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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 481–500 of 1,000 recalls

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 →

Class IIITerminated

Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25.

West-Ward Columbus Inc

Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.

May 13, 2020 · DrugView details →

Class IIITerminated

Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Sciences, LLC. Lenoir, NC NDC 51754-2001-4

Exela Pharma Sciences LLC

Short Fill

May 5, 2020 · DrugView details →

Class IIITerminated

Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10

Dr. Reddy's Laboratories, Inc.

Discoloration: product contains brown pellets

April 24, 2020 · DrugView details →

Class IIITerminated

Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61

The Harvard Drug Group

Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.

April 24, 2020 · DrugView details →

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