Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules
CGMP Deviations
Is Propafenone recalled?
Yes — there is an active recall. 4 ongoing FDA recalls mention Propafenone (6 total). Check the affected lots below.
Most common reason: cGMP deviation (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Propafenone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Propafenone recalls on record
none so far in 2026; 6 on record, newest first
Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules USP
CGMP Deviations
Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules 325mg
CGMP Deviations
Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules 225mg
CGMP Deviations
Class III · Low risk
Propafenone Hydrochloride tablets
Failed moisture limits: Out of specification for moisture content.
Class II · Moderate risk
Propafenone HCL
Labeling: Label Mixup: PROPAFENONE HCL, Tablet, 150 mg may have potentially been mislabeled as the following drug: FOSINOPRIL SODIUM, Tablet, 10 mg, NDC 00185004109, Pedigree: AD54549_7, EXP: 5/20/2014.
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