Class III · Low risk
Butalbital
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Is Butalbital recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Butalbital (3 total). Check the affected lots below.
Most common reason: Labeling / mix-up (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Butalbital. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Butalbital recalls on record
none so far in 2026; 3 on record, newest first
Class III · Low risk
Butalbital
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
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.
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