US Drug Recall Register
Class III · Low risk Ongoing Initiated Sep 28, 2021 (5 years ago)

Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label

What was recalled

Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20-count bottles, NDC: 71335-1767-01, barcode 083921157837; c) 30-count bottles, NDC: 71335-1767-02, barcode 083922165687, d) 60-count bottles, NDC: 71335-1767-03, barcode 083923153776, e) 90-count bottles, NDC: 71335-1767-04, barcode 083924152889, f) 120-count bottles, NDC: 71335-1767-07, barcode 083927153735. Westminster Pharmaceuticals LLC, Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504 USA

Recalling firm
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0257-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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