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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

Lysteda (tranexamic acid) Recalled for Impurity and Conductivity Issues

Agency Publication Date: June 14, 2023
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Summary

Amring Pharmaceuticals Inc has voluntarily recalled 48,989 bottles of Lysteda (tranexamic acid) USP Tablets, 650 mg. The recall was issued because laboratory tests showed the medication failed to meet quality specifications for impurities and conductivity. No injuries or incidents have been reported in connection with this issue, and the product was distributed nationwide to pharmacies and healthcare providers.

Risk

The tablets may contain impurities or degradation products that do not meet standard quality requirements. While the risk to patients is considered low, these issues can compromise the long-term quality and safety of the medication.

What You Should Do

  1. The recalled products are 30-count bottles of Lysteda (tranexamic acid) USP Tablets, 650 mg, used to treat heavy menstrual bleeding.
  2. Identify the affected medication by looking for NDC 69918-301-30 and lot numbers X220317A or X220318A, both with an expiration date of 09/25.
  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 Amring Pharmaceuticals Inc for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

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: Lysteda (tranexamic acid) USP Tablets (30 tablets per bottle)
Variants: 650 mg, Tablet
Lot Numbers:
X220317A (Exp 09/25)
X220318A (Exp 09/25)
NDC:
69918-301-30

Recall Number: D-0871-2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92458
Status: Resolved
Manufacturer: Amring Pharmaceuticals Inc
Sold By: pharmacies; healthcare providers
Manufactured In: United States
Units Affected: 48,989 bottles
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.