FDA Recalls USDA Recalls About

FDA Recalls

Food recalls
Drug recalls
Device recalls

USDA Recalls

All USDA recalls
Poultry recalls
Meat recalls
Egg recalls

About

About us
FDA guides
USDA guides
Data sources
Privacy policy

Data

OpenFDA API
USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

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 781–800 of 1,000 recalls

Class IIOngoing

Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02

Strides Pharma, Inc.

Presence of foreign substance: Presence of Benzene.

March 5, 2025 · DrugView details →

Class IIOngoing

PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30

Golden State Medical Supply Inc.

Failed Dissolution Specifications

March 5, 2025 · DrugView details →

Class IIOngoing

Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99

Rising Pharma Holding, Inc.

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

March 5, 2025 · DrugView details →

Class IIOngoing

Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02

Strides Pharma, Inc.

Presence of foreign substance: Presence of Benzene.

March 5, 2025 · DrugView details →

Class IIOngoing

Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0

Chattem Inc

CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.

March 4, 2025 · DrugView details →

Class IIOngoing

Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

February 28, 2025 · DrugView details →

Class IIOngoing

Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

February 28, 2025 · DrugView details →

Class IIOngoing

Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

February 28, 2025 · DrugView details →

Class IIOngoing

Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

February 28, 2025 · DrugView details →

Class IIOngoing

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05

Breckenridge Pharmaceutical, Inc.

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

February 28, 2025 · DrugView details →

Class IIOngoing

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10

Breckenridge Pharmaceutical, Inc.

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

February 28, 2025 · DrugView details →

Class IIOngoing

Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10

Breckenridge Pharmaceutical, Inc.

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

February 28, 2025 · DrugView details →

Class IIOngoing

Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8

Sigan Industries Group Inc.

Chemical Contamination: Presence of benzene

February 28, 2025 · DrugView details →

Class IIOngoing

Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial), NDC 55513-530-10 (box).

Amgen, Inc.

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

February 27, 2025 · DrugView details →

Class IIOngoing

Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc. Thousand Oaks, CA 91320, NDC 55513-546-01 (vial), NDC 55513-546-10 (box).

Amgen, Inc.

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

February 27, 2025 · DrugView details →

Class IIOngoing

METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.

A-S Medication Solutions LLC

Presence of Foreign Tablets/Capsules.

February 25, 2025 · DrugView details →

Class IIOngoing

Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93

MYLAN PHARMACEUTICALS INC

Failed Dissolution Specifications - low dissolution results

February 25, 2025 · DrugView details →

Class IIOngoing

Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1

Denison Pharmaceuticals, LLC

Chemical Contamination: Presence of benzene.

February 24, 2025 · DrugView details →

Class IIOngoing

Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302.

Safecor Health, LLC

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

February 17, 2025 · DrugView details →

Class IIOngoing

CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30.

MEDLINE INDUSTRIES, LP - Northfield

Subpotent Drug

February 17, 2025 · DrugView details →

← PreviousPage 40 of 50Next →