# FDA recall D-1703-2012

> **Mylan Pharmaceuticals Inc.** · Class III · drug recall initiated 2012-06-28.

## Product

Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01

## Reason for recall

Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.

## Distribution

Nationwide and PR

## Key facts

- **Recall number:** D-1703-2012
- **Recalling firm:** Mylan Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-06-28
- **Report date:** 2012-10-10
- **Termination date:** 2013-03-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morgantown, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1703-2012

## Citation

> AI Analytics. FDA recall D-1703-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1703-2012. Source: US FDA. Licensed CC0.

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