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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

Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.

by Teva Pharmaceuticals USA, Inc

Reason: Failed Dissolution Specifications
Recall initiated: January 29, 2026
Reported by FDA: March 11, 2026
Distribution: Nationwide

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Drug Recall Ongoing 2026 recordClass II

Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

by Teva Pharmaceuticals USA, Inc

Reason: Failed Dissolution Specifications
Recall initiated: January 29, 2026
Reported by FDA: March 11, 2026
Distribution: Nationwide

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Drug Recall Ongoing 2026 recordClass II

Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

by Teva Pharmaceuticals USA, Inc

Reason: Failed Dissolution Specifications
Recall initiated: January 29, 2026
Reported by FDA: March 11, 2026
Distribution: Nationwide

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Drug Recall Ongoing 2026 recordClass II

BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.

by Wizcure Pharmaa Private Limited

Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Recall initiated: December 31, 2025
Reported by FDA: March 4, 2026
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.

by Wizcure Pharmaa Private Limited

Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Recall initiated: December 31, 2025
Reported by FDA: March 4, 2026
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,

by Wizcure Pharmaa Private Limited

Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Recall initiated: December 31, 2025
Reported by FDA: March 4, 2026
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.

by Wizcure Pharmaa Private Limited

Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Recall initiated: December 31, 2025
Reported by FDA: March 4, 2026
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10.

by Wizcure Pharmaa Private Limited

Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Recall initiated: December 31, 2025
Reported by FDA: March 4, 2026
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.

by Wizcure Pharmaa Private Limited

Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Recall initiated: December 31, 2025
Reported by FDA: March 4, 2026
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.

by Wizcure Pharmaa Private Limited

Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Recall initiated: December 31, 2025
Reported by FDA: March 4, 2026
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027

by Agebox

Reason: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Recall initiated: October 28, 2025
Reported by FDA: March 4, 2026
Distribution: The product was distributed nationwide in the U.S. Agebox sells its U.S. products through Agebox.com (using Shopify) and Amazon.com. All orders are shipped to customers by Agebox itself; other parties are not involved in the distribution of the physical product.

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Drug Recall Ongoing 2026 recordClass II

Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0

by Agebox

Reason: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Recall initiated: October 28, 2025
Reported by FDA: March 4, 2026
Distribution: The product was distributed nationwide in the U.S. Agebox sells its U.S. products through Agebox.com (using Shopify) and Amazon.com. All orders are shipped to customers by Agebox itself; other parties are not involved in the distribution of the physical product.

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Drug Recall Ongoing 2026 recordClass III

Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80

by Slate Run Pharmaceuticals

Reason: Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Recall initiated: February 12, 2026
Reported by FDA: March 4, 2026
Distribution: Nationwide within the USA.

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Drug Recall Ongoing 2026 recordClass II

Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.

by AvKARE

Reason: Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Recall initiated: February 13, 2026
Reported by FDA: March 4, 2026
Distribution: Nationwide in the USA.

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Drug Recall Ongoing 2026 recordClass II

Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,

by LEO PHARMA INC

Reason: Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
Recall initiated: February 10, 2026
Reported by FDA: March 4, 2026
Distribution: Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass I

UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63

by McKesson

Reason: Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
Recall initiated: January 16, 2026
Reported by FDA: February 18, 2026
Distribution: Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.

by Meitheal Pharmaceuticals, Inc

Reason: Defective Delivery System: Missing or duplicated needles within the injection kit
Recall initiated: February 9, 2026
Reported by FDA: February 18, 2026
Distribution: U.S. Nationwide

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Drug Recall Ongoing 2026 recordClass II

Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-354-01; Blister NDC 68084-354-11

by Amerisource Health Services LLC

Reason: Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Recall initiated: January 14, 2026
Reported by FDA: February 18, 2026
Distribution: Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.

by Fresenius Kabi Compounding, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: February 5, 2026
Reported by FDA: February 18, 2026
Distribution: US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59

by Fresenius Kabi Compounding, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: February 5, 2026
Reported by FDA: February 18, 2026
Distribution: US Nationwide.

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Data last updated: October 30, 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.