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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1

Zydus Pharmaceuticals (USA)

Class I - Dangerous

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Apr 3, 2025 Prescription Drugs Nationwide View Details →

Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05.

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

Cross Contamination

Mar 4, 2025 Prescription Drugs Nationwide View Details →

Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01.

Zydus Pharmaceuticals (USA)

Class I - Dangerous

Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.

Mar 21, 2025 Prescription Drugs Nationwide View Details →

Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-890-01

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-680-60.

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-409-60

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-572-30.

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-433-18

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-639-45.

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-679-60

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton)

Somerset Therapeutics Private Limited

Class I - Dangerous

Lack of Assurance of Sterility: Media fill with bacterial contamination

Mar 21, 2025 Prescription Drugs Nationwide View Details →

Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-559-01

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 NDC# 68462-164-05.

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 fl. oz. (177.4 mL), UPC 7 35786 01528 2; b) 0.33 OZ (9.45g), UPC 8 42944 10223 1; Distributed by Alchemee, LLC, Santa Monica, CA 90401,

Alchemee

Class I - Dangerous

Chemical contamination: Presence of benzene

Mar 12, 2025 Other Drugs Nationwide View Details →

Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-825-01.

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →