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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

Torrent Telmisartan and Hydrochlorothiazide Recalled for Superpotency

Agency Publication Date: December 16, 2021
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Summary

Torrent Pharma Inc. is recalling 27,312 bottles of Telmisartan and Hydrochlorothiazide (40 mg/12.5 mg) tablets, a prescription medication used to treat high blood pressure. The recall was initiated because the product may be superpotent, meaning it contains higher levels of the active ingredient hydrochlorothiazide than specified. No injuries or incidents related to this issue have been reported to date.

Risk

Taking superpotent blood pressure medication can cause an excessive drop in blood pressure or electrolyte imbalances. This poses a health risk, particularly to patients who may be more sensitive to changes in their blood pressure levels.

What You Should Do

  1. The recalled product is Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg sold in 30-count bottles with NDC 13668-159-30 and batch number BZ74G001 (expiration 12/2021).
  2. If you have health concerns, contact your healthcare provider or pharmacist.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact Torrent Pharma Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

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 and Hydrochlorothiazide Tablets, USP (30 count bottles)
Variants: 40 mg/12.5 mg, Rx only
Lot Numbers:
BZ74G001 (Exp. 12/2021)
NDC:
13668-159-30

Manufactured by Torrent Pharmaceuticals LTD, India for Torrent Pharma Inc., Basking Ridge, NJ. Total quantity: 27,312 Bottles.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89141
Status: Resolved
Manufacturer: Torrent Pharma Inc.
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 27,312 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.