Class I · High risk
Tydemy
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Is Drospirenone recalled?
Not under an active recall.
Drospirenone was recalled 6 times in the past — all now closed. Most recent: Jun 23, 2023.
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 Drospirenone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Drospirenone recalls on record
none so far in 2026; 6 on record, newest first
Class III · Low risk
Tydemy
Subpotent Drug
Class I · High risk
Drospirenone and Ethinyl Estradiol Tablets
Failed dissolution specifications : failed results at the 3-month stability time point.
Class II · Moderate risk
Drospirenone and Ethinyl Estradiol Tablets
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Class II · Moderate risk
ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
Class III · Low risk
Syeda (drospirenone and ethinyl estradiol)
Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.
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