Famotidine Tablets USP 40mg — Class II drug recall D-0290-2021
Terminated recall by Aurobindo Pharma USA Inc., reported 2021-03-10, distributed in CA, GA, PA, TX. Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famot
| Recall number | D-0290-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc., East Windsor, NJ, United States |
| Recall initiated | 2021-01-20 |
| Classified | 2021-02-26 |
| Reported by FDA | 2021-03-10 |
| Terminated | 2023-10-12 |
| Distributed | CA, GA, PA, TX |
| Quantity | 1,296 bottles |
| NDC | 65862-0859, 65862-0859-01, 65862-0859-05, 65862-0859-10, 65862-0859-30, 65862-0859-78, 65862-0859-99, 65862-0860, 65862-0860-01, 65862-0860-05, 65862-0860-10, 65862-0860-30, 65862-0860-78, 65862-0860-99 |
| Lot numbers | P2000467 |
| Expiration dates | 2022-07 |
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 for recall
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0290-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.