Class II · Moderate risk
Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Is Darifenacin recalled?
Not under an active recall.
Darifenacin was recalled 3 times in the past — all now closed. Most recent: Mar 15, 2021.
Most common reason: Temperature excursion (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Darifenacin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Darifenacin recalls on record
none so far in 2026; 3 on record, newest first
Class II · Moderate risk
Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Enablex (darifenacin)
Failed Impurities/Degradation Specifications: unspecified degradation product
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