# FDA recall D-0529-2020

> **AuroMedics Pharma LLC** · Class II · drug recall initiated 2019-11-06.

## Product

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India  NDC 65862-431-74

## Reason for recall

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

## Distribution

nationwide

## Key facts

- **Recall number:** D-0529-2020
- **Recalling firm:** AuroMedics Pharma LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2019-11-06
- **Report date:** 2019-12-04

- **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-0529-2020

## Citation

> AI Analytics. FDA recall D-0529-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0529-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*