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.
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
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.
The label is missing the controlled substance classification 'CIII', which is required by law for certain prescription drugs. This could lead to incorrect classification of the product, but it does not cause immediate harm or injury.
People who have the recalled Butalbital tablets (12-count, 20-count, 30-count, 60-count, 90-count, or 120-count bottles) may be affected. Those who use prescription pain relief medications are most at risk due to potential misclassification.
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.
Identify the product by checking the NDC codes (71335-1767-09 to 71335-1767-07) or barcodes on the packaging.
The label is missing the controlled substance classification 'CIII', which is required by law for certain prescription drugs.
No, the recall is for labeling compliance, not an immediate safety hazard.
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 with the listed NDC codes or barcodes.
We’ve drafted a message you can send BRP Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0257-2022 — BRP Pharmaceuticals BRP Pharmaceuticals Hello, I own a BRP Pharmaceuticals that is covered by recall D-0257-2022 from BRP Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
