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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

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

Teva Pharmaceuticals USA

Class I - Dangerous

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 specified lots.

Oct 7, 2025 Prescription Drugs Nationwide View Details →

Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06

ProRx

Class I - Dangerous

Lack of Assurance of Sterility

Oct 15, 2025 Prescription Drugs View Details →

Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-051-88.

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

Oct 28, 2025 Prescription Drugs Nationwide View Details →

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

Teva Pharmaceuticals USA

Class I - Dangerous

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 specified lots.

Oct 7, 2025 Prescription Drugs Nationwide View Details →

Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01

FARMAKEIO OUTSOURCING

Class I - Dangerous

CGMP Deviations: Potential presence of metal particulate matter

Oct 14, 2025 Prescription Drugs Nationwide View Details →

Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

Heritage Pharmaceuticals

Class I - Dangerous

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Oct 6, 2025 Prescription Drugs Nationwide View Details →

Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01

FARMAKEIO OUTSOURCING

Class I - Dangerous

CGMP Deviations: Potential presence of metal particulate matter

Oct 14, 2025 Prescription Drugs Nationwide View Details →

Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604

Letco Medical

Class I - Dangerous

Labeling: Not Elsewhere Classified

Sep 12, 2025 Other Drugs View Details →

Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91

Endo USA

Class I - Dangerous

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

Oct 10, 2025 Prescription Drugs Nationwide View Details →

Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09

ProRx

Class I - Dangerous

Lack of Assurance of Sterility

Oct 15, 2025 Prescription Drugs View Details →

HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01.

Samsung Bioepis Co.

Class I - Dangerous

Lack of Assurance of Sterility.

Oct 10, 2025 Prescription Drugs View Details →

Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03

ProRx

Class I - Dangerous

Lack of Assurance of Sterility

Oct 15, 2025 Prescription Drugs View Details →

Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01

FARMAKEIO OUTSOURCING

Class I - Dangerous

CGMP Deviations: Potential presence of metal particulate matter

Oct 14, 2025 Prescription Drugs Nationwide View Details →

Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

Heritage Pharmaceuticals

Class I - Dangerous

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Oct 6, 2025 Prescription Drugs Nationwide View Details →

TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04.

Kenvue Brands

Class I - Dangerous

Defective Container

Oct 21, 2025 Other Drugs Nationwide View Details →

Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-050-88.

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

Oct 28, 2025 Prescription Drugs Nationwide View Details →

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 60687-572-33

Amerisource Health Services

Class I - Dangerous

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

Oct 16, 2025 Prescription Drugs Nationwide View Details →

Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09

ProRx

Class I - Dangerous

Lack of Assurance of Sterility

Oct 15, 2025 Prescription Drugs View Details →

Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01

FARMAKEIO OUTSOURCING

Class I - Dangerous

CGMP Deviations: Potential presence of metal particulate matter

Oct 14, 2025 Prescription Drugs Nationwide View Details →

Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91

Endo USA

Class I - Dangerous

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

Oct 10, 2025 Prescription Drugs Nationwide View Details →