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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 2026 recordClass II

Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Recall initiated: July 23, 2026
Reported by FDA: August 5, 2026
Distribution: Nationwide within the United States.

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Drug Recall Ongoing 2026 recordClass II

Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. NDC 42571-147-26.

by MICRO LABS USA INC

Reason: Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Recall initiated: July 22, 2026
Reported by FDA: August 5, 2026
Distribution: Nationwide in the USA.

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Drug Recall Ongoing 2026 recordClass III

Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-101-30.

by Supernus Pharmaceuticals, Inc.

Reason: Failed Dissolution Specifications
Recall initiated: July 6, 2026
Reported by FDA: July 29, 2026
Distribution: US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.

by Bionpharma Inc.

Reason: Presence of Foreign Tablets/Capsules
Recall initiated: June 26, 2026
Reported by FDA: July 29, 2026
Distribution: US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).

by Precision Dose Inc.

Reason: Failed Impurities/Degradation Specifications
Recall initiated: July 14, 2026
Reported by FDA: July 29, 2026
Distribution: US Nationwide.

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Drug Recall Ongoing 2026 recordClass III

Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.

by Ascend Laboratories, LLC

Reason: Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Recall initiated: June 30, 2026
Reported by FDA: July 29, 2026
Distribution: USA Nationwide

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Drug Recall Ongoing 2026 recordClass III

Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.

by Ascend Laboratories, LLC

Reason: Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Recall initiated: June 30, 2026
Reported by FDA: July 29, 2026
Distribution: USA Nationwide

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Drug Recall Ongoing 2026 recordClass I

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.

by JB Chemicals and Pharmaceuticals Ltd

Reason: 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.
Recall initiated: June 24, 2026
Reported by FDA: July 29, 2026
Distribution: Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03

by Fresenius Kabi USA, LLC

Reason: Presence of Particulate Matter: Hair was found in products
Recall initiated: July 16, 2026
Reported by FDA: July 29, 2026
Distribution: Nationwide within in the USA

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Drug Recall Ongoing 2026 recordClass II

Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01

by Fresenius Kabi USA, LLC

Reason: Presence of Particulate Matter: Hair was found in products
Recall initiated: July 16, 2026
Reported by FDA: July 29, 2026
Distribution: Nationwide within in the USA

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Drug Recall Ongoing 2026 recordClass II

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05

by Fresenius Kabi USA, LLC

Reason: Presence of Particulate Matter: Hair was found in products
Recall initiated: July 16, 2026
Reported by FDA: July 29, 2026
Distribution: Nationwide within in the USA

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Drug Recall Ongoing 2026 recordClass II

Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01

by Fresenius Kabi USA, LLC

Reason: Presence of Particulate Matter: Hair was found in products
Recall initiated: July 16, 2026
Reported by FDA: July 29, 2026
Distribution: Nationwide within in the USA

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Drug Recall Ongoing 2026 recordClass II

Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07

by Fresenius Kabi USA, LLC

Reason: Presence of Particulate Matter: Hair was found in product
Recall initiated: July 16, 2026
Reported by FDA: July 29, 2026
Distribution: Nationwide within in the USA

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Drug Recall Ongoing 2026 recordClass II

Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton, MA. NDC 64980-504-48.

by Rising Pharma Holding, Inc.

Reason: Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Recall initiated: July 13, 2026
Reported by FDA: July 29, 2026
Distribution: Nationwide U.S.A.

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Drug Recall Ongoing 2026 recordClass II

Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1

by Rohto-Mentholatum (Vietnam) Co., Ltd.

Reason: Lack of Assurance of Sterility
Recall initiated: July 14, 2026
Reported by FDA: July 29, 2026
Distribution: Nationwide within the United States

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Drug Recall Ongoing 2026 recordClass II

Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2

by Rohto-Mentholatum (Vietnam) Co., Ltd.

Reason: Lack of Assurance of Sterility
Recall initiated: July 14, 2026
Reported by FDA: July 29, 2026
Distribution: Nationwide within the United States

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Drug Recall Ongoing 2026 recordClass II

Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1

by Rohto-Mentholatum (Vietnam) Co., Ltd.

Reason: Lack of Assurance of Sterility
Recall initiated: July 14, 2026
Reported by FDA: July 29, 2026
Distribution: Nationwide within the United States

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Drug Recall Ongoing 2026 recordClass II

Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1

by Rohto-Mentholatum (Vietnam) Co., Ltd.

Reason: Lack of Assurance of Sterility
Recall initiated: July 14, 2026
Reported by FDA: July 29, 2026
Distribution: Nationwide within the United States

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Drug Recall Ongoing 2026 recordClass II

Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1

by Rohto-Mentholatum (Vietnam) Co., Ltd.

Reason: Lack of Assurance of Sterility
Recall initiated: July 14, 2026
Reported by FDA: July 29, 2026
Distribution: Nationwide within the United States

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Drug Recall Ongoing 2026 recordClass II

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2

by Rohto-Mentholatum (Vietnam) Co., Ltd.

Reason: Lack of Assurance of Sterility
Recall initiated: July 14, 2026
Reported by FDA: July 29, 2026
Distribution: Nationwide within the United States

View recall →

Data last updated: October 29, 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.