Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release… — Class II drug recall D-0461-2022
Terminated recall by Teva Pharmaceuticals USA, reported 2022-02-09, distributed nationwide. Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
| Recall number | D-0461-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2022-01-18 |
| Classified | 2022-01-28 |
| Reported by FDA | 2022-02-09 |
| Terminated | 2022-12-21 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00591-2132, 00591-2132-01 |
| Lot numbers | 100025842, 100028023 |
| Expiration dates | 2023-08 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0461-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.