Civic Data
FDA RecallsAbout

FDA Recalls

  • Food recalls
  • Drug recalls
  • Device recalls

Browse

  • All recalls

About

  • About us
  • Guides
  • Data sources
  • Privacy policy

Data

  • OpenFDA API

© 2026Civic Data · Data sourced from OpenFDA, updated weekly · Not affiliated with the U.S. Food and Drug Administration · Always verify against official FDA 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 141–160 of 1,000 recalls

Class IITerminated

Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6

Amneal Pharmaceuticals of New York, LLC

Failed Impurities/Degradation Specifications: Out-of-specification test results.

February 13, 2024 · DrugView details →
Class IITerminated

CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807 USA, Manufactured by: Bausch Health Companies, Inc. Laval Quebec H7L 448, Canada, NDC 0187-0006-25.

MCKESSON CORPORATION

CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.

February 12, 2024 · Drug
View details →
Class IITerminated

HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.

February 9, 2024 · DrugView details →
Class IITerminated

Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873, NDC 42571-227-30.

Micro Labs Limited

Failed Stability Specifications: Out of specification for blend uniformity.

February 9, 2024 · DrugView details →
Class IITerminated

Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10

Mckesson Medical-Surgical Inc. Corporate Office

cGMP Deviations: Products were stored outside the drug label specifications.

February 7, 2024 · DrugView details →
Class IITerminated

Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10

Mckesson Medical-Surgical Inc. Corporate Office

cGMP Deviations: Products were stored outside the drug label specifications.

February 7, 2024 · DrugView details →
Class IITerminated

Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01

Mckesson Medical-Surgical Inc. Corporate Office

cGMP Deviations: Products were stored outside the drug label specifications.

February 7, 2024 · DrugView details →
Class IITerminated

Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202. NDC: 43386-038-60.

Lupin Pharmaceuticals Inc.

Labeling: Incorrect or Missing Package Insert

February 5, 2024 · DrugView details →
Class IITerminated

Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41

NATCO Pharma Limited

CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.

February 1, 2024 · DrugView details →
Class IITerminated

Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11

Amerisource Health Services LLC

CGMP Deviations

January 25, 2024 · DrugView details →
Class IITerminated

Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park, Pittsburg, PA 15238 USA, www.airscent.com, NDC 75009-562.

Alpha Aromatics

CGMP Deviations

January 25, 2024 · DrugView details →
Class IITerminated

CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

Bestco LLC

CGMP Deviations: Potential Glass and Silicone particulates in product

January 19, 2024 · DrugView details →
Class IITerminated

Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

Bestco LLC

CGMP Deviations: Potential Glass and Silicone particulates in product

January 19, 2024 · DrugView details →
Class IITerminated

Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

Bestco LLC

CGMP Deviations: Potential Glass and Silicone particulates in product

January 19, 2024 · DrugView details →
Class IITerminated

Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, item number 20000463, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

Bestco LLC

CGMP Deviations: Potential Glass and Silicone particulates in product

January 19, 2024 · DrugView details →
Class IITerminated

Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials

OMEZA LLC

CGMP Deviations

January 19, 2024 · DrugView details →
Class IITerminated

Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS

OMEZA LLC

CGMP Deviations

January 19, 2024 · DrugView details →
Class IITerminated

Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

Bestco LLC

CGMP Deviations: Potential Glass and Silicone particulates in product

January 19, 2024 · DrugView details →
Class IITerminated

Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01

Amneal Pharmaceuticals of New York, LLC

Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

January 15, 2024 · DrugView details →
Class IITerminated

Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30

Golden State Medical Supply Inc.

Failed Dissolution Specifications

January 12, 2024 · DrugView details →
← PreviousPage 8 of 50Next →