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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 I

ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance, UPC X004BB9Z8N

by EnShiShiXiangNiShangMaoYouXianGongSi

Reason: Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
Recall initiated: May 6, 2025
Reported by FDA: June 4, 2025
Distribution: Nationwide Via Amazon Platform

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Drug Recall Ongoing Historical recordClass II

Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-356-01

by Glenmark Pharmaceuticals Inc., USA

Reason: OOS results reported for the Dissolution (by UV) test.
Recall initiated: May 15, 2025
Reported by FDA: June 4, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Recall initiated: February 28, 2025
Reported by FDA: June 4, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Recall initiated: February 28, 2025
Reported by FDA: June 4, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Recall initiated: February 28, 2025
Reported by FDA: June 4, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Recall initiated: February 28, 2025
Reported by FDA: June 4, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17

by Alembic Pharmaceuticals Limited

Reason: Failed Impurities/Degradation Specifications
Recall initiated: May 7, 2025
Reported by FDA: June 4, 2025
Distribution: US Nationwide

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Drug Recall Ongoing Historical recordClass II

Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01.

by KVK Tech, Inc.

Reason: cGMP deviations
Recall initiated: May 9, 2025
Reported by FDA: May 28, 2025
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.

by KVK Tech, Inc.

Reason: cGMP deviations
Recall initiated: May 9, 2025
Reported by FDA: May 28, 2025
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France, .

by AsttraZeneca Pharmaceuticals LP

Reason: Defective delivery system
Recall initiated: May 14, 2025
Reported by FDA: May 28, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Recall initiated: May 13, 2025
Reported by FDA: May 28, 2025
Distribution: Nationwide -in the USA

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Drug Recall Ongoing Historical recordClass II

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Recall initiated: May 13, 2025
Reported by FDA: May 28, 2025
Distribution: Nationwide -in the USA

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Drug Recall Ongoing Historical recordClass II

BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.

by CareFusion 213, LLC

Reason: Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Recall initiated: May 15, 2025
Reported by FDA: May 28, 2025
Distribution: Nationwide in the U.S.

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Drug Recall Terminated Historical recordClass II

Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-05

by KENIL HEALTHCARE PRIVATE LIMITED

Reason: CGMP Deviations
Recall initiated: April 24, 2025
Reported by FDA: May 28, 2025
Distribution: DE and NC

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Drug Recall Terminated Historical recordClass II

Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-04

by KENIL HEALTHCARE PRIVATE LIMITED

Reason: CGMP Deviations
Recall initiated: April 24, 2025
Reported by FDA: May 28, 2025
Distribution: DE and NC

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Drug Recall Terminated Historical recordClass II

Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-03

by KENIL HEALTHCARE PRIVATE LIMITED

Reason: CGMP Deviations
Recall initiated: April 24, 2025
Reported by FDA: May 28, 2025
Distribution: DE and NC

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Drug Recall Terminated Historical recordClass II

Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 6.4 OZ (181 grams) Box, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-07

by KENIL HEALTHCARE PRIVATE LIMITED

Reason: CGMP Deviations
Recall initiated: April 24, 2025
Reported by FDA: May 28, 2025
Distribution: DE and NC

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Drug Recall Terminated Historical recordClass II

Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-02

by KENIL HEALTHCARE PRIVATE LIMITED

Reason: CGMP Deviations
Recall initiated: April 24, 2025
Reported by FDA: May 28, 2025
Distribution: DE and NC

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Drug Recall Terminated Historical recordClass II

Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 4.6 OZ (130 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-06

by KENIL HEALTHCARE PRIVATE LIMITED

Reason: CGMP Deviations
Recall initiated: April 24, 2025
Reported by FDA: May 28, 2025
Distribution: DE and NC

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Drug Recall Terminated Historical recordClass II

Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5 OZ (43 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-04

by KENIL HEALTHCARE PRIVATE LIMITED

Reason: CGMP Deviations
Recall initiated: April 24, 2025
Reported by FDA: May 28, 2025
Distribution: DE and NC

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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.