# FDA recall D-0809-2016

> **Bio-pharm, Inc.** · Class III · drug recall initiated 2015-12-17.

## Product

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51

## Reason for recall

Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0809-2016
- **Recalling firm:** Bio-pharm, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-12-17
- **Report date:** 2016-04-13
- **Termination date:** 2017-05-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Levittown, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0809-2016

## Citation

> AI Analytics. FDA recall D-0809-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0809-2016. Source: US FDA. Licensed CC0.

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