# FDA recall D-1205-2019

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2019-04-12.

## Product

Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454.

## Reason for recall

Subpotent Product: assay results for Amoxicillin were below the specification limits.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-1205-2019
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-04-12
- **Report date:** 2019-04-24
- **Termination date:** 2020-07-08

- **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-1205-2019

## Citation

> AI Analytics. FDA recall D-1205-2019. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/D-1205-2019. Source: US FDA. Licensed CC0.

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