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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 21–40 of 359 recalls

Class IICompleted

Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01

Dercher Enterprises, Inc., DBA Gordon Laboratories

cGMP Deviations

April 12, 2024 · DrugView details →

Class IICompleted

Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.

Amneal Pharmaceuticals of New York, LLC

Failed Dissolution Specifications

March 25, 2024 · DrugView details →

Class IICompleted

Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01

Eli Lilly & Company

CGMP Deviations

March 12, 2024 · DrugView details →

Class IICompleted

S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03

Specialty Process Labs LLC

Failed Stability Specifications

March 1, 2024 · DrugView details →

Class IICompleted

S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.

Specialty Process Labs LLC

Failed Stability Specifications

March 1, 2024 · DrugView details →

Class IICompleted

Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Rx Only, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, NDC 68682-991-30.

Bausch Health Companies, Inc.

Subpotent Drug: Out of specification for assay

February 2, 2024 · DrugView details →

Class IICompleted

Lurasidone Hydrochloride Tablets 60mg, 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 47335-639-83.

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 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 · DrugView 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 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 →

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