# FDA recall D-0290-2021

> **Aurobindo Pharma USA Inc.** · Class II · drug recall initiated 2021-01-20.

## 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.

## Distribution

TX, CA, GA, PA

## Key facts

- **Recall number:** D-0290-2021
- **Recalling firm:** Aurobindo Pharma USA Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-01-20
- **Report date:** 2021-03-10
- **Termination date:** 2023-10-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Windsor, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0290-2021

## Citation

> AI Analytics. FDA recall D-0290-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0290-2021. Source: US FDA. Licensed CC0.

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