RecallRadar

FDA Drug recall D-1059-2016

SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only

On 2016-07-06 the FDA classified a Class III recall of SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only by Valeant Pharmaceuticals North America, citing labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1059-2016
ClassificationClass III
Statusterminated
Initiated2016-06-10
Published2016-07-06
Last updated2026-09-13 11:51 UTC
CompanyValeant Pharmaceuticals North America
DistributionUS

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

Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.

Identifiers

code_infoLot #: 2555979, Expiry: 09/2016.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1059-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.