Phenobarbital Tablets USP — Class I drug recall D-1111-2017
Terminated recall by C. O. Truxton, reported 2017-08-30, distributed nationwide. Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablet
| Recall number | D-1111-2017 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C. O. Truxton, Bellmawr, NJ, United States |
| Recall initiated | 2017-04-20 |
| Classified | 2017-08-22 |
| Reported by FDA | 2017-08-30 |
| Terminated | 2018-09-11 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, potency |
| NDC | 00463-6160-10 |
| Lot numbers | 11/17, 70952A |
Product
Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10
Reason for recall
Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
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-1111-2017. 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.