# FDA recall D-239-2013

> **Dr Reddys Laboratories Tennessee LLC** · Class II · drug recall initiated 2013-02-15.

## Product

Amoxicillin for Oral Suspension, 125mg/5mL,  a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC 43598-222-52); c)150 mL (NDC 43598-222-53) bottles, Rx only, Dist. By:  Dr. REDDY'S Laboratories, Inc., Bridgewater, NJ  08807

## Reason for recall

Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-239-2013
- **Recalling firm:** Dr Reddys Laboratories Tennessee LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-02-15
- **Report date:** 2013-04-10
- **Termination date:** 2013-10-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bristol, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-239-2013

## Citation

> AI Analytics. FDA recall D-239-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-239-2013. Source: US FDA. Licensed CC0.

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