AvKARE
9 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for AvKARE and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-03-04FDA-DrugClass IIAmantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
- 2026-01-14FDA-DrugClass IIRosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15
Out of specification for dissolution.
- 2025-10-15FDA-DrugClass IINorgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84; Blister NDC: 42291-565-28
Failed Content Uniformity Specifications
- 2025-09-17FDA-DrugClass IIchloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15
Presence of a foreign substance.
- 2025-09-17FDA-DrugClass IIchloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15
Presence of a foreign substance.
- 2025-07-09FDA-DrugClass IIIPitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
Failed Impurity/Degradation Specifications
- 2025-07-09FDA-DrugClass IIIPitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
Failed Impurity/Degradation Specifications
- 2025-06-18FDA-DrugClass IIChlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15
Failed Dissolution Specifications
- 2025-06-18FDA-DrugClass IICelecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
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