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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

Micro Labs Telmisartan Tablets Recalled for Failed Stability Tests

Agency Publication Date: March 14, 2024
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Summary

Micro Labs Limited is recalling 118,080 bottles of Telmisartan Tablets (40mg), a prescription medication used to treat high blood pressure. The recall was issued because the tablets failed stability testing for blend uniformity, meaning the active ingredients may not be evenly distributed throughout each tablet. If you are taking this medication, you should contact your healthcare provider or pharmacist to discuss your treatment before you stop taking the tablets.

Risk

The failure in blend uniformity means that some tablets may contain too much or too little of the active medication. This could lead to inconsistent blood pressure control or an increased risk of side effects.

What You Should Do

  1. This recall affects 30-count bottles of Telmisartan Tablets, USP 40mg, sold under the Micro Labs brand (NDC 42571-227-30). Affected bottles include lot numbers SFBG024 and SFBG025 with an expiration date of 05/31/2024.
  2. If you have health concerns, contact your healthcare provider or pharmacist for guidance.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact Micro Labs Limited 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: Telmisartan Tablets, USP 40mg (30 Tablets per bottle)by Micro Labs
Variants: 40mg, Tablet
Lot Numbers:
SFBG024 (Exp. 05/31/2024)
SFBG025 (Exp. 05/31/2024)
NDC:
42571-227-30

Quantity: 118,080 bottles

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93965
Status: Resolved
Manufacturer: Micro Labs Limited
Sold By: Pharmacies
Manufactured In: India
Units Affected: 118,080 bottles
Distributed To: Puerto Rico, Tennessee, Rhode Island

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.