Civic Data
FDA RecallsUSDA RecallsAbout

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

  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 501–520 of 1,000 recalls

Class IIOngoing

Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

September 2, 2025 · DrugView details →
Class IIOngoing

bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226

Fagron Compounding Services

Lack of Assurance of Sterility

August 29, 2025 · DrugView details →
Class IOngoing

Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660

Green Lumber Holdings, LLC

Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil

August 28, 2025 · DrugView details →
Class IIIOngoing

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01

Granules Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications:

August 28, 2025 · DrugView details →
Class IIIOngoing

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01

Granules Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications:

August 28, 2025 · DrugView details →
Class IIOngoing

Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03

Ascend Laboratories, LLC

Superpotent drug

August 28, 2025 · DrugView details →
Class IIIOngoing

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01

Granules Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications:

August 28, 2025 · DrugView details →
Class IIIOngoing

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01

Granules Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications:

August 28, 2025 · DrugView details →
Class IIIOngoing

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01

Granules Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications:

August 28, 2025 · DrugView details →
Class IIOngoing

Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz (NDC 61924-304-12) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

DermaRite Industries, LLC

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

August 27, 2025 · DrugView details →
Class IIOngoing

KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34

DermaRite Industries, LLC

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

August 27, 2025 · DrugView details →
Class IIOngoing

chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11)

Amerisource Health Services LLC

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

August 27, 2025 · DrugView details →
Class IIOngoing

DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

DermaRite Industries, LLC

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

August 27, 2025 · DrugView details →
Class IIOngoing

DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08

DermaRite Industries, LLC

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

August 27, 2025 · DrugView details →
Class IIOngoing

PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08

DermaRite Industries, LLC

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

August 27, 2025 · DrugView details →
Class IIOngoing

DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04

DermaRite Industries, LLC

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

August 27, 2025 · DrugView details →
Class IIOngoing

PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

DermaRite Industries, LLC

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

August 27, 2025 · DrugView details →
Class IIOngoing

chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11)

Amerisource Health Services LLC

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

August 27, 2025 · DrugView details →
Class IIOngoing

Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04

DermaRite Industries, LLC

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

August 27, 2025 · DrugView details →
Class IIOngoing

chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11)

Amerisource Health Services LLC

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

August 27, 2025 · DrugView details →
← PreviousPage 26 of 50Next →