# FDA recall D-1050-2020

> **Breckenridge Pharmaceutical, Inc** · Class II · drug recall initiated 2020-01-24.

## 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.

## Distribution

Product was distributed nationwide within the United States.

## Key facts

- **Recall number:** D-1050-2020
- **Recalling firm:** Breckenridge Pharmaceutical, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-01-24
- **Report date:** 2020-03-25
- **Termination date:** 2020-10-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Berlin, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1050-2020

## Citation

> AI Analytics. FDA recall D-1050-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1050-2020. Source: US FDA. Licensed CC0.

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