The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0256-2022·Announced 2021-12-01

Butalbital/APAP/Caf Tablets Missing Controlled Substance Label

Bryant Ranch Prepack is recalling Butalbital, APAP, and Caffeine 50/325/40 mg tablets because the label is missing the controlled substance classification "CIII" required by law.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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—specifically, the omission of a required controlled substance classification marking. The hazard is documentary/regulatory in nature with no reported safety risk, injury, illness, or product defect. Per the severity rubric, labeling errors and documentation issues fall into the Low severity category.

Plain-English summary

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals is recalling Butalbital, APAP, and Caffeine (Butalbital 50 mg, Acetaminophen 325 mg, Caffeine 40 mg) tablets due to a labeling defect. The controlled substance classification "CIII" is missing from the product label.

The affected products include 12-count bottles (NDC: 63629-8392-09), 60-count bottles (NDC: 63629-8392-03), and 90-count bottles (NDC: 63629-8392-04) distributed nationwide in the USA. A total of 119 bottles have been recalled. Specific lot numbers and expiration dates are documented in the source material.

This is a prescription-only medication. Consumers who have received bottles of this product should contact their pharmacy or healthcare provider. The missing label classification does not indicate the medication itself is unsafe, but rather that the required regulatory labeling is incomplete.

The recalled product

Product
Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, barcode 083924152614, Lannett Company Inc; Rx only, Packaged…
Manufacturer
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Category
Drug — Prescription Analgesic Combination
Hazard
Affected units
119

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 (14)

  • a) Lots: 152838
  • 152156
  • 152151
  • 151708
  • 151693
  • 151375
  • 151131
  • 151114
  • Exp: 7/31/2022
  • b) Lots: 152245
  • 151822
  • 151160
  • c) Lot #: 152614
  • Exp: 7/31/2022.

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 →

Same hazard · mis labeling

See all →

Similar recalls