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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 153 recalls

Class IIIOngoing

Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01.

Annora Pharma Private Limited

Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg

February 3, 2026 · DrugView details →

Class IIIOngoing

Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by Unichem Laboratories Limited, Plot Number 15 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa (India) 403511, NDC 29300-353-10.

Unichem Pharmaceuticals USA Inc.

Tablets/Capsules Imprinted with Wrong ID

January 21, 2026 · DrugView details →

Class IIIOngoing

Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

December 30, 2025 · DrugView details →

Class IIIOngoing

parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02

Haleon US Holdings LLC

Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.

December 26, 2025 · DrugView details →

Class IIIOngoing

Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39

Cipla USA, Inc.

Failed PH Specifications

December 22, 2025 · DrugView details →

Class IIIOngoing

traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10

Zydus Pharmaceuticals (USA) Inc

Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.

December 19, 2025 · DrugView details →

Class IIIOngoing

Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30

Alembic Pharmaceuticals Limited

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

December 16, 2025 · DrugView details →

Class IIIOngoing

Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72

NOVADOZ PHARMACEUTICALS LLC

Failed Impurities/Degradation Specifications

December 15, 2025 · DrugView details →

Class IIIOngoing

Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01.

SOMERSET THERAPEUTICS LLC

Subpotent product:out of specification assay results observed during long term stability testing.

November 26, 2025 · DrugView details →

Class IIIOngoing

Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01

Winder Laboratories, LLC

Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

November 26, 2025 · DrugView details →

Class IIIOngoing

Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.

SOMERSET THERAPEUTICS LLC

Subpotent product:out of specification assay results observed during long term stability testing.

November 26, 2025 · DrugView details →

Class IIIOngoing

Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10.

SOMERSET THERAPEUTICS LLC

Subpotent product:out of specification assay results observed during long term stability testing.

November 26, 2025 · DrugView details →

Class IIIOngoing

Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.

November 26, 2025 · DrugView details →

Class IIIOngoing

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.

Glenmark Pharmaceuticals Inc., USA

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

November 21, 2025 · DrugView details →

Class IIIOngoing

Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90.

Glenmark Pharmaceuticals Inc., USA

Cross Contamination with Other Products

November 18, 2025 · DrugView details →

Class IIIOngoing

Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56

Dr. Reddy's Laboratories, Inc.

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

November 11, 2025 · DrugView details →

Class IIIOngoing

Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.

Teva Pharmaceuticals USA, Inc

Defective Container - A defect in the side-seal which allows leakage of product.

November 7, 2025 · DrugView details →

Class IIIOngoing

Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852, NDC 71384-514-05

Imprimis NJOF, LLC

Subpotent Drug

October 20, 2025 · DrugView details →

Class IIIOngoing

Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91

Endo USA, Inc.

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

October 10, 2025 · DrugView details →

Class IIIOngoing

Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91

Endo USA, Inc.

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

October 10, 2025 · DrugView details →

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