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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 101–120 of 1,000 recalls

Class IITerminated

Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tube NDC:53228-003-01 b) 4 OZ 118ML plastic bottle, UPC 7 01450 90008 6, NDC # 53228-002-01, Equibal Labs, Inc

Equibal Inc

CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.

June 26, 2024 · DrugView details →

Class IITerminated

Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534

Zydus Pharmaceuticals (USA) Inc

Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.

June 21, 2024 · DrugView details →

Class IITerminated

Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, USA, NDC 0904-7075-61, UPC code: 309047075614

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.

June 18, 2024 · DrugView details →

Class IITerminated

Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10

Trigen Laboratories

Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.

June 17, 2024 · DrugView details →

Class IITerminated

Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106 USA, NDC 55111-730-01.

Dr. Reddy's Laboratories, Inc.

Presence of foreign substance.

June 7, 2024 · DrugView details →

Class IITerminated

STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-143-16

Homeocare Laboratories, Inc.

Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism

June 5, 2024 · DrugView details →

Class IITerminated

Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GA

RemedyRepack Inc.

Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

May 31, 2024 · DrugView details →

Class IITerminated

Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC 68180-407-03

Lupin Pharmaceuticals Inc.

Failed Content Uniformity Specifications

May 30, 2024 · DrugView details →

Class IITerminated

Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following brands - Rite Aid, with UPC 0-11822-51349-4; Kroger, with UPC 0-41260-35275-1; Harris Teeter, with UPC 0-72036-75051-8; CVS, with UPC 0-50428-31702-0

Consumer Product Partners, LLC

Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile

May 28, 2024 · DrugView details →

Class IITerminated

Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02

Denison Pharmaceuticals, LLC

cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.

May 28, 2024 · DrugView details →

Class IITerminated

Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64

Genentech, Inc.

Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.

May 20, 2024 · DrugView details →

Class IITerminated

Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90

Breckenridge Pharmaceutical, Inc

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

May 17, 2024 · DrugView details →

Class IITerminated

EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01, NDC (sample lot) 61755-005-54

Regeneron Pharmaceuticals Inc

Lack of Assurance of Sterility: Complaints of syringe breakage

May 15, 2024 · DrugView details →

Class IITerminated

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10

American Regent, Inc.

Lack of Assurance of Sterility.

May 14, 2024 · DrugView details →

Class IITerminated

Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01

American Regent, Inc.

Subpotent product in addition to having out-of-specification results for impurities.

May 13, 2024 · DrugView details →

Class IITerminated

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.

Golden State Medical Supply Inc.

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.

May 13, 2024 · DrugView details →

Class IITerminated

Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04

Lupin Pharmaceuticals Inc.

Defective container: lack of seal integrity.

May 8, 2024 · DrugView details →

Class IITerminated

TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762

RemedyRepack Inc.

Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol

May 2, 2024 · DrugView details →

Class IITerminated

Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ

FDC Limited

Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.

April 25, 2024 · DrugView details →

Class IITerminated

Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04

Lupin Pharmaceuticals Inc.

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

April 24, 2024 · DrugView details →

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