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© 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 161–180 of 1,000 recalls

Class IIITerminated

Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20

Novitium Pharma LLC

Cross Contamination with Other Products:(mycophenolate mofetil).

March 4, 2024 · DrugView details →
Class IITerminated

Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470-06, Vial NDC 55150-470-01.

Eugia US LLC

Failed Stability Specification: Water determination was found not complying with specification.

February 22, 2024 · DrugView details →
Class IITerminated

PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471

Seatex LLC

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

February 19, 2024 · DrugView details →
Class IITerminated

PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471

Seatex LLC

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

February 19, 2024 · DrugView details →
Class IITerminated

7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033

Seatex LLC

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

February 19, 2024 · DrugView details →
Class IITerminated

PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471.

Seatex LLC

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

February 19, 2024 · DrugView details →
Class IITerminated

7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033

Seatex LLC

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

February 19, 2024 · DrugView details →
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 · DrugView details →
Class ITerminated

ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.

FA Online Inc

Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.

February 12, 2024 · DrugView details →
Class IIITerminated

Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com

Stason Pharmaceuticals, Inc.

Failed Dissolution Specifications: results slightly under spec at at 9-months.

February 9, 2024 · DrugView 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 ITerminated

Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.

Super Chill Products

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

February 5, 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 →
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