Food, drugs, devices › Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Drug recall: Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 6
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals (Burbank, CA) initiated this drug recall on 28 Sep 2021; FDA lists 2 product records under event 88847, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 21% of the 299 drug enforcement events initiated in 2021 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals has 3 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals, Burbank, CA.
Reason for recall
"Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label"
Distribution
"Nationwide in the USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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… | 119 Bottles | Class III | Ongoing | 1 Dec 2021 |
| 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… | 574 Bottles | Class III | Ongoing | 1 Dec 2021 |
Context
Other enforcement events for Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 12 Oct 2021 | Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count ( | Drug | Class I | 1 |
| 27 Jan 2021 | Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629 | Drug | Class I | 2 |
All 3 events for Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.