Pioglitazone recalls

The FDA has published 3 recalls involving Pioglitazone since 2019. The latest was reported on 2 Feb 2022. Most were for potency & assay. Macleods Pharma Usa has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls3since 2019

Last 12 months0reported

Class I00% of total

Ongoing0latest 2 Feb 2022

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 67%Class III 1 33%

Why pioglitazone is recalled

Potency & Assay3100%

Companies

Macleods Pharma Usa267%
Aurobindo Pharma USA133%

Brands

By year

2022133%
2020133%
2019133%

All pioglitazone recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
2 Feb 2022Drug	CLASS II	Pioglitazone Tablets USP, 45 mg recalled by Aurobindo Pharma USAPioglitazone	Aurobindo Pharma USA	Potency & Assay	Nationwide
12 Feb 2020Drug	CLASS III	Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg recalledPioglitazone And Metformin Hydrochloride	Macleods Pharma Usa	Potency & Assay	Nationwide
23 Oct 2019Drug	CLASS II	Pioglitazone Hydrochloride Tablets USP 15 mg recalledPioglitazone	Macleods Pharma Usa	Potency & Assay	NJ

Should you stop taking Pioglitazone?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.