Solifenacin Succinate Tablets — Class II drug recall D-1050-2020
Terminated recall by Breckenridge Pharmaceutical, Inc, reported 2020-03-25, distributed nationwide. CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tabl
| Recall number | D-1050-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Breckenridge Pharmaceutical, Inc, Berlin, CT, United States |
| Recall initiated | 2020-01-24 |
| Classified | 2020-03-23 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2020-10-19 |
| Distributed | Nationwide (US) |
| Quantity | 11,250 bottles |
| Reason classes | cgmp |
| NDC | 51991-0893-33, 51991-0893-90 |
| Expiration dates | 2021-01 |
Product
Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33) and b) 90-count bottles (NDC 51991-893-90) 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
Reason for recall
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1050-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.