Class III · Low risk
Butalbital
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Butalbital
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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.
Affected NDCs
63629-8392-03
63629-8392-04
63629-8392-09
Compare with the code on your package — it is the most precise check available.
Drug: Butalbital
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Butalbital, Acetaminophen, and Caffeine NDC 63629-8392 |
BUTALBITAL 50 mg/1; ACETAMINOPHEN 325 mg/1; CAFFEINE 40 mg/1 | Tablet Oral |
Bryant Ranch Prepack | Rx · CIII |
- Recalling firm
- Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0256-2022 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Butalbital recalls
See all
Class II · Moderate risk
Acetaminophen/ Butalbital/ Caffeine
Labeling: Label Mixup: ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 mg/50 mg/40 mg may have potentially been mislabeled as the following drug: ASPIRIN, Tablet, 325 mg, NDC 49348000123, Pedigree: W002640, EXP: 6/4/2014.
Other recalls by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
All 2021 recalls
Class III · Low risk
Cephalexin for Oral Suspension
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Class III · Low risk
Cephalexin for Oral Suspension
Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
Class III · Low risk
Cephalexin for Oral Suspension
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Class III · Low risk
Cephalexin for Oral Suspension
Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
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