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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 1–20 of 1,000 recalls

Class ITerminated

Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)

Amneal Pharmaceuticals, LLC

Presence of Particulate Matter

April 17, 2025 · DrugView details →

Class ITerminated

Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317

Staska Pharmaceuticals, Inc.

Presence of Particulate Matter: Presence of glass particulates.

September 30, 2024 · DrugView details →

Class ITerminated

Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2

Gilead Sciences, Inc.

Presence of Particulate Matter: Presence of glass particle.

September 19, 2024 · DrugView details →

Class ITerminated

Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.

Bionpharma Inc.

Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.

September 17, 2024 · DrugView details →

Class ITerminated

Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.

Endo Pharmaceuticals, Inc.

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.

July 10, 2024 · DrugView details →

Class ITerminated

Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2

A-S Medication Solutions LLC

Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.

June 21, 2024 · DrugView details →

Class ITerminated

STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01

Homeocare Laboratories, Inc.

Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms

June 5, 2024 · DrugView details →

Class ITerminated

Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV.

Stop Clopez Corp

Marketed Without An Approved NDA/ANDA

April 22, 2024 · DrugView details →

Class ITerminated

Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.

AvKARE

Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.

March 28, 2024 · DrugView details →

Class ITerminated

Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807

Amneal Pharmaceuticals of New York, LLC

Superpotent Drug: Due to overfilling of drug powder

March 21, 2024 · DrugView details →

Class ITerminated

ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.

FA Online Inc

Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.

February 12, 2024 · DrugView details →

Class ITerminated

Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.

Super Chill Products

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

February 5, 2024 · DrugView details →

Class ITerminated

Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03

Azurity Pharmaceuticals, Inc.

Labeling: Label Mix-up

January 4, 2024 · DrugView details →

Class ITerminated

Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

Haleon US Holdings LLC

Microbial Contamination of Non-Sterile Products

December 26, 2023 · DrugView details →

Class ITerminated

Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

Haleon US Holdings LLC

Microbial Contamination of Non-Sterile Products

December 26, 2023 · DrugView details →

Class ITerminated

VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01

Bayer Healthcare Pharmaceuticals Inc.

Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing

November 6, 2023 · DrugView details →

Class ITerminated

Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

October 31, 2023 · DrugView details →

Class ITerminated

Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

October 31, 2023 · DrugView details →

Class ITerminated

Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Failed Content Uniformity Specifications

October 23, 2023 · DrugView details →

Class ITerminated

Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771 USA, NDC 66689-305-16

VistaPharm LLC

Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.

October 18, 2023 · DrugView details →

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