# FDA recall D-0440-2017

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2016-12-21.

## Product

Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73

## Reason for recall

Subpotency: due to a low, out of specification test result for assay during stability testing.

## Distribution

United States and Puerto Rico

## Key facts

- **Recall number:** D-0440-2017
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-12-21
- **Report date:** 2017-02-01
- **Termination date:** 2018-02-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0440-2017

## Citation

> AI Analytics. FDA recall D-0440-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0440-2017. Source: US FDA. Licensed CC0.

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