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-0134-2025 | 11-19-2024 | Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 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: 42292-041-20 Package NDCs: 42292-038-01; 42292-038-20; 42292-039-01; 42292-039-20; 42292-041-01; 42292-041-20; 42292-040-01; 42292-040-20 | Subpotent and Superpotent Drug | Mylan Institutional, Inc. / 1,133 cartons | Class II | Ongoing |
| D-0132-2025 | 11-19-2024 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 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: 42292-039-20 Package NDCs: 42292-038-01; 42292-038-20; 42292-039-01; 42292-039-20; 42292-041-01; 42292-041-20; 42292-040-01; 42292-040-20 | Subpotent and Superpotent Drug | Mylan Institutional, Inc. / 988 cartons | Class II | Ongoing |
| D-0136-2025 | 11-19-2024 | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 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: 42292-040-20 Package NDCs: 42292-038-01; 42292-038-20; 42292-039-01; 42292-039-20; 42292-041-01; 42292-041-20; 42292-040-01; 42292-040-20 | Subpotent and Superpotent Drug | Mylan Institutional, Inc. / 205 cartons | Class II | Ongoing |
| D-0131-2025 | 11-19-2024 | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 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: 51079-442-20 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. / 2,835 cartons | Class II | Ongoing |
| D-0105-2025 | 11-19-2024 | Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma 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. / 209,376 bottles | Class II | Ongoing |
| D-0106-2025 | 11-19-2024 | Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma 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. / 122,925 bottles | Class II | Ongoing |
| D-0107-2025 | 11-19-2024 | Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, 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. / 233,003 bottles | Class II | Ongoing |
| D-0121-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 19, 549 bottles | Class II | Ongoing |
| D-0124-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 42,331 bottles | Class II | Ongoing |
| D-0180-2025 | 11-18-2024 | Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-307-02 (carton), NDC #: 49884-307-52 (blisters). Package NDCs: 49884-306-02; 49884-307-02; 49884-308-02; 49884-309-02; 49884-310-02; 49884-307-52 | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. | Endo USA, Inc. / 72,973 cartons | Class I | Ongoing |
| D-0127-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 65,169 | Class II | Ongoing |
| D-0118-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 92,512 bottles | Class II | Ongoing |
| D-0128-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 35,883 bottles | Class II | Ongoing |
| D-0178-2025 | 11-18-2024 | Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters). Package NDCs: 49884-306-02; 49884-307-02; 49884-308-02; 49884-309-02; 49884-310-02; 49884-310-52 | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. | Endo USA, Inc. / 9,816 cartons | Class I | Ongoing |
| D-0125-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 63,077 bottles | Class II | Ongoing |
| D-0122-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 55,032 bottles | Class II | Ongoing |
| D-0181-2025 | 11-18-2024 | Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (carton), NDC #: 49884-309-52 (blisters). Package NDCs: 49884-306-02; 49884-307-02; 49884-308-02; 49884-309-02; 49884-310-02; 49884-309-52 | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. | Endo USA, Inc. / 22,513 cartons | Class I | Ongoing |
| D-0126-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 43,765 bottles | Class II | Ongoing |
| D-0119-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 118,324 bottles | Class II | Ongoing |
| D-0123-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC 0378-1800-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 34,845 bottes | Class II | Ongoing |
| D-0120-2025 | 11-18-2024 | Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc / 9,828 bottles | Class II | Ongoing |
| D-0179-2025 | 11-18-2024 | Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-306-02 (carton), NDC #: 49884-306-52 (blisters). Package NDCs: 49884-306-02; 49884-307-02; 49884-308-02; 49884-309-02; 49884-310-02; 49884-306-52 | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. | Endo USA, Inc. / 8,029 cartons | Class I | Ongoing |
| D-0061-2025 | 11-15-2024 | Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC# 68645-610-90. Package NDCs: 68645-609-90; 68645-610-90; 68645-611-90; 68645-608-90; 68645-612-90; 68645-613-90 | Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet. | Evaric Pharmaceuticals Inc. / 222, 600 bottles | Class II | Ongoing |
| D-0099-2025 | 11-14-2024 | Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06 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 / 37,916 bottles | Class II | Ongoing |
| D-0115-2025 | 11-14-2024 | Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night - 56 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg); Manufactured BY: LNK International, Inc. FOR: Costco Wholesale Corporation. NDC# 63981-795-81 Package NDCs: 63981-795-81 | CGMP Deviations: Released product should have been rejected. | LNK International, Inc. / 288 cases x 30 8,640 boxes | Class II | Completed |
| D-0145-2025 | 11-14-2024 | safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, Made in USA, For Professional Use Only. Package NDCs: 67239-0219-1 | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Ongoing |
| D-0141-2025 | 11-14-2024 | Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson Dental Supply, Inc. 1031 Mendota Heights Road, Saint Paul, MN 55120, NDC 50227-1002-3. Package NDCs: 50227-1002-3 | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Ongoing |
| D-0142-2025 | 11-14-2024 | Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30. Package NDCs: 69634-021-30 | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Ongoing |
| D-0101-2025 | 11-14-2024 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, 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 / 8,561 bottles | Class II | Ongoing |
| D-0100-2025 | 11-14-2024 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories 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 / 23,490 bottles | Class II | Ongoing |
| D-0148-2025 | 11-14-2024 | Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only, | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Ongoing |
| D-0147-2025 | 11-14-2024 | Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada. | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Ongoing |
| D-0140-2025 | 11-14-2024 | Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental City, Green Bay, WI 54311, dentalcity.com. | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Ongoing |
| D-0137-2025 | 11-14-2024 | Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC# 68400-352-30. Package NDCs: 68400-352-30 | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Ongoing |
| D-0139-2025 | 11-14-2024 | Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022. | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Ongoing |
| D-0138-2025 | 11-14-2024 | M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416. | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Ongoing |
| D-0146-2025 | 11-14-2024 | Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 37086, www.quala.com | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Ongoing |
| D-0144-2025 | 11-14-2024 | Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA. | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Ongoing |
| D-0102-2025 | 11-14-2024 | Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets Package NDCs: 68382-848-94; 68382-849-94 | Labeling: Not Elsewhere Classified - Wrong NDC number | Zydus Pharmaceuticals (USA) Inc / 4404 packs | Class III | Ongoing |
| D-0166-2025 | 11-14-2024 | UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323 | cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted. | MXBBB / 321 bottles | Class II | Ongoing |
| D-0143-2025 | 11-14-2024 | Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409. | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. | Keystone Industries / | Class II | Ongoing |
| D-0205-2025 | 11-13-2024 | Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3 | CGMP Deviations: lack of adequate release testing. | Brands International Corporation / unknown | Class II | Ongoing |
| D-0059-2025 | 11-11-2024 | Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01 Package NDCs: 48433-106-01 | cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. | Safecor Health, LLC / 791 boxes | Class II | Ongoing |
| D-0082-2025 | 11-11-2024 | Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (25 x 5 mL/vial cartons). Package NDCs: 0517-2325-01; 0517-2325-10; 0517-2340-01; 0517-2340-10; 0517-2340-25; 0517-2310-01; 0517-2310-05 | Presence of Particulate Matter: Potential for glass delamination from the vials. | American Regent, Inc. / | Class II | Ongoing |
| D-0058-2025 | 11-11-2024 | Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01 Package NDCs: 48433-129-01 | cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. | Safecor Health, LLC / 1470 boxes | Class II | Ongoing |
| D-0057-2025 | 11-11-2024 | Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01 | cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. | Safecor Health, LLC / 3139 boxes | Class II | Ongoing |
| D-0056-2025 | 11-11-2024 | Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01 | cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. | Safecor Health, LLC / 7488 boxes | Class II | Ongoing |
| D-0060-2025 | 11-11-2024 | Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01 | cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. | Safecor Health, LLC / 587 boxes | Class II | Ongoing |
| D-0080-2025 | 11-11-2024 | Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons). Package NDCs: 49230-530-01; 49230-530-10; 49230-530-25; 49230-534-01; 49230-534-10; 49230-534-25 | Presence of Particulate Matter: Potential for glass delamination from the vials. | American Regent, Inc. / | Class II | Ongoing |
| D-0081-2025 | 11-11-2024 | Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons). Package NDCs: 49230-530-01; 49230-530-10; 49230-530-25; 49230-534-01; 49230-534-10; 49230-534-25 | Presence of Particulate Matter: Potential for glass delamination from the vials. | American Regent, Inc. / | Class II | Ongoing |
| D-0076-2025 | 11-08-2024 | Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17 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 drug | ACCORD HEALTHCARE, INC. / | Class II | Ongoing |
| D-0079-2025 | 11-07-2024 | Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05 Package NDCs: 65862-831-30; 65862-831-90; 65862-831-01; 65862-831-05; 65862-832-30; 65862-832-90; 65862-832-01; 65862-832-05; 65862-833-30; 65862-833-90; 65862-833-01; 65862-833-05 | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Aurobindo Pharma USA Inc / | Class II | Ongoing |
| D-0078-2025 | 11-07-2024 | Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. Package NDCs: 65862-831-30; 65862-831-90; 65862-831-01; 65862-831-05; 65862-832-30; 65862-832-90; 65862-832-01; 65862-832-05; 65862-833-30; 65862-833-90; 65862-833-01; 65862-833-05 | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Aurobindo Pharma USA Inc / 3336 bottles | Class II | Ongoing |
| D-0077-2025 | 11-07-2024 | Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. Package NDCs: 65862-831-30; 65862-831-90; 65862-831-01; 65862-831-05; 65862-832-30; 65862-832-90; 65862-832-01; 65862-832-05; 65862-833-30; 65862-833-90; 65862-833-01; 65862-833-05 | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Aurobindo Pharma USA Inc / 102576 bottles | Class II | Ongoing |
| D-0050-2025 | 11-07-2024 | Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70 | Failed Impurity/Degradation Specifications | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / N/A | Class II | Ongoing |
| D-0049-2025 | 11-07-2024 | Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72 | Failed Impurity/Degradation Specifications | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / N/A | Class II | Ongoing |
| D-0051-2025 | 11-06-2024 | BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Healthcare: 24416 N 19th Ave, Phoenix, AZ, NDC 81483-0041-1 | Lack of Sterility Assurance | Tailstorm Health INC / 27,560 Syringes | Class II | Terminated |
| D-0087-2025 | 11-06-2024 | MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303 | cGMP Deviations: Out of specification results for micro in hand soap products. | Midlab Incorporated / | Class II | Ongoing |
| D-0089-2025 | 11-06-2024 | Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509 | cGMP Deviations: Out of specification results for micro in hand soap products. | Midlab Incorporated / | Class II | Ongoing |
| D-0091-2025 | 11-06-2024 | Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339 | cGMP Deviations: Out of specification results for micro in hand soap products. | Midlab Incorporated / | Class II | Ongoing |
| D-0090-2025 | 11-06-2024 | ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139 | cGMP Deviations: Out of specification results for micro in hand soap products. | Midlab Incorporated / | Class II | Ongoing |
| D-0088-2025 | 11-06-2024 | boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015 | cGMP Deviations: Out of specification results for micro in hand soap products. | Midlab Incorporated / | Class II | Ongoing |
| D-0092-2025 | 11-06-2024 | Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal Corporation, 10232 Palm Drive, Santa Fe Springs, CA 90670 | cGMP Deviations: Out of specification results for micro in hand soap products. | Midlab Incorporated / | Class II | Ongoing |
| D-0042-2025 | 11-06-2024 | Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC 29716, USA, Ph: 704-629-8203, www.trinitygold.com, Made in India, UPC 802992001009 | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone. | Trinity Gold Nutrition / 150 | Class II | Ongoing |
| D-0045-2025 | 11-05-2024 | Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61. | Failed Impurities/Degradation Specifications; during routine stability testing for impurities. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 25814 tablets | Class III | Ongoing |
| D-0086-2025 | 11-04-2024 | ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. | Boulla LLC / Unknown | Class I | Ongoing |
| D-0084-2025 | 11-04-2024 | PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. | Boulla LLC / Unknown | Class I | Ongoing |
| D-0085-2025 | 11-04-2024 | ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. | Boulla LLC / Unknown | Class I | Ongoing |
| D-0083-2025 | 11-04-2024 | VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. | Boulla LLC / Unknown | Class I | Ongoing |
| D-0098-2025 | 11-01-2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-555-01. Package NDCs: 16714-553-01; 16714-554-01; 16714-555-01 | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. | Glenmark Pharmaceuticals Inc., USA / 7296 bottles | Class II | Ongoing |
| D-0094-2025 | 11-01-2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01. Package NDCs: 68462-850-01; 68462-851-01; 68462-562-01 | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. | Glenmark Pharmaceuticals Inc., USA / 12,864 bottles | Class II | Ongoing |
| D-0093-2025 | 11-01-2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-850-01. Package NDCs: 68462-850-01; 68462-851-01; 68462-562-01 | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. | Glenmark Pharmaceuticals Inc., USA / 34848 bottles | Class II | Ongoing |
| D-0097-2025 | 11-01-2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-554-01. Package NDCs: 16714-553-01; 16714-554-01; 16714-555-01 | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. | Glenmark Pharmaceuticals Inc., USA / 4704 bottles | Class II | Ongoing |
| D-0095-2025 | 11-01-2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01. Package NDCs: 68462-850-01; 68462-851-01; 68462-562-01 | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. | Glenmark Pharmaceuticals Inc., USA / 25584 bottles | Class II | Ongoing |
| D-0096-2025 | 11-01-2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-553-01. Package NDCs: 16714-553-01; 16714-554-01; 16714-555-01 | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. | Glenmark Pharmaceuticals Inc., USA / 5232 bottles | Class II | Ongoing |
| D-0075-2025 | 11-01-2024 | Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05 Package NDCs: 72342-100-05 | cGMP Deviations | JR Watkins / 7,138 patches | Class II | Completed |
| D-0055-2025 | 10-31-2024 | Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN PHARMACEUTICALS, INC., Miami, FL 33186 United Sates, NDC 68968-0215-3 Package NDCs: 68968-0205-1; 68968-0205-3; 68968-0210-1; 68968-0210-3; 68968-0215-1; 68968-0215-3; 68968-0220-1; 68968-0220-3 | Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive). | Noven Pharmaceuticals Inc / 685 boxes | Class II | Ongoing |
| D-0039-2025 | 10-30-2024 | Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC: 36000-364-01 Package NDCs: 36000-364-01 | Labeling: Missing Label | Baxter Healthcare Corporation / 60,594 units | Class II | Ongoing |
| D-0035-2025 | 10-29-2024 | 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 / 155,232 bottles | Class II | Ongoing |
| D-0047-2025 | 10-29-2024 | IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05 Package NDCs: 55111-682-09; 55111-682-01; 55111-682-05; 55111-683-30; 55111-683-50; 55111-683-09; 55111-683-01; 55111-683-05; 55111-684-30; 55111-684-50; 55111-684-60; 55111-684-09; 55111-684-01; 55111-684-05 | Failed Tablet/Capsule Specifications | Dr. Reddy's Laboratories, Inc. / 3416 botttles | Class III | Ongoing |
| D-0038-2025 | 10-29-2024 | Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. Package NDCs: 72578-094-01; 72578-094-02; 72578-094-03 | Crystallization | VIONA PHARMACEUTICALS INC / 6048 pumps | Class II | Ongoing |
| D-0112-2025 | 10-25-2024 | Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37 Package NDCs: 0527-4661-37; 0527-4662-37; 0527-4663-37; 0527-4664-37; 0527-4665-37; 0527-4666-37; 0527-4667-37 | Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity. | Lannett Company Inc. / 1608 bottles | Class II | Terminated |
| D-0072-2025 | 10-24-2024 | PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Pharmadel LLC, Georgetown, DE 19947 NDC 55758-039-01, UPC 8 59424 00433 6 Package NDCs: 55758-039-01; 55758-039-06 | cGMP Deviations | Unexo Life Sciences Private Limited / 28,864 patches | Class II | Ongoing |
| D-0064-2025 | 10-24-2024 | ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches (UPC 8 89476 41306 0), Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 | cGMP Deviations | Unexo Life Sciences Private Limited / 946,080 patches | Class II | Ongoing |
| D-0071-2025 | 10-24-2024 | CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9 | cGMP Deviations | Unexo Life Sciences Private Limited / 17,928 patches | Class II | Ongoing |
| D-0067-2025 | 10-24-2024 | HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-947-10, UPC 8 45717 01072 6 Package NDCs: 71101-947-10 | cGMP Deviations | Unexo Life Sciences Private Limited / 10,368 patches | Class II | Ongoing |
| D-0062-2025 | 10-24-2024 | ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 UPC 8 89476 41218 6, UPC 8 89476 41236 0 | cGMP Deviations | Unexo Life Sciences Private Limited / 6,848,820 patches | Class II | Ongoing |
| D-0066-2025 | 10-24-2024 | THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-954-05, UPC 8 45717 00818 1 Package NDCs: 71101-954-05 | cGMP Deviations | Unexo Life Sciences Private Limited / 279,936 patches | Class II | Ongoing |
| D-0063-2025 | 10-24-2024 | ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 41336 7 | cGMP Deviations | Unexo Life Sciences Private Limited / 4,968,000 patches | Class II | Ongoing |
| D-0070-2025 | 10-24-2024 | JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294 00878 5 | cGMP Deviations | Unexo Life Sciences Private Limited / 10,368 patches | Class II | Ongoing |
| D-0065-2025 | 10-24-2024 | THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches (NDC 71101-001-06, UPC 8 45717 01056 6), Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 Package NDCs: 71101-001-06; 71101-001-24 | cGMP Deviations | Unexo Life Sciences Private Limited / 455,536 patches | Class II | Ongoing |
| D-0069-2025 | 10-24-2024 | LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099 48211 4), Distributed by: Lilas Wellness, Inc., Beaverton, Oregon 97008-7105 | cGMP Deviations | Unexo Life Sciences Private Limited / 363,300 patches | Class II | Ongoing |
| D-0068-2025 | 10-24-2024 | EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical Anesthetic, 6 patches per box PATCHES, LIDOCAINE 4%, Distributed by: Walmart Inc., Bentonville, AR 72716 NDC 79903-106-06 Package NDCs: 79903-106-06 | cGMP Deviations | Unexo Life Sciences Private Limited / 1,101,600 patches | Class II | Ongoing |
| D-0052-2025 | 10-23-2024 | Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India Package NDCs: 68180-589-09; 68180-589-10; 68180-589-01; 68180-589-02; 68180-590-09; 68180-590-10; 68180-590-01; 68180-590-02; 68180-591-09; 68180-591-10; 68180-591-02; 68180-591-01; 68180-588-01; 68180-588-02; 68180-588-09 | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor | Lupin Pharmaceuticals Inc. / 112,770 bottles | Class II | Ongoing |
| D-0054-2025 | 10-23-2024 | Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India Package NDCs: 68180-589-09; 68180-589-10; 68180-589-01; 68180-589-02; 68180-590-09; 68180-590-10; 68180-590-01; 68180-590-02; 68180-591-09; 68180-591-10; 68180-591-02; 68180-591-01; 68180-588-01; 68180-588-02; 68180-588-09 | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor | Lupin Pharmaceuticals Inc. / 357,414 bottles | Class II | Ongoing |
| D-0053-2025 | 10-23-2024 | Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India Package NDCs: 68180-589-09; 68180-589-10; 68180-589-01; 68180-589-02; 68180-590-09; 68180-590-10; 68180-590-01; 68180-590-02; 68180-591-09; 68180-591-10; 68180-591-02; 68180-591-01; 68180-588-01; 68180-588-02; 68180-588-09 | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor | Lupin Pharmaceuticals Inc. / 146,322 bottles | Class II | Ongoing |
| D-0043-2025 | 10-23-2024 | Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98 | Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. | Cipla USA, Inc. / 1,875 boxes (cipla and exlan) | Class II | Ongoing |
| D-0044-2025 | 10-23-2024 | Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90 | Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. | Cipla USA, Inc. / N/A | Class II | Ongoing |
| D-0036-2025 | 10-22-2024 | Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01. | Failed Impurities/Degradation Specification | Dr. Reddy's Laboratories, Inc. / 2,040 100-count bottles | Class II | Ongoing |
| D-0037-2025 | 10-22-2024 | Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01. | Failed Impurities/Degradation Specification | Dr. Reddy's Laboratories, Inc. / 532 100-count bottles | Class II | Ongoing |
