Drug Recalls

Teva Pharmaceuticals USA, Inc

Class II Ongoing

Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10

Reason: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specifie...

D-0105-2026 November 5, 2025 Parsippany, NJ

Amerisource Health Services LLC

Class II Ongoing

Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC ...

Reason: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

D-0101-2026 November 5, 2025 Columbus, OH

Teva Pharmaceuticals USA, Inc

Class II Ongoing

Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10

Reason: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specifie...

D-0104-2026 November 5, 2025 Parsippany, NJ

Amerisource Health Services LLC

Class II Ongoing

Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 606...

Reason: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

D-0103-2026 November 5, 2025 Columbus, OH

Teva Pharmaceuticals USA, Inc

Class II Ongoing

Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500...

Reason: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specifie...

D-0106-2026 November 5, 2025 Parsippany, NJ

Amerisource Health Services LLC

Class II Ongoing

Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-997-01, Individual unit dose: NDC 6...

Reason: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

D-0102-2026 November 5, 2025 Columbus, OH

Mckesson Medical-Surgical Inc. Corporate Office

Class II Ongoing

Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, Manufactured for: Sandoz Inc., Princeton, NJ 08540, Distributed by Baxter Healthc...

Reason: Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 ...

D-0401-2025 May 7, 2025 Richmond, VA

Mckesson Medical-Surgical Inc. Corporate Office

Class II Ongoing

Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01

Reason: Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 ...

D-0400-2025 May 7, 2025 Richmond, VA

OurPharma LLC

Class III Terminated

HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01.

Reason: Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..

D-0385-2025 April 30, 2025 Fayetteville, AR

One Source Nutrition, Inc,

Class I Ongoing

Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.

Reason: Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.

D-0281-2025 March 26, 2025 Benton, AR

Mylan Institutional, Inc.

Class II Ongoing

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in Ind...

Reason: Super-Potent Drug: Out of specification potency results were obtained.

D-0290-2025 March 26, 2025 Rockford, IL

Mylan Institutional, Inc.

Class II Ongoing

Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in In...

Reason: Super-Potent Drug: Out of specification potency results were obtained.

D-0291-2025 March 26, 2025 Rockford, IL

Viatris Inc

Class II Ongoing

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. Morgant...