# FDA recall D-0461-2022

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2022-01-18.

## Product

Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 007045 USA, NDC 0591-2132-01

## Reason for recall

Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0461-2022
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-01-18
- **Report date:** 2022-02-09
- **Termination date:** 2022-12-21

- **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-0461-2022

## Citation

> AI Analytics. FDA recall D-0461-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0461-2022. Source: US FDA. Licensed CC0.

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