SECONAL SODIUM — Class III drug recall D-1059-2016
Terminated recall by Valeant Pharmaceuticals North America LLC, reported 2016-07-06, distributed nationwide. Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
| Recall number | D-1059-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, United States |
| Recall initiated | 2016-06-10 |
| Classified | 2016-06-30 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2017-06-14 |
| Distributed | Nationwide (US) |
| Quantity | 958 bottles |
| Reason classes | labeling |
| NDC | 00187-4220-10 |
| Lot numbers | 2555979 |
| Expiration dates | 2016-09 |
Product
SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ 08807. NDC: 0187-4220-10.
Reason for recall
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
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-1059-2016. 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.