Solifenacin Succinate Tablets (Breckenridge) – Manufacturing Deviation (2020)
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
Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC 51991-894-90), Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pithampur 454 775, Dist, Dhar Madhya Pradesh, INDIA
Brand
Breckenridge Pharmaceutical, Inc
Lot Codes / Batch Numbers
Lot #: a) 81253, 81272, Exp. Date 01/2021 and b) 81268, Exp. Date 01/2021
Products Sold
Lot #: a) 81253, 81272, Exp. Date 01/2021 and b) 81268, Exp. Date 01/2021
Breckenridge Pharmaceutical, Inc is recalling Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-c due to CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.. 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: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
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 noticePage updated: Jan 7, 2026