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
- Affected units
- 574
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.
Part of a larger recall action
This product is one of 2 recalled by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
See all →- LowButalbital/APAP/Caf Tablets Missing Controlled Substance Label
FDA (Drugs) · 2021-12-01
- SevereMethocarbamol Tablets Mislabeled with Incorrect Strength
FDA (Drugs) · 2021-11-10
- SevereSpironolactone Tablets Recalled Due to Potential Labeling Error
FDA (Drugs) · 2021-03-24
- ModerateSpironolactone Tablets Recalled Due to Potential Labeling Mix-Up
FDA (Drugs) · 2021-03-24
Same hazard · mis labeling
See all →- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White Herbal Supplement Recalled for Undeclared Walnut Allergen
FDA (Food) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- HighHalyard DAVINCI TRUCUSTOM Foley Catheter Kits Recalled for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02