PlainRecalls
FDA Drug Moderate Class II Terminated

Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India, NDC 65862-860-99

Reported: March 10, 2021 Initiated: January 20, 2021 #D-0290-2021

Product Description

Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India, NDC 65862-860-99

Reason for Recall

Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.

Details

Recalling Firm
Aurobindo Pharma USA Inc.
Units Affected
1296 bottles
Distribution
TX, CA, GA, PA
Location
East Windsor, NJ

Frequently Asked Questions

What product was recalled?
Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India, NDC 65862-860-99. Recalled by Aurobindo Pharma USA Inc.. Units affected: 1296 bottles.
Why was this product recalled?
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 10, 2021. Severity: Moderate. Recall number: D-0290-2021.