Medications & Supplements/Prescription Drugs

Alembic Pharmaceuticals Limited: Telmisartan Tablets Recalled Due to Label Mix-up

Agency Publication Date: April 7, 2021

Summary

Alembic Pharmaceuticals Limited is voluntarily recalling 12,288 bottles of Telmisartan Tablets, USP (20 mg), a prescription medication used to treat high blood pressure. The recall was initiated because of a label mix-up, which could result in patients receiving the wrong medication or incorrect dosage information. These 30-count bottles were distributed nationwide across the United States.

Risk

A label mix-up can lead to a patient taking the incorrect medication or an incorrect dose, which may fail to treat their underlying condition or cause unexpected side effects. There have been no reports of injuries or adverse events associated with this recall to date.

What You Should Do

Check your prescription bottle to see if you have Telmisartan Tablets, USP 20 mg, in 30-count bottles with the NDC number 62332-087-30.
Verify the bottle for Lot number 1905005661 and an expiration date of March 2022.
If your medication matches this lot number and expiration date, contact your healthcare provider or pharmacist immediately for guidance before you stop taking the medication.
Return any unused or affected product to your pharmacy to receive a refund.
Contact Alembic Pharmaceuticals Limited for further instructions regarding this recall.
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

Full Refund

Healthcare provider consultation and pharmacy refund.

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

Affected Products

Product: Telmisartan Tablets, USP 20 mg (30-count bottle)

Model:

NDC 62332-087-30

Recall #: D-0326-2021

Lot Numbers:

1905005661 (Exp March 2022)

Date Ranges: Expiration March 2022

Product Images

Telmisartan Tablets, USP, 20 mg, 30 tablets, Rx only, label

Telmisartan Tablets, USP, 20 mg pill image

Telmisartan Tablets, USP, 40 mg pill image

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87533

Status: Resolved

Manufacturer: Alembic Pharmaceuticals Limited

Sold By: Pharmacies

Manufactured In: India

Units Affected: 12288 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 · FDA Press Release · 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.

Summary

What You Should Do

Check your prescription bottle to see if you have Telmisartan Tablets, USP 20 mg, in 30-count bottles with the NDC number 62332-087-30.

Verify the bottle for Lot number 1905005661 and an expiration date of March 2022.

If your medication matches this lot number and expiration date, contact your healthcare provider or pharmacist immediately for guidance before you stop taking the medication.

Return any unused or affected product to your pharmacy to receive a refund.

Contact Alembic Pharmaceuticals Limited for further instructions regarding this recall.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.