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Class II · ModerateRecall completed

Famotidine

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: P2000467, Exp 7/2022
Where it was soldTX, CA, GA, PA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameFAMOTIDINE
Generic nameFAMOTIDINE
Active ingredient(s)FAMOTIDINE
Distributed by / forAurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520
NDC65862-860-99
Show the full FDA record
Full product labelFamotidine 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
Recalling firmAurobindo Pharma USA Inc.
DistributionTX, CA, GA, PA
Quantity1296 bottles
Recall initiated2021-01-20
Report date2021-03-10
Recall completed2023-10-12
Recall numberD-0290-2021
ClassificationClass II
FDA statusTerminated
Origin on fileEast Windsor NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.