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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 501–520 of 1,000 recalls

Class IIITerminated

Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Acid 2.0%), 6 fl oz,; Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 fl oz., Distributed in the U.S.A. by Allergan, Irvine, CA 92612, UPC 300234966005

Allergan PLC

SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.

July 6, 2020 · DrugView details →

Class IIITerminated

Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612, NDC 0023-4965-02

Allergan PLC

SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.

July 6, 2020 · DrugView details →

Class IIITerminated

Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86

SUN PHARMACEUTICAL INDUSTRIES INC

Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine

July 6, 2020 · DrugView details →

Class IIITerminated

Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02

Biogen MA Inc.

cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.

June 23, 2020 · DrugView details →

Class IIITerminated

Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.

VistaPharm, Inc.

Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.

June 23, 2020 · DrugView details →

Class IIITerminated

Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.

VistaPharm, Inc.

Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.

June 23, 2020 · DrugView details →

Class IIITerminated

Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Distributed by HF Acquisition Co, LLC, Mukilteo, WA 98275, NDC 63323-739-12

HF Acquisition Co. LLC

TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.

June 17, 2020 · DrugView details →

Class IIITerminated

Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC carton: 60687-374-01, NDC unit dose: 60687-374-11

American Health Packaging

Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.

June 10, 2020 · DrugView details →

Class IIITerminated

Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-040-04

Akorn, Inc.

Discoloration: Out of Specification (OOS) result for APHA Color Test.

June 5, 2020 · DrugView details →

Class IIITerminated

Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-232-01

SOMERSET THERAPEUTICS LLC

Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.

June 4, 2020 · DrugView details →

Class IIITerminated

Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01

SOMERSET THERAPEUTICS LLC

Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.

June 4, 2020 · DrugView details →

Class IIITerminated

Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-231-01

SOMERSET THERAPEUTICS LLC

Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.

June 4, 2020 · DrugView details →

Class IIITerminated

Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.

AVKARE Inc.

Presence of Foreign Substance consistent with granules from desiccant packs used during storage

May 28, 2020 · DrugView details →

Class IIITerminated

Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distributed by Wyeth Pharmaceuticals LLC A subsidiary of Pfizer In Philadelphia, PA 19101 Made in Ireland, NDC 00008-1123-12

Pfizer Inc.

Failed Dissolution Specifications

May 27, 2020 · DrugView details →

Class IIITerminated

Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30

Aurobindo Pharma USA Inc.

Failed Impurities/ Degradation Specifications

May 26, 2020 · DrugView details →

Class IIITerminated

Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for : Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-135-01

UNICHEM PHARMACEUTICALS USA INC

Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.

May 26, 2020 · DrugView details →

Class IIITerminated

Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30

Aurobindo Pharma USA Inc.

Failed Impurities/ Degradation Specifications

May 26, 2020 · DrugView details →

Class IIITerminated

Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA, For repackaging by: AvKare Inc., Pulaski, TN 38478, Bulk Shipment, NDC 59746-247-97.

Jubilant Cadista Pharmaceuticals, Inc.

Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.

May 26, 2020 · DrugView details →

Class IIITerminated

Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufactured for: Flexion Therapeutics, Inc. 10 Mall Road, Suite 301, Burlington, MA 01803, NDC 70801-003-01

Flexion Therapeutics, Inc.

Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded

May 19, 2020 · DrugView details →

Class IIITerminated

Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05.

InvaGen Pharmaceuticals, Inc.

Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.

May 14, 2020 · DrugView details →

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