Class II · Moderate risk
Sotalol HCL Tablets
Presence of particulate matter. presence of metal particles.
Is Sotalol recalled?
Not under an active recall.
Sotalol was recalled 4 times in the past — all now closed. Most recent: Mar 9, 2020.
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 Sotalol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Sotalol recalls on record
none so far in 2026; 4 on record, newest first
Class II · Moderate risk
Sotalol HCL
Labeling: Label Mixup: SOTALOL HCL, Tablet, 160 mg may have potentially been mislabeled as the following drug: DISULFIRAM, Tablet, 250 mg, NDC 64980017101, Pedigree: AD22609_1, EXP: 5/2/2014.
Class II · Moderate risk
Sotalol HCL
Labeling: Label Mixup: SOTALOL HCL, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: DILTIAZEM HCL, Tablet, 120 mg, NDC 00093032101, Pedigree: AD30197_1, EXP: 5/9/2014; PROPRANOLOL HCL ER, Capsule, 60 mg, NDC 00228277811, Pedigree: AD54605_4, EXP: 5/20/2014.
Class II · Moderate risk
Sotalol HCL
Labeling: Label Mixup: SOTALOL HCL, Tablet, 120 mg may have potentially been mislabeled as the following drug: NEOMYCIN SULFATE, Tablet, 500 mg, NDC 51991073801, Pedigree: AD49448_17, EXP: 5/17/2014.
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