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.
View recall →
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
View recall →
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
View recall →
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
View recall →
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
View recall →
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.
View recall →
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.
View recall →
Drug Recall
Ongoing
2026 recordClass II
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.
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.
View recall →
Drug Recall
Ongoing
2026 recordClass II
ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56
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.
View recall →
Drug Recall
Ongoing
2026 recordClass II
acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56
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.
View recall →
Drug Recall
Ongoing
2026 recordClass II
Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32
by F.H. INVESTMENTS, Inc. (dba Asteria Health)
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Recall initiated
- January 26, 2026
- Reported by FDA
- February 18, 2026
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Ongoing
2026 recordClass II
Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32.
by F.H. INVESTMENTS, Inc. (dba Asteria Health)
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Recall initiated
- January 26, 2026
- Reported by FDA
- February 18, 2026
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Ongoing
2026 recordClass II
Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.
by F.H. INVESTMENTS, Inc. (dba Asteria Health)
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Recall initiated
- January 26, 2026
- Reported by FDA
- February 18, 2026
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Ongoing
2026 recordClass II
Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32.
by F.H. INVESTMENTS, Inc. (dba Asteria Health)
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Recall initiated
- January 26, 2026
- Reported by FDA
- February 18, 2026
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Ongoing
2026 recordClass II
Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.
by F.H. INVESTMENTS, Inc. (dba Asteria Health)
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Recall initiated
- January 26, 2026
- Reported by FDA
- February 18, 2026
- Distribution
- Nationwide in the USA
View recall →
Drug Recall
Ongoing
2026 recordClass II
Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01.
by F.H. INVESTMENTS, Inc. (dba Asteria Health)
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Recall initiated
- January 26, 2026
- Reported by FDA
- February 18, 2026
- Distribution
- Nationwide in the USA
View recall →
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.
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