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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

BAYSHORE PHARMACEUTICALS: Metformin Hydrochloride Extended-Release Tablets Recalled for CGMP Deviations

Agency Publication Date: August 25, 2020
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Summary

Bayshore Pharmaceuticals has recalled 4,578 bottles of Metformin Hydrochloride Extended-Release Tablets (USP), a prescription medication used to manage blood sugar in patients with type 2 diabetes. The recall includes 594 bottles of 500 mg tablets and 3,984 bottles of 750 mg tablets due to deviations from Current Good Manufacturing Practice (CGMP) requirements. Because these medications did not meet specific manufacturing standards, consumers should consult their healthcare provider or pharmacist for guidance on how to safely transition to an alternative treatment before stopping the medication.

Risk

The recall was initiated due to manufacturing deviations (CGMP), which means the products may not meet the quality and safety standards required by the FDA. Stopping a diabetes medication without a replacement can pose immediate health risks, so patients must coordinate with a healthcare professional before returning the product.

What You Should Do

  1. Check your medication bottle for Metformin Hydrochloride Extended-Release Tablets USP, 500 mg (1000 count bottle) with NDC 76385-128-10, Lot #18641, and an expiration date of 05/2021.
  2. Check your medication bottle for Metformin Hydrochloride Extended-Release Tablets USP, 750 mg (100 count bottle) with NDC 76385-129-01, Lot #18657, and an expiration date of 05/2021.
  3. If you have an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on your treatment and to obtain a replacement prescription.
  4. Return any unused portions of the recalled medication to the pharmacy where it was purchased for a refund.
  5. Contact Bayshore Pharmaceuticals or the manufacturer for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Consult healthcare provider and return to pharmacy.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Metformin Hydrochloride Extended-Release Tablets USP, 500 mg (1000 Tablets)
Model:
NDC 76385-128-10
Recall #: D-1543-2020
Lot Numbers:
18641 (Exp. 05/2021)
Date Ranges: Expiration 05/2021
Product: Metformin Hydrochloride Extended-Release Tablets USP, 750 mg (100 Tablets)
Model:
NDC 76385-129-01
Recall #: D-1544-2020
Lot Numbers:
18657 (Exp. 05/2021)
Date Ranges: Expiration 05/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86280
Status: Resolved
Manufacturer: BAYSHORE PHARMACEUTICALS
Sold By: Pharmacies nationwide
Manufactured In: Bangladesh, United States
Units Affected: 2 products (594 bottles; 3984 bottles)
Distributed To: Nationwide
Agency Last Updated: September 8, 2020

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.