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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 41–60 of 436 recalls

Class IICompleted

Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-308-88.

SUN PHARMACEUTICAL INDUSTRIES INC

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

January 18, 2024 · DrugView details →

Class IICompleted

Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 63304-175-13.

SUN PHARMACEUTICAL INDUSTRIES INC

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

January 18, 2024 · Drug

View details →

Class IICompleted

Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), India, NDC 47335-380-83.

SUN PHARMACEUTICAL INDUSTRIES INC

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

January 18, 2024 · DrugView details →

Class IICompleted

Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-579-83.

SUN PHARMACEUTICAL INDUSTRIES INC

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

January 18, 2024 · DrugView details →

Class IICompleted

Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-539-81.

SUN PHARMACEUTICAL INDUSTRIES INC

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

January 18, 2024 · DrugView details →

Class IICompleted

Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-613-81.

SUN PHARMACEUTICAL INDUSTRIES INC

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

January 18, 2024 · DrugView details →

Class IICompleted

Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-722-83.

SUN PHARMACEUTICAL INDUSTRIES INC

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

January 18, 2024 · DrugView details →

Class IICompleted

Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 47335-721-83.

SUN PHARMACEUTICAL INDUSTRIES INC

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

January 18, 2024 · DrugView details →

Class IICompleted

Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-307-88.

SUN PHARMACEUTICAL INDUSTRIES INC

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

January 18, 2024 · DrugView details →

Class IICompleted

Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India.

SUN PHARMACEUTICAL INDUSTRIES INC

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

January 18, 2024 · DrugView details →

Class IICompleted

Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01

Henry Schein Inc. and Glove Club HSI Gloves Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.

January 17, 2024 · DrugView details →

Class IICompleted

Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15

Dr. Reddy's Laboratories, Inc.

Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.

January 2, 2024 · DrugView details →

Class ICompleted

Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp. Tarrytown, NY 10591, USA, A Prestige Consumer Healthcare company. Made in India. NDC 63736-378-02, Can UPC 3 63736 37882 0; Case UPC 1 03 63736 37882 7

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

Chemical Contamination: presence of benzene

December 21, 2023 · DrugView details →

Class IICompleted

ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239, NDC 73177-0109-26,

STAQ Pharma, Inc.

STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.

November 29, 2023 · DrugView details →

Class IICompleted

ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10

Wells Pharma of Houston LLC

Lack of assurance of sterility.

November 22, 2023 · DrugView details →

Class ICompleted

TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591, UPC 363736532611.

Insight Pharmaceuticals Corporation

Chemical Contamination; presence of benzene.

November 22, 2023 · DrugView details →

Class IIICompleted

Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Valles, Spain, Distributed by: Novartis Pharmaceuticals Corp., East Hanover, N.J. 07936, NDC 0078-1077-66

Siegfried Barbera, SL

Failed Dissolution Specifications

November 20, 2023 · DrugView details →

Class ICompleted

Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, NDC 69097-964-53

InvaGen Pharmaceuticals, Inc.

Defective Container: powder may leak out of the pouch

November 17, 2023 · DrugView details →

Class IICompleted

Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 382213, India. NDC 36000-012-25

Baxter Healthcare Corporation

Failed pH Specifications

November 14, 2023 · DrugView details →

Class IICompleted

Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01

Zydus Pharmaceuticals (USA) Inc

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

October 19, 2023 · DrugView details →

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