Class II
Terminated
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
This recall has been terminated (originally issued March 25, 2020).
- Company
- Breckenridge Pharmaceutical, Inc
- Recall Initiated
- January 24, 2020
- Posted
- March 25, 2020
- Recall Number
- D-1050-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,250 bottles
- Firm Location
- Berlin, CT, United States
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot #: a) 81244, 81217, Exp. Date 01/2021 and b) 81245, Exp. Date 01/2021
More recalls by Breckenridge Pharmaceutical, Inc
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Ph...
Apr 30, 2025 · Class II
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. b...
Jan 1, 2025 · Class II
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceut...
Oct 23, 2024 · Class II
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...
Leo Pharma Inc
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026