RecallRadar

FDA Drug recall D-0290-2021

Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Wi…

On 2021-03-10 the FDA classified a Class II recall of Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Wi… by Aurobindo Pharma Usa, citing presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0290-2021
ClassificationClass II
Statusterminated
Initiated2021-01-20
Published2021-03-10
Last updated2026-09-13 11:52 UTC
CompanyAurobindo Pharma Usa
DistributionCA, GA, PA, TX

Product

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

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

Identifiers

ndc65862-859-30
ndc65862-859-01
ndc65862-859-05
ndc65862-859-99
ndc65862-859-10
ndc65862-859-78
ndc65862-860-30
ndc65862-860-01
ndc65862-860-05
ndc65862-860-99
ndc65862-860-10
ndc65862-860-78
code_infoLot #: P2000467, Exp 7/2022

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0290-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.