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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Breckenridge Pharmaceutical, Inc: Solifenacin Succinate Tablets Recalled Due to Potential Chemical Conversion

Agency Publication Date: March 19, 2020
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Summary

Breckenridge Pharmaceutical is recalling approximately 22,500 bottles of Solifenacin Succinate (generic VESIcare), a medication used to treat overactive bladder. The recall was issued because a manufacturing error may have caused the medication to convert into Solifenacin Tartrate, a different chemical form that does not meet the approved product specifications. This recall affects both 5mg and 10mg tablets in 30-count and 90-count bottles that were distributed nationwide throughout the United States. Consumers should check their prescription bottles immediately to see if their medication is part of the affected lots.

Risk

The drug may have converted to a different chemical salt (tartrate instead of succinate) during manufacturing, meaning the medication does not meet regulated quality standards and its intended effectiveness or safety profile may be altered.

What You Should Do

  1. Check your medication bottle for Solifenacin Succinate Tablets, 5mg. Affected products include 30-count bottles (NDC 51991-893-33) with lot numbers 81244 or 81217, and 90-count bottles (NDC 51991-893-90) with lot number 81245. All affected 5mg lots have an expiration date of 01/2021.
  2. Check your medication bottle for Solifenacin Succinate Tablets, 10mg. Affected products include 30-count bottles (NDC 51991-894-33) with lot numbers 81253 or 81272, and 90-count bottles (NDC 51991-894-90) with lot number 81268. All affected 10mg lots have an expiration date of 01/2021.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription if your medication is part of the recall.
  4. Return any unused or affected medication to your pharmacy to request a refund and ensure the product is disposed of correctly.
  5. Contact Breckenridge Pharmaceutical, Inc. at their Berlin, Connecticut headquarters for further instructions regarding this recall.
  6. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Pharmacy refund and healthcare consultation.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Solifenacin Succinate Tablets, 5mg (30-count bottle)
Model:
NDC 51991-893-33
Recall #: D-1050-2020
Lot Numbers:
81244 (Exp. Date 01/2021)
81217 (Exp. Date 01/2021)
Date Ranges: 01/2021
Product: Solifenacin Succinate Tablets, 5mg (90-count bottle)
Model:
NDC 51991-893-90
Recall #: D-1050-2020
Lot Numbers:
81245 (Exp. Date 01/2021)
Date Ranges: 01/2021
Product: Solifenacin Succinate Tablets, 10 mg (30-count bottle)
Model:
NDC 51991-894-33
Recall #: D-1051-2020
Lot Numbers:
81253 (Exp. Date 01/2021)
81272 (Exp. Date 01/2021)
Date Ranges: 01/2021
Product: Solifenacin Succinate Tablets, 10 mg (90-count bottle)
Model:
NDC 51991-894-90
Recall #: D-1051-2020
Lot Numbers:
81268 (Exp. Date 01/2021)
Date Ranges: 01/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85186
Status: Resolved
Manufacturer: Breckenridge Pharmaceutical, Inc
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 2 products (11,250 bottles; 11, 250 bottles)
Distributed To: Nationwide
Agency Last Updated: March 23, 2020

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.