# FDA recall D-0013-2021

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2020-08-24.

## Product

Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

## Reason for recall

CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.

## Distribution

Nationwide in the U.S. and Puerto Rico.

## Key facts

- **Recall number:** D-0013-2021
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-08-24
- **Report date:** 2020-09-16
- **Termination date:** 2021-12-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0013-2021

## Citation

> AI Analytics. FDA recall D-0013-2021. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/D-0013-2021. Source: US FDA. Licensed CC0.

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