# FDA recall D-1058-2016

> **Dr. Reddy's Laboratories, Inc.** · Class III · drug recall initiated 2016-04-22.

## Product

CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC,  Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523

## Reason for recall

Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1058-2016
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-04-22
- **Report date:** 2016-07-06
- **Termination date:** 2017-04-26

- **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-1058-2016

## Citation

> AI Analytics. FDA recall D-1058-2016. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-1058-2016. Source: US FDA. Licensed CC0.

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