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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 581–600 of 1,000 recalls

Class IITerminated

SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →

Class IITerminated

Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →

Terminated

StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →

Class IITerminated

Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →

Class IITerminated

StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →

Class IITerminated

StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →

Class IITerminated

DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →

Class IITerminated

StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →

Class IITerminated

Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02

Homeocare Laboratories, Inc.

cGMP deviations

June 5, 2023 · DrugView details →

Class ITerminated

ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6269-08

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.

May 31, 2023 · DrugView details →

Class IITerminated

Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.

Amneal Pharmaceuticals of New York, LLC

Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)

May 30, 2023 · DrugView details →

Class IITerminated

Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti, Halol-389350, Gujarat, India, NDC 62756-0233-01

SUN PHARMACEUTICAL INDUSTRIES INC

Subpotent drug

May 30, 2023 · DrugView details →

Class IITerminated

Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05

Viatris Inc

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

May 25, 2023 · DrugView details →

Class IITerminated

Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactured by: GSMS Incorporated, Camarillo, CA 93012, a) NDC 51407-731-25 (2.5 mL bottle), b) NDC 51407-731-05 (5 mL bottle).

Golden State Medical Supply Inc.

Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.

May 25, 2023 · DrugView details →

Class IITerminated

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10

Fresenius Medical Care Holdings, Inc.

Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.

May 23, 2023 · DrugView details →

Class IIITerminated

Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25

New England Life Care, Inc. dba Advanced Compounding Solutions

Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

May 22, 2023 · DrugView details →

Class IIITerminated

Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

May 18, 2023 · DrugView details →

Class IITerminated

FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park, Pittsburgh, PA 15238,

Alpha Aromatics

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

May 16, 2023 · DrugView details →

Class IITerminated

Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-004-51

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →

Class IITerminated

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →

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