# FDA recall D-803-2013

> **Teva Pharmaceuticals USA, Inc.** · Class III · drug recall initiated 2013-06-18.

## Product

Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only,  Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960.

## Reason for recall

Discoloration:  This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-803-2013
- **Recalling firm:** Teva Pharmaceuticals USA, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-06-18
- **Report date:** 2013-07-24
- **Termination date:** 2013-12-24

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-803-2013

## Citation

> AI Analytics. FDA recall D-803-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-803-2013. Source: US FDA. Licensed CC0.

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