Phenobarbital Tablets — Class II drug recall D-1045-2017
Terminated recall by West-Ward Pharmaceuticals Corp., reported 2016-11-30, distributed nationwide. Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 1
| Recall number | D-1045-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | West-Ward Pharmaceuticals Corp., Eatontown, NJ, United States |
| Recall initiated | 2016-10-03 |
| Classified | 2016-11-18 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2017-12-26 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00143-1455, 00143-1455-01, 00143-1455-05, 00143-1458, 00143-1458-01, 00143-1458-05, 00143-1495, 00143-1495-01, 00143-1495-05, 00143-1500, 00143-1500-01, 00143-1500-05 |
| Lot numbers | 71294A |
| Expiration dates | 2017-05 |
Product
Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01
Reason for recall
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
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-1045-2017. 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.