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© 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 221–240 of 1,000 recalls

Class IIOngoing

FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320.

Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

June 25, 2026 · DrugView details →

Class IIOngoing

CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.

Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

June 25, 2026 · DrugView details →

Class IIOngoing

meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.

Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

June 25, 2026 · DrugView details →

Class IIOngoing

CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,

Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

June 25, 2026 · DrugView details →

Class IIOngoing

TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.

Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

June 25, 2026 · DrugView details →

Class IIOngoing

AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.

Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

June 25, 2026 · DrugView details →

Class IIOngoing

GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428.

Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

June 25, 2026 · DrugView details →

Class IIOngoing

Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.

Bell Pharmaceuticals, Inc

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

June 25, 2026 · DrugView details →

Class IIOngoing

Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01

Reliance Life Sciences Private Limited

Lack of Sterility Assurance

June 24, 2026 · DrugView details →

Class IIOngoing

Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01

Reliance Life Sciences Private Limited

Lack of Sterility Assurance

June 24, 2026 · DrugView details →

Class IIOngoing

Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01

Reliance Life Sciences Private Limited

Lack of Sterility Assurance

June 24, 2026 · DrugView details →

Class IIOngoing

Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01

Reliance Life Sciences Private Limited

Lack of Sterility Assurance

June 24, 2026 · DrugView details →

Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.

JB Chemicals and Pharmaceuticals Ltd

Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.

June 24, 2026 · DrugView details →

Class IIOngoing

Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.

QuVa Pharma, Inc.

Failed Impurities/Degradation Specifications

June 24, 2026 · DrugView details →

Class IIOngoing

Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-311-01

Lupin Pharmaceuticals Inc.

CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.

June 23, 2026 · DrugView details →

Class IIOngoing

Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35

Padagis US LLC

Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

June 23, 2026 · DrugView details →

Class IIOngoing

DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.

Direct Rx

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

June 22, 2026 · DrugView details →

Class IIOngoing

Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206-6

SUN PHARMACEUTICAL INDUSTRIES INC

Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.

June 17, 2026 · DrugView details →

Class IIOngoing

Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 46268, NDC 0904-7282-10. Blister Label: Methylergonovine Maleate Tablets, 0.2 mg, USP, One Tablet, Major Pharm/Indianapolis, IN 46268, NDC 0904-7282-10.

The Harvard Drug Group LLC

Subpotent Drug

June 16, 2026 · DrugView details →

Class IIOngoing

Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45

Boehringer Ingelheim Pharmaceuticals, Inc.

CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.

June 12, 2026 · DrugView details →

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