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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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Drug Recall Ongoing Historical recordClass II

Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52.

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations
Recall initiated: July 22, 2024
Reported by FDA: August 7, 2024
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass I

Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.

by SoloVital

Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Recall initiated: July 12, 2024
Reported by FDA: August 7, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass I

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India. Distributed for: BluePoint Laboratories.

by Amerisource Health Services LLC

Reason: Failed Dissolution Specifications
Recall initiated: June 25, 2024
Reported by FDA: August 7, 2024
Distribution: US Nationwide.

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Drug Recall Terminated Historical recordClass III

Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of homeopathic medicines, Washington Homeopathic Products, Inc., Berkley Springs, WV 25411, UPC 7 40640 64300 6.

by Washington Homeopathic Products, Inc.

Reason: Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.
Recall initiated: May 31, 2024
Reported by FDA: July 31, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Recall initiated: June 21, 2024
Reported by FDA: July 31, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass III

Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC Code: 8-40078-56612-7

by GLOBAL WIDGET LLC

Reason: Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Recall initiated: June 25, 2024
Reported by FDA: July 31, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass III

Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC code: 8-40078-56497-0

by GLOBAL WIDGET LLC

Reason: Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Recall initiated: June 25, 2024
Reported by FDA: July 31, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass III

Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, UPC code: 8-40078-56731-5

by GLOBAL WIDGET LLC

Reason: Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Recall initiated: June 25, 2024
Reported by FDA: July 31, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass III

Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, NDC 73423-003-01; UPC Code: 8-40078-56493-2

by GLOBAL WIDGET LLC

Reason: Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Recall initiated: June 25, 2024
Reported by FDA: July 31, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,

by Glenmark Pharmaceuticals Inc., USA

Reason: Failed Dissolution Specifications: results below specifications
Recall initiated: June 28, 2024
Reported by FDA: July 24, 2024
Distribution: USA Nationwide

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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

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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

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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

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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

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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

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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

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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

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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

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Data last updated: October 31, 2026 ET

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.