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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Prasugrel Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: March 20, 2025
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Summary

Golden State Medical Supply Inc. is recalling 2,601 30-count bottles of Prasugrel (generic Effient) 5 mg tablets because they failed dissolution testing. This means the tablets may not dissolve properly in the body as intended. Consumers who have been prescribed this medication should consult their doctor or pharmacist regarding the recall and their continuing treatment.

Risk

If the medication fails to dissolve correctly, the patient may not receive the full therapeutic dose. For a blood thinner like Prasugrel, this could increase the risk of blood clots, heart attacks, or strokes in patients being treated for cardiovascular conditions.

What You Should Do

  1. This recall affects 30-count bottles of Prasugrel Tablets (5 mg) with NDC 51407-444-30, packaged by GSMS, Incorporated.
  2. Check the lot number and expiration date printed on the bottle label. See the Affected Products section below for the full list of affected codes.
  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 more information 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: Prasugrel Tablets (5 mg)
Variants: 5 mg, 30-count bottle, Tablet
Lot Numbers:
GS059908 (Exp 04/30/2026)
GS060228 (Exp 04/30/2026)
GS060709 (Exp 04/30/2026)
GS061233 (Exp 04/30/2026)
GS061704 (Exp 04/30/2026)
GS062158 (Exp 04/30/2026)
GS062405 (Exp 04/30/2026)
NDC:
51407-444-30

Rx only; packaged by GSMS, Incorporated.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96441
Status: Active
Manufacturer: Golden State Medical Supply Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 2,601 30-count bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.