or NaOH prior to lyophilization. Sealed under nitrogen. 30 Radioassay Information Labels with radiation warning symbol. 1 package insert, Rx only, Manufacture by: Curium US LLC, Maryland Heights, MO 63043, 69945-092-40 Package NDCs: 69945-092-20; 69945-092-40 | Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product | Curium US, LLC / 5,160 vials (172 kits 30 vials/kit) | Class II | Ongoing |
| D-0154-2025 | 11-25-2024 | Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07. Package NDCs: 33342-067-07; 33342-067-44; 33342-067-12; 33342-067-11; 33342-068-07; 33342-068-44; 33342-068-12; 33342-068-11; 33342-069-07; 33342-069-44; 33342-069-12; 33342-069-11; 33342-070-07; 33342-070-15; 33342-070-12; 33342-070-44; 33342-070-11; 33342-071-07; 33342-071-15; 33342-071-12; 33342-071-44; 33342-071-11; 33342-072-07; 33342-072-15; 33342-072-12; 33342-072-44; 33342-072-11 | Failed Impurities/Degradation Specifications | Macleods Pharmaceuticals Ltd / 15,744 30-count bottles | Class II | Ongoing |
| D-0111-2025 | 11-22-2024 | 10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottle, For Professional Use Only, Only YourRx Inc., Chatsworth, CA 91311, Made in USA, Onlyyourrx.com. | CGMP Deviations: Inconsistency in the water systems. | Generitech Corporation / 77.5lbs | Class II | Ongoing |
| D-0191-2025 | 11-22-2024 | Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05. | Failed Stability Specifications | Jubilant Draximage Inc., dba Jubilant Radiopharma / 5209 kits | Class II | Ongoing |
| D-0117-2025 | 11-22-2024 | Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04. Package NDCs: 43598-096-30; 43598-096-04; 43598-096-05 | Failed Impurities/Degradation Specifications | Dr. Reddy's Laboratories, Inc. / 7,233 bottles | Class III | Ongoing |
| D-0150-2025 | 11-22-2024 | Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05 Package NDCs: 81284-411-00; 81284-411-05; 81284-411-10 | Discoloration | Provepharm Inc. / 2160 packs/5 ampules per pack = 10,800 ampules | Class II | Ongoing |
| D-0151-2025 | 11-22-2024 | VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmaceutical Corp., Ronkonkoma, NY 11779, NDC 52925-512-10 | CGMP deviations: out of specifications for assay | Apothecus Pharmaceutical Corp. / 33,659 retail boxes in US | Class II | Ongoing |
| D-0133-2025 | 11-19-2024 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. 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 | Subpotent and Superpotent Drug | Mylan Institutional, Inc. / 1,664 cartons | Class II | Ongoing |
| D-0135-2025 | 11-19-2024 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. 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 | Subpotent and Superpotent Drug | Mylan Institutional, Inc. / 690 cartons | Class II | Ongoing |
