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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Bryant Ranch Butalbital, Acetaminophen, and Caffeine Tablets Missing Label

Agency Publication Date: November 23, 2021
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Summary

Bryant Ranch Prepack, Inc. is recalling 693 bottles of Butalbital, Acetaminophen, and Caffeine Tablets (50/325/40 mg) because the bottle labels are missing the "CIII" classification. This designation is required to identify the medication as a Schedule III controlled substance. The recall affects various bottle sizes ranging from 12 to 120 tablets sold under the Lannett Company Inc and Westminster Pharmaceuticals LLC labels. No incidents or injuries have been reported to date.

Risk

The missing label fails to inform patients and healthcare providers that the medication is a controlled substance, which carries specific risks for abuse and dependency. It also prevents proper legal documentation and handling of the drug.

What You Should Do

  1. The recalled products are Butalbital, APAP, Caf 50/325/40 mg tablets packaged in various sizes including 12, 20, 30, 60, 90, and 120-count bottles. These were distributed nationwide under the brands Lannett Company Inc and Westminster Pharmaceuticals LLC.
  2. Identify your medication by checking the National Drug Code (NDC) and lot numbers printed on the bottle label. Affected NDC numbers include 63629-8392-09, 63629-8392-03, 63629-8392-04, 71335-1767-09, 71335-1767-01, 71335-1767-02, 71335-1767-03, 71335-1767-04, and 71335-1767-07. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Bryant Ranch Prepack, Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Butalbital, APAP, Caf 50/325/40 Tablets (Lannett Company Inc)
Variants: 50 mg Butalbital / 325 mg Acetaminophen / 40 mg Caffeine, 12-count bottle, 60-count bottle, 90-count bottle
UPC Codes:
083929152151
083923152614
083924152614
Lot Numbers:
152838 (Exp: 7/31/2022)
152156 (Exp: 7/31/2022)
152151 (Exp: 7/31/2022)
151708 (Exp: 7/31/2022)
151693 (Exp: 7/31/2022)
151375 (Exp: 7/31/2022)
151131 (Exp: 7/31/2022)
151114 (Exp: 7/31/2022)
152245 (Exp: 7/31/2022)
151822 (Exp: 7/31/2022)
151160 (Exp: 7/31/2022)
152614 (Exp: 7/31/2022)
NDC:
63629-8392-09
63629-8392-03
63629-8392-04

Packaged by Bryant Ranch Prepack, Burbank, CA. Prescription only.

Product: Butalbital, APAP, Caf 50/325/40 Tablets (Westminster Pharmaceuticals LLC)
Variants: 50 mg Butalbital / 325 mg Acetaminophen / 40 mg Caffeine, 12-count bottle, 20-count bottle, 30-count bottle, 60-count bottle, 90-count bottle, 120-count bottle
UPC Codes:
083929164865
083921157837
083922165687
083923153776
083924152889
083927153735
Lot Numbers:
164865 (Exp: 2/28/2021)
162113 (Exp: 8/31/2022)
160419 (Exp: 2/28/2023)
160004 (Exp: 8/31/2022)
155752 (Exp: 8/31/2022)
154380 (Exp: 8/31/2022)
153776 (Exp: 8/31/2022)
152889 (Exp: 8/31/2022)
157837 (Exp: 8/31/2022)
154997 (Exp: 8/31/2022)
165687 (Exp: 2/28/2023)
160330 (Exp: 2/28/2023)
159973 (Exp: 8/31/2022)
159943 (Exp: 8/31/2022)
159352 (Exp: 8/31/2022)
159345 (Exp: 8/31/2022)
158841 (Exp: 8/31/2022)
152347 (Exp: 8/31/2022)
152245 (Exp: 7/31/2022)
152156 (Exp: 7/31/2022)
152197 (Exp: 7/31/2022)
151338 (Exp: 7/31/2022)
151160 (Exp: 7/31/2022)
162641 (Exp: 2/28/2023)
153735 (Exp: 8/31/2022)
NDC:
71335-1767-09
71335-1767-01
71335-1767-02
71335-1767-03
71335-1767-04
71335-1767-07

Packaged by Bryant Ranch Prepack, Burbank, CA. Prescription only.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88847
Status: Active
Manufacturer: Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Sold By: Pharmacy; Lannett Company Inc; Westminster Pharmaceuticals LLC
Manufactured In: United States
Units Affected: 2 products (119 Bottles; 574 Bottles)
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.