Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Telmisartan and Amlodipine Tablets 80 mg/5 mg Recalled by Lupin Pharmaceuticals Inc. Due to Failed Impurities/Degradation Specifications; 18 month long term stability...

Date: April 1, 2019
Company: Lupin Pharmaceuticals Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Lupin Pharmaceuticals Inc. directly.

Affected Products

Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by : Lupin Limited, Goa, INDIA -- NDC 68180-198-06

Quantity: 12,504 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications; 18 month long term stability study.

Where Was This Sold?

Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States.

About Lupin Pharmaceuticals Inc.

Lupin Pharmaceuticals Inc. has 119 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report