FDA Drug recall D-0461-2022
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis…
- FDA Drug
- Class II
- terminated
- Published 2022-02-09
On 2022-02-09 the FDA classified a Class II recall of Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis… by Teva Pharmaceuticals Usa, citing failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0461-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-18 |
| Published | 2022-02-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
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
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Identifiers
| ndc | 0591-2132-01 |
|---|---|
| code_info | Lot# 100025842, 100028023, Exp Date 08/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0461-2022%22
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