Darifenacin Extended-release Tablets (Cardinal Health) – temperature deviation (2021)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured by: Torrent Pharmaceuticals LTD. Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-202-30
Brand
Cardinal Health Inc.
Lot Codes / Batch Numbers
BDZ7G005
Products Sold
BDZ7G005
Cardinal Health Inc. is recalling Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured by: Torrent Pharmaceutic due to CGMP Deviations: Intermittent exposure to temperature excursion during storage.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, GA, SC
Page updated: Jan 7, 2026