Breckenridge Pharmaceutical, Inc recalls Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC
Breckenridge Pharmaceutical recalls 10mg Solifenacin Succinate tablets due to manufacturing error that may convert to a different, potentially harmful form. Affected products have specific NDC numbers and expiration dates.
Recall notice
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Contact the company & request your remedy
What happened, in plain English
Breckenridge Pharmaceutical is recalling 10mg Solifenacin Succinate tablets that might convert to a different chemical form during manufacturing. This could cause the medication to be ineffective or harmful if taken. The recall affects specific bottle sizes and expiration dates. Read more at govinfonow.com/recall/37401-breckenridge-solifenacin-tablets-recall-possible-conversion-to-harmful-form.
Source Summary by GovInfoNow · govinfonow.com/recall/37401-breckenridge-solifenacin-tablets-recall-possible-conversion-to-harmful-form · Updated October 5, 2026 · FDA enforcement record: FDA #D-1051-2020
Cite this page
“Breckenridge Solifenacin Tablets Recall: Possible Conversion to Harmful Form.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37401-breckenridge-solifenacin-tablets-recall-possible-conversion-to-harmful-form. Based on FDA recall #D-1051-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1051-2020%22&limit=1).
Why it’s dangerous
During manufacturing, the tablets might convert to a different chemical form (Solifenacin Tartrate) that could be ineffective or harmful. This conversion happens due to a manufacturing error that affects the product's safety and effectiveness.
Who’s affected
People who own the recalled 30-count or 90-count bottles of 10mg Solifenacin Succinate tablets with the listed NDC numbers and expiration dates are affected. Those who have taken the medication without knowing it's recalled are at risk.
How to tell if you have this one
Check for 30-count bottles (NDC 51991-894-33) or 90-count bottles (NDC 51991-894-90) with expiration dates of January 2021. The product was distributed by Breckenridge Pharmaceutical, Inc. in the US.
- Brand
Breckenridge- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Product was distributed nationwide within the United States.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1050-2020 | 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; Lot #: a) 81244, 81217, Exp. Date 01/2021 and b) 81245, Exp. Date 01/2021 | 11,250 bottles |
| D-1051-2020 | 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 Pithampur 454 775, Dist, Dhar Madhya Pradesh, INDIA; Lot #: a) 81253, 81272, Exp. Date 01/2021 and b) 81268, Exp. Date 01/2021 | 11, 250 bottles |
What to do — step by step
Check Product Details
Verify the product's NDC number and expiration date to confirm if it's affected.
Questions people ask
Why is this product being recalled?
The recall is due to a manufacturing error where Solifenacin Succinate tablets might convert to Solifenacin Tartrate tablets, which could be ineffective or harmful.
What should I do if I have the recalled product?
The official recall notice does not specify a remedy, so you should check with Breckenridge Pharmaceutical for further instructions.
Are there any safety risks from taking the recalled product?
The recall indicates a potential conversion to a different form that could be ineffective or harmful, but the exact risk level is not specified.
Contact Breckenridge
We’ve drafted a message you can send Breckenridge to request your refund or repair — edit it as you like.
Subject: Recall D-1051-2020 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-1051-2020 from Breckenridge. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1051-2020 (January 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1051-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.