Most common reason: Labeling / mix-up (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Mexiletine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
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.
Labeling: Label Mixup: MEXILETINE HCL, Capsule, 200 mg may have potentially been mislabeled as the following drug: ISOSORBIDE DINITRATE, Tablet, 10 mg, NDC 00781155601, Pedigree: AD25264_1, EXP: 5/3/2014.
Labeling: Label Mixup: MEXILETINE HCL, Capsule, 150 mg may have potentially been mislabeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD62865_4, EXP: 5/23/2014.
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