# FDA recall D-0851-2020

> **Teva Pharmaceuticals USA** · Class III · drug recall initiated 2020-01-28.

## Product

Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles  (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545

## Reason for recall

Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-0851-2020
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-01-28
- **Report date:** 2020-02-26
- **Termination date:** 2021-05-19

- **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-0851-2020

## Citation

> AI Analytics. FDA recall D-0851-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0851-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*