Class III · Low risk
Disulfiram tablets
Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.
Is Disulfiram recalled?
Not under an active recall.
Disulfiram was recalled 4 times in the past — all now closed. Most recent: Jun 18, 2015.
Most common reason: cGMP deviation (1 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Disulfiram. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Disulfiram recalls on record
none so far in 2026; 4 on record, newest first
Class II · Moderate risk
Disulfiram active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
DISULFIRAM Tablet
Labeling: Label Mixup; DISULFIRAM Tablet, 250 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD22865_22, EXP: 5/2/2014.
Class III · Low risk
Disulfiram Tablets USP 250 mg
CGMP Deviation; cotton coil is missing in some packaged bottles
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