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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-562-01

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10

B. Braun Medical

Class I - Dangerous

Presence of Particulate Matter

Mar 31, 2025 Other Drugs Nationwide View Details →

Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 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 →

Lacosamide Tablets 200mg, 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# 68462-681-60.

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-338-01

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-826-01

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Rosuvastatin Tablets 40mg, 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# 68462-264-30

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-325-60

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-144-01

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, 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 →

Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-638-01

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)

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 →

Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-678-60

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), Distributed by Alchemee LLC, Santa Monica, CA 90401, Made in the USA, UPC 7 35786 01921 1, UPC 8 42944 10223 1, and also packaged as a twin pack UPC 8 42944 10241 5,

Alchemee

Class I - Dangerous

Chemical contamination: Presence of benzene

Mar 12, 2025 Other Drugs Nationwide View Details →

Propafenone Hydrochloride Extended-Release Capsules 225mg, 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# 68462-408-60

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Voriconazole Tablets 200 mg, 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# 68462-573-30

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),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 →

Teriflunomide Tablets, 14mg, 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# 68462-424-30

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-336-01

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations

Mar 13, 2025 Prescription Drugs Nationwide View Details →

Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13

BIOCON PHARMA

Class I - Dangerous

Failed dissolution specifications: lower than specifications

Mar 17, 2025 Prescription Drugs Nationwide View Details →