Class III · Low risk
Digoxin Tablets
Failed Impurities/Degradation Specifications
Is Digoxin recalled?
Not under an active recall.
Digoxin was recalled 7 times in the past — all now closed. Most recent: Mar 25, 2024.
Most common reason: Labeling / mix-up (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Digoxin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Digoxin recalls on record
none so far in 2026; 7 on record, newest first
Class III · Low risk
Digoxin Tablets
Cross Contamination with Other Products:(mycophenolate mofetil).
Class II · Moderate risk
Digoxin Tablets
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Class I · High risk
Digoxin Tablets
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Class II · Moderate risk
Digoxin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums
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
Digoxin
Labeling: Label Mixup: DIGOXIN, Tablet, 125 mcg may have potentially been mislabeled as the following drug: CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS, Tablet, 120 units/105 mg/81 mg, NDC 64980015001, Pedigree: W002581, EXP: 6/3/2014.
Class II · Moderate risk
Digoxin
Labeling: Label Mixup: DIGOXIN, Tablet, 0.125 mg may have potentially been mislabeled as one of the following drugs: MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD21846_34, EXP: 5/1/2014; DESMOPRESSIN ACETATE, Tablet, 0.1 mg, NDC 00591246401, Pedigree: AD46426_16, EXP: 5/15/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 00603548221, Pedigree: AD60264_1, EXP: 5/22/2014; LIOTHYRONINE SODIUM,
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