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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 1,541–1,560 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1203-03

by RemedyRePack Inc.

Reason
CGMP Deviations: Out of specification for dissolution
Recall initiated
June 26, 2024
Reported by FDA
July 24, 2024
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-143-16

by Homeocare Laboratories, Inc.

Reason
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Recall initiated
June 5, 2024
Reported by FDA
July 24, 2024
Distribution
Nationwide to 60 Physician offices

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Drug Recall Terminated Historical recordClass I

STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01

by Homeocare Laboratories, Inc.

Reason
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Recall initiated
June 5, 2024
Reported by FDA
July 24, 2024
Distribution
Nationwide to 60 Physician offices

View recall →

Drug Recall Ongoing Historical recordClass II

DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94

by Fresenius Medical Care Holdings, Inc.

Reason
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Recall initiated
June 18, 2024
Reported by FDA
July 24, 2024
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Recall initiated
May 30, 2024
Reported by FDA
July 24, 2024
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-01

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Recall initiated
May 30, 2024
Reported by FDA
July 24, 2024
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass I

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05

by Glenmark Pharmaceuticals Inc., USA

Reason
Failed Dissolution Specifications
Recall initiated
May 30, 2024
Reported by FDA
July 24, 2024
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass I

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-01

by Glenmark Pharmaceuticals Inc., USA

Reason
Failed Dissolution Specifications
Recall initiated
May 30, 2024
Reported by FDA
July 24, 2024
Distribution
Nationwide

View recall →

Drug Recall Completed Historical recordClass II

Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10

by Viatris Inc

Reason
Failed Impurities/Degradation Specifications
Recall initiated
April 30, 2024
Reported by FDA
July 24, 2024
Distribution
U.S. Nationwide

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Drug Recall Completed Historical recordClass II

Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10

by Viatris Inc

Reason
Failed Impurities/Degradation Specifications
Recall initiated
April 30, 2024
Reported by FDA
July 24, 2024
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0997-02.

by Teva Pharmaceuticals USA, Inc

Reason
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Recall initiated
June 28, 2024
Reported by FDA
July 24, 2024
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd. in India, NDC 16714-165-01.

by Zydus Pharmaceuticals (USA) Inc

Reason
Presence of particulate matter: glass
Recall initiated
June 27, 2024
Reported by FDA
July 24, 2024
Distribution
TN

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Drug Recall Ongoing Historical recordClass II

Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per case, Manufactured By:/Fabrique Par: , Brands International Corp., Newmarket, ON, L3X 2S2, Made in Canada.

by Brands International Corporation

Reason
Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Recall initiated
June 10, 2024
Reported by FDA
July 24, 2024
Distribution
USA nationwide.

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Drug Recall Terminated Historical recordClass II

Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun - 248-197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-233-88.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Dissolution Specifications
Recall initiated
July 9, 2024
Reported by FDA
July 24, 2024
Distribution
Nationwide in the USA and Puerto rico

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Drug Recall Ongoing Historical recordClass III

Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60

by Rising Pharma Holding, Inc.

Reason
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Recall initiated
June 24, 2024
Reported by FDA
July 17, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Completed Historical recordClass III

Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-01 (vial), NDC 16714-301-10 (outer box).

by Zydus Pharmaceuticals (USA) Inc

Reason
Cross contamination with other products
Recall initiated
July 2, 2024
Reported by FDA
July 17, 2024
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Completed Historical recordClass III

Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box).

by Zydus Pharmaceuticals (USA) Inc

Reason
Cross contamination with other products
Recall initiated
July 2, 2024
Reported by FDA
July 17, 2024
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2

by Tailstorm Health INC

Reason
Subpotent Drug: reduced efficacy for epinephrine
Recall initiated
July 3, 2024
Reported by FDA
July 17, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass III

Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534, Vial NDC: 70710-1644-1, Carton NDC: 70710-1644-5.

by Zydus Pharmaceuticals (USA) Inc

Reason
Cross contamination with other products.
Recall initiated
July 2, 2024
Reported by FDA
July 17, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass III

Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-7; (b) 5x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-5; Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534,

by Zydus Pharmaceuticals (USA) Inc

Reason
Cross contamination with other products.
Recall initiated
July 2, 2024
Reported by FDA
July 17, 2024
Distribution
Nationwide in the USA

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.