The Recall Desk
LowFDA (Drugs)·D-0257-2022·Announced 2021-12-01

Butalbital, APAP, Caffeine Tablets Missing Schedule III Label

Bryant Ranch Prepack is recalling Butalbital, APAP, Caffeine 50/325/40 mg tablets in multiple bottle sizes because the controlled substance classification "CIII" is missing from the label.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is an FDA Class III recall involving a labeling defect—the missing controlled substance classification marking. The hazard is documentary/regulatory, not patient safety–based. No illnesses, injuries, or therapeutic harm are reported or implied in the source text.

Plain-English summary

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals is recalling Butalbital, APAP, Caffeine 50/325/40 mg Tablets nationwide in the USA. The tablets are packaged in 12-count, 20-count, 30-count, 60-count, 90-count, and 120-count bottles under the brand Westminster Pharmaceuticals LLC, Rx only. A total of 574 bottles have been distributed.

The product is being recalled because the controlled substance classification "CIII" (Schedule III) is missing from the label. Butalbital is a Schedule III controlled substance, and this required designation must appear on the product label.

Affected lot numbers and expiration dates span from July 2022 through February 2023. Consumers who have purchased this medication should contact their pharmacy or healthcare provider. Healthcare providers and pharmacies should stop dispensing affected lots immediately.

The recalled product

Product
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
Manufacturer
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Category
Drug — Labeling / Controlled Substance
Hazard
  • mis-labeling
  • missing-controlled-substance-marking

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • a) Lots: 164865
  • Exp: 2/28/2021
  • 162113
  • Exp: 8/31/2022
  • 160419
  • Exp: 2/28/2023
  • 160004
  • 155752
  • 154380
  • 153776
  • 152889
  • b) Lots: 157837
  • 154997
  • c) Lots: 165687
  • 160330
  • 159973
  • 159943
  • 159352
  • 159345
  • 158841

Distribution

Distributed nationwide across the United States.

Related recalls

Same category