CLASS II Drug recall · Reported 25 Mar 2020 · FDA Enforcement Report
Solifenacin Succinate Tablets, 10 mg recalled
Breckenridge Pharmaceutical is recalling Solifenacin Succinate Tablets, 10 mg, distributed nationwide in the US. The recall was initiated on 24 Jan 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1051-2020
- FDA event ID
- 85186
- Recalling firm
- Breckenridge Pharmaceutical, Berlin, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jan 2020
- FDA classified
- 23 Mar 2020
- Reported
- 25 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Bladder & Prostate Medication
Timeline
| 24 Jan 2020 | Recall initiated by company | |
| 23 Mar 2020 | Classified by FDA | +59 days |
| 25 Mar 2020 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Product as listed by the FDA
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
Where it was distributed
Product was distributed nationwide within the United States.
Questions about this recall
Why was it recalled?
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Which lots are affected?
Lot #: a) 81253, 81272, Exp. Date 01/2021 and b) 81268, Exp. Date 01/2021
Where was it sold?
Product was distributed nationwide within the United States.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 85186| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Solifenacin Succinate Tablets, 5mg recalled | Breckenridge Pharmaceutical | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Breckenridge Pharmaceutical
All 35| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules USP, 60mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
Other Solifenacin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Solifenacin Succinate Tablets 10MG, a. bottle recalledSolifenacin Succinate | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Solifenacin Succinate Tablets 5mg, a.) bottle recalledSolifenacin Succinate | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Solifenacin Succinate Tablets, 10 mg recalled by CIPLA | Cipla | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Solifenacin Succinate Tablets, 5mg recalled | Breckenridge Pharmaceutical | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Solifenacin Succinate Tablet, 5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |