The Recall Desk
ModerateFDA (Drugs)·D-1050-2020·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 product converting to 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, and the source text describes a manufacturing deviation without reporting any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Breckenridge Pharmaceutical, Inc. is recalling 11,250 bottles of Solifenacin Succinate Tablets, 5mg. The affected products are packaged in 30-count bottles (NDC 51991-893-33) and 90-count bottles (NDC 51991-893-90). The specific lots involved are 81244 and 81217 (30-count) and 81245 (90-count), all with an expiration date of 01/2021.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. During the manufacturing process, the Solifenacin Succinate Tablets might have converted to Solifenacin Tartrate Tablets. The product was distributed nationwide within the United States.

Consumers should check their medication for the specific NDC, lot numbers, and expiration dates listed above. If they possess the affected product, they should stop using it and contact their healthcare provider or pharmacist for guidance on next steps.

The recalled product

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 Pithampu
Manufacturer
Breckenridge Pharmaceutical, Inc
Category
Drug — Prescription Medication
Hazard
Affected units
11,250

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) 81244
  • 81217
  • Exp. Date 01/2021 and b) 81245
  • 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 →

Related recalls

Same manufacturer · Breckenridge Pharmaceutical, Inc

See all →

Same hazard · manufacturing deviation

See all →