# FDA recall D-0009-2018

> **Dr. Reddy's Laboratories, Inc.** · Class III · drug recall initiated 2017-10-03.

## Product

Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, b) Equate Famotidine, NDC 49035-118-30, Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, Made in India

## Reason for recall

Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0009-2018
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-10-03
- **Report date:** 2017-10-18
- **Termination date:** 2019-03-15

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0009-2018

## Citation

> AI Analytics. FDA recall D-0009-2018. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/D-0009-2018. Source: US FDA. Licensed CC0.

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