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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

AvKARE Tranexamic Acid Tablets Recalled for Failed Conductivity Testing

Agency Publication Date: June 15, 2023
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Summary

AvKARE LLC is recalling 592 cartons of Tranexamic Acid USP Tablets (650 mg), a prescription medication used to treat heavy menstrual bleeding. The recall affects 30-tablet unit dose cartons (containing 3 strips of 10 tablets each) that failed quality testing for conductivity, indicating the presence of impurities or product degradation. Consumers who have this medication should consult their pharmacist or healthcare provider and follow instructions for return or disposal.

Risk

The tablets failed conductivity specifications, which suggests the medication may contain impurities or has begun to degrade, potentially compromising the quality and safety of the drug. No injuries or adverse events have been reported to date.

What You Should Do

  1. This recall affects AvKARE Tranexamic Acid USP Tablets (650 mg), sold in 30-tablet unit dose cartons under NDC 50268-772-13.
  2. Check your medication carton and unit dose strips for lot number 44286 with an expiration date of 02/2025.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Tranexamic Acid USP Tabletsby AvKARE
Variants: 650 mg, 30 tablets (3X10) Unit Dose, Rx Only
Lot Numbers:
44286 (Exp 02/2025)
NDC:
50268-772-13

Recall number D-0875-2023; Manufactured for AvKARE Pulaski, TN.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92535
Status: Active
Manufacturer: AVKARE LLC
Manufactured In: United States
Units Affected: 592 cartons
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.