Class III โ€” Low Risk

Low risk โ€” 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 AVKARE Inc. Due to Failed Impurities/Degradation Specifications; 18 month long term stability...

Date: April 3, 2019
Company: AVKARE 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 AVKARE Inc. directly.

Affected Products

Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30

Quantity: 397 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)

Where Was This Sold?

This product was distributed to 2 states: AZ, CO

Affected (2 states)Not affected

About AVKARE Inc.

AVKARE Inc. has 33 total recalls tracked by RecallDetector.

Related Recalls

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