CLASS II Drug recall · Reported 21 Jul 2021 · FDA Enforcement Report
Solifenacin Succinate Tablets, 10 mg recalled by CIPLA
CIPLA is recalling Solifenacin Succinate Tablets, 10 mg, distributed nationwide in the US. The recall was initiated on 10 Jun 2021 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-0660-2021
- FDA event ID
- 88090
- Recalling firm
- CIPLA, Warren, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jun 2021
- FDA classified
- 15 Jul 2021
- Reported
- 21 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Bladder & Prostate Medication
Timeline
| 10 Jun 2021 | Recall initiated by company | |
| 15 Jul 2021 | Classified by FDA | +35 days |
| 21 Jul 2021 | Published in enforcement report | +6 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
Product as listed by the FDA
Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufactured for Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL, 33323, NDC 69097-261-02.
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Solifenacin Succinate Tablets, 10 mg recalled?
Yes. CIPLA recalled Solifenacin Succinate Tablets, 10 mg on 10 Jun 2021. The recall is Class II and its status is Terminated. Recall number D-0660-2021.
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot #: GG90819, Exp. Date 06/2021
Where was it sold?
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Solifenacin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Solifenacin Succinate Tablets 10MG recalled by Glenmark PharmaceuticalsSolifenacin Succinate | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Solifenacin Succinate Tablets 5mg, a.) bottle recalledSolifenacin Succinate | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Solifenacin Succinate Tablets, 5mg recalled | Breckenridge Pharmaceutical | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Solifenacin Succinate Tablets, 10 mg 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 |