Class II · Moderate risk
Pioglitazone Tablets USP
Superpotent and Failed Tablet/Capsule Specifications
Is Pioglitazone recalled?
Not under an active recall.
Pioglitazone was recalled 9 times in the past — all now closed. Most recent: Dec 29, 2021.
Most common reason: Wrong potency / content (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pioglitazone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Pioglitazone recalls on record
none so far in 2026; 9 on record, newest first
Class III · Low risk
Pioglitazone and Metformin Hydrochloride Tablets
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Class II · Moderate risk
Pioglitazone Hydrochloride Tablets USP 15 mg
Superpotent
Class II · Moderate risk
Actoplus met XR
Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.
Class II · Moderate risk
PIO&METFORMIN 15/1000 mg Tab 1
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Pioglitazone and Glimepiride Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Pioglitazone HCl active pharmaceutical ingredient packaged in…
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
Pioglitazone
Labeling: Label Mixup: PIOGLITAZONE, Tablet, 15 mg may have potentially been mislabeled as one of the following drugs: LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: AD21846_31, EXP: 5/1/2014; PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD25452_7, EXP: 5/3/2014; ARIPiprazole, Tablet, 15 mg, NDC 59148000913, Pedigree: AD28322_1, EXP: 5/6/2014.
Class II · Moderate risk
Pioglitazone HCL
Labeling: Label Mixup: PIOGLITAZONE HCL, Tablet, 15 mg may have potentially been mislabeled as one of the following drugs: DOXYCYCLINE MONOHYDRATE, Capsule, 100 mg, NDC 49884072703, Pedigree: AD52778_25, EXP: 5/20/2014; LOVASTATIN, Tablet, 20 mg, NDC 00185007201, Pedigree: W003263, EXP: 6/17/2014.
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