The Recall Desk
ModerateFDA (Drugs)·D-1051-2020·Announced 2020-03-25

Breckenridge Recalls Solifenacin Succinate Tablets Due to Manufacturing Deviations

Breckenridge Pharmaceutical is recalling specific lots of Solifenacin Succinate Tablets because manufacturing deviations may have resulted in the production of Solifenacin Tartrate.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a manufacturing deviation resulting in a different chemical salt form, which is a significant quality issue but does not involve high-risk pathogens or immediate life-threatening hazards like choking or fire.

Plain-English summary

Breckenridge Pharmaceutical, Inc. is recalling 11,250 bottles of Solifenacin Succinate Tablets, 10 mg. The affected products are distributed in 30-count bottles (NDC 51991-894-33) and 90-count bottles (NDC 51991-894-90). The specific lots involved are 81253 and 81272 (expiration date 01/2021) and 81268 (expiration date 01/2021). The product was distributed nationwide within the United States.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations during the manufacturing process. The source text indicates that Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets during manufacturing. This deviation results in the product potentially being a different chemical salt form than labeled.

Consumers should check their medication for the specific NDC numbers and lot numbers listed above. If the product matches the recalled description, consumers should stop using it and contact their pharmacist or healthcare provider for guidance on replacement or disposal.

The recalled product

Product
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 Pith
Manufacturer
Breckenridge Pharmaceutical, Inc
Category
Drug — Prescription Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #: a) 81253
  • 81272
  • Exp. Date 01/2021 and b) 81268
  • Exp. Date 01/2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Breckenridge Pharmaceutical, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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