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 21–40 of 61 recalls

Class IIIOngoing

Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurities/Degradation Specifications

June 1, 2026 · DrugView details →

Class IIIOngoing

Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31

Sandoz Inc

Labeling: Incorrect or Missing Lot and/or Exp Date

June 1, 2026 · DrugView details →

Class IIIOngoing

Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02

Eugia US LLC

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

May 18, 2026 · DrugView details →

Class IIIOngoing

PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.

AbbVie Inc.

Failed Stability Specifications

May 18, 2026 · DrugView details →

Class IIIOngoing

Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.

AVEVA Drug Delivery Systems, Inc.

Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

May 14, 2026 · DrugView details →

Class IIIOngoing

Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)

Fresenius Kabi USA, LLC

Failed Impurities/Degradations Specifications

May 14, 2026 · DrugView details →

Class IIIOngoing

Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.

Sagent Pharmaceuticals

Failed Impurities/Degradation Specifications

May 4, 2026 · DrugView details →

Class IIIOngoing

Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11

Amerisource Health Services LLC

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

May 1, 2026 · DrugView details →

Class IIIOngoing

Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11

Amerisource Health Services LLC

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

May 1, 2026 · DrugView details →

Class IIIOngoing

Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05

Golden State Medical Supply Inc.

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

April 27, 2026 · DrugView details →

Class IIIOngoing

Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01

Golden State Medical Supply Inc.

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

April 27, 2026 · DrugView details →

Class IIIOngoing

Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.

Lannett Company Inc.

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

April 24, 2026 · DrugView details →

Class IIIOngoing

Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01

American Regent, Inc.

Labeling: Missing Label

April 16, 2026 · DrugView details →

Class IIIOngoing

Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.

Premier Dental Products Co

Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.

April 14, 2026 · DrugView details →

Class IIIOngoing

busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.

Unichem Pharmaceuticals USA Inc.

Subpotent drug

April 13, 2026 · DrugView details →

Class IIIOngoing

Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950

Water-Jel Technologies, LLC

Failed PH Specifications

April 7, 2026 · DrugView details →

Class IIIOngoing

Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-1

Avantor Performance Materials LLC

Subpotent drug

March 31, 2026 · DrugView details →

Class IIITerminated

Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13

Island Kinetics, Inc. d.b.a. CoValence Laboratories

Subpotent Drug

March 18, 2026 · DrugView details →

Class IIITerminated

Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05

Island Kinetics, Inc. d.b.a. CoValence Laboratories

Subpotent Drug

March 18, 2026 · DrugView details →

Class IIITerminated

Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04

Island Kinetics, Inc. d.b.a. CoValence Laboratories

Subpotent Drug

March 18, 2026 · DrugView details →

← PreviousPage 2 of 4Next →