Lower risk Drug recall · FDA · Published September 28, 2021

BRP Pharmaceuticals Butalbital Tablets Recall: Missing CIII Label

BRP Pharmaceuticals recalls 12-count and other Butalbital tablets due to missing controlled substance classification CIII label on packaging. Consumers should check product details and contact the company for guidance.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0257-2022Drug BRP Pharmaceuticals ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmBryant Ranch Prepack, Inc. dba BRP Pharmaceuticals1919 N Victory Pl · Burbank, CA 91504-3425

✎ GovInfoNow plain-language explainer

BRP Pharmaceuticals is recalling certain Butalbital tablets because the label does not show the correct controlled substance classification (CIII). This means the product might be misclassified, but there is no immediate risk of injury or harm from the product itself. Read more at govinfonow.com/recall/35834-brp-pharmaceuticals-butalbital-tablets-recall-missing-ciii-label.

Source Summary by GovInfoNow · govinfonow.com/recall/35834-brp-pharmaceuticals-butalbital-tablets-recall-missing-ciii-label · Updated August 18, 2026 · FDA enforcement record: FDA #D-0257-2022

Cite this page

“BRP Pharmaceuticals Butalbital Tablets Recall: Missing CIII Label.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35834-brp-pharmaceuticals-butalbital-tablets-recall-missing-ciii-label. Based on FDA recall #D-0257-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0257-2022%22&limit=1).

The FDA announced on Sept. 28, 2021, that Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals is recalling Butalbital, APAP, Caf 50/325/40 Tablets because the label omits the required controlled substance classification "CIII." The agency issued recall number D-0257-2022 for the voluntary Class III action.

How to tell if you have it

Brand: BRP Pharmaceuticals
Product: Butalbital, APAP, Caf 50/325/40 Tablet
Packaging: 12-count bottles (NDC: 71335-1767-09, barcode 083929164865), 20-count bottles (NDC: 71335-1767-01, barcode 083921157837), 30-count bottles (NDC: 71335-1767-02, barcode 083922165687), 60-count bottles (NDC: 71335-1767-03, barcode 083923153776), 90-count bottles (NDC: 71335-1767-04, barcode 083924152889), 120-count bottles (NDC: 71335-1767-07, barcode 083927153735)
Lots: 164865, 162113, 160419, 160004, 155752, 154380, 153776, 152889, 152347, 152245, 152156, 152197, 151338, 151160, 157837, 154997, 165687, 160330, 159973, 159943, 159352, 159345, 158841, 162641, 153735
Distribution: Nationwide in the USA

The hazard

The recall is due to labeling errors where the controlled substance classification "CIII" is missing from the label. The FDA classified this as a Class III recall, indicating it is not likely to cause adverse health reactions.

Context

GovInfoNow's records show Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals has two other recalls on record since Jan. 27, 2021. On Oct. 12, 2021, the company recalled Methocarbamol 500mg Tablets due to a strength label error, and on Jan. 27, 2021, it recalled Spironolactone Tablets 25mg due to a label mix-up risk. Other recent recalls of similar products include American Regent Levocarnitine Injection Recall: Missing Label Hazard (April 16, 2026), American Health Packaging Buprenorphine Tablets Recall: Label Mix-Up Hazard (Aug. 19, 2026), and Bionpharma Divalproex Tablets Recall: Foreign Tablets Risk (June 26, 2026).

How to tell if you have this one

Check for the product names 'Butalbital, APAP, Caf 50/325/40 Tablet' in 12-count, 20-count, 30-count, 60-count, 90-count, or 120-count bottles. Look for the NDC codes listed in the recall notice or the barcodes provided.

Brand
BRP Pharmaceuticals
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class III
Status
Ongoing
Distribution
Nationwide in the USA

Recall number	Product, codes & lots	Quantity
D-0256-2022	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 by Bryant Ranch Prepack, Burbank, CA 91504.; a) Lots: 152838, 152156, 152151, 151708, 151693, 151375, 151131, 151114, Exp: 7/31/2022, b) Lots: 152245, 151822, 151708, 151160, 151131, Exp: 7/31/2022, c) Lot #: 152614, Exp: 7/31/2022.	119 Bottles
D-0257-2022	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; a) Lots: 164865, Exp: 2/28/2021; 162113, Exp: 8/31/2022; 160419, Exp: 2/28/2023; 160004, 155752, 154380, 153776, 152889, Exp: 8/31/2022, b) Lots: 157837, 154997, Exp: 8/31/2022, c) Lots: 165687, 160419, 160330, Exp: 2/28/2023; 159973, 159943, 159352, 159345, 158841, 155752, 152347, Exp: 8/31/2022; 152245, 152156, 152197, 151338, 151160, Exp: 7/31/2022, d) Lots: 162641, Exp: 2/28/2023; 154380, 153776, 152889, Exp: 8/31/2022, e)Lots: 158841, 152889, Exp: 8/31/2022, f) Lots: 153776, 153735, 152347, Exp: 8/31/2022	574 Bottles

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the product by checking the NDC codes (71335-1767-09 to 71335-1767-07) or barcodes on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

Sep 28, 2021Firm started the recall
Nov 23, 2021FDA classified it Class III
Dec 1, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of injury from this product?

No, the recall is for labeling compliance, not an immediate safety hazard.

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Link to this recall

<a href="https://govinfonow.com/recall/35834-brp-pharmaceuticals-butalbital-tablets-recall-missing-ciii-label">BRP Pharmaceuticals Butalbital Tablets Recall: Missing CIII Label (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0257-2022 (September 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0257-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.