Class III โ€” Low Risk

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

Amlodipine and Olmesartan Medoxomil Tablets Recalled by Aurobindo Pharma USA Inc. Due to Discoloration: This product is being recalled due to...

Date: November 30, 2018
Company: Aurobindo Pharma USA 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 Aurobindo Pharma USA Inc. directly.

Affected Products

Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30

Quantity: 4464 bottles

Why Was This Recalled?

Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Aurobindo Pharma USA Inc.

Aurobindo Pharma USA Inc. has 47 total recalls tracked by RecallDetector.

Related Recalls

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