Drospirenone recalls

The FDA has published 3 recalls involving Drospirenone since 2019. The latest was reported on 9 Aug 2023. Most were for potency & assay. Lupin Pharmaceuticals 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 I267% of total

Ongoing0latest 9 Aug 2023

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

Why drospirenone is recalled

Potency & Assay267%
Packaging Defects133%

Companies

By year

2023133%
2019267%

All drospirenone recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
9 Aug 2023Drug	CLASS I	Tydemy (drospirenone, ethinyl estradiol recalledTydemy	Lupin Pharmaceuticals	Potency & Assay	Nationwide
7 Aug 2019Drug	CLASS I	Drospirenone and Ethinyl Estradiol Tablets recalled by Jubilant Cadista	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
13 Mar 2019Drug	CLASS II	Drospirenone and Ethinyl Estradiol Tablets recalled by Apotex	Apotex	Packaging Defects	Nationwide

Should you stop taking Drospirenone?

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.