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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 1,000 recalls

Class IITerminated

Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-34-01, UPC 8 10096 77170 4.

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-406-30

Pharmadel, LLC

cGMP deviations

April 15, 2025 · DrugView details →

Class IITerminated

DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-400-15

Pharmadel, LLC

cGMP deviations

April 15, 2025 · DrugView details →

Class IITerminated

Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-409-15

Pharmadel, LLC

cGMP deviations

April 15, 2025 · DrugView details →

Class IITerminated

Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-403-02

Pharmadel, LLC

cGMP deviations

April 15, 2025 · DrugView details →

Class IITerminated

DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15

Pharmadel, LLC

cGMP deviations

April 15, 2025 · DrugView details →

Class IIITerminated

HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01.

OurPharma LLC

Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..

April 15, 2025 · DrugView details →

Class IITerminated

Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-405-99

Pharmadel, LLC

cGMP deviations

April 15, 2025 · DrugView details →

Class IITerminated

clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01

Lupin Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.

April 10, 2025 · DrugView details →

Class IITerminated

Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY

Medisca Inc.

CGMP Deviations

March 31, 2025 · DrugView details →

Class IITerminated

Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-294-21, Unit Dose NDC 60687-294-11.

Amerisource Health Services LLC

cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.

March 24, 2025 · DrugView details →

Class IIITerminated

Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

March 4, 2025 · DrugView details →

Class IITerminated

Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50

Nephron Sterile Compounding Center LLC

Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.

February 10, 2025 · DrugView details →

Class IITerminated

Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.

RemedyRepack Inc.

CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.

January 24, 2025 · DrugView details →

Class IIITerminated

BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2

The W.S. Badger Company, Inc.

Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.

January 17, 2025 · DrugView details →

Class IITerminated

Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

January 13, 2025 · DrugView details →

Class IITerminated

Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10

Granules Pharmaceuticals Inc.

Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.

December 30, 2024 · DrugView details →

Class IITerminated

Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93

Viatris Inc

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

December 23, 2024 · DrugView details →

Class IITerminated

Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93

Viatris Inc

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

December 23, 2024 · DrugView details →

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