Famotidine Tablet, Film Coated
FDA Recall NDC 65862-860
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Famotidine (NDC 65862-860). A significant event, classified as Class II, was initiated on Jan 20, 2021 by Aurobindo Pharma Limited. The reported reason for this action was: "Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Jan 20, 2021
Mar 10, 2021
1296 bottles
Recall Profile & Regulatory Data
Event ID
87193
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
TX, CA, GA, PA
Termination Date
Oct 12, 2023
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
Batch or Lot Expiration Information
Lot# : P2000467, Exp 7/2022
Affected Packages Involved in this Recall
65862-859-30Product
65862-859-01Product
65862-859-05Product
65862-859-99Product
65862-859-10Product
65862-859-78Product
65862-860-30Product
65862-860-01Product
65862-860-05Product
65862-860-99Product
65862-860-10Product
65862-860-78Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
