AVKARE Inc. recalls Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC
AVKARE recalls Oxybutynin Chloride Extended-Release Tablets USP 10 mg (100 and 500 tablets) due to failed dissolution specifications. These prescription-only tablets may not release medication properly.
Lower-risk recall
Failed Dissolution Specifications
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What happened, in plain English
AVKARE is recalling Oxybutynin Chloride Extended-Release Tablets USP 10 mg (100 and 500 tablet packs) because they failed dissolution specifications. This means the medication might not release properly as intended, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/39138-avkare-oxybutynin-chloride-tablets-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/39138-avkare-oxybutynin-chloride-tablets-recall-failed-dissolution-specifications · Updated October 5, 2026 · FDA enforcement record: FDA #D-0990-2019
Cite this page
“AVKARE Oxybutynin Chloride Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39138-avkare-oxybutynin-chloride-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-0990-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0990-2019%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications, meaning they may not release medication as intended. This could lead to improper treatment effectiveness but does not cause immediate harm or injury.
Who’s affected
Prescription patients who have the specific Oxybutynin Chloride Extended-Release Tablets USP 10 mg (100 or 500 tablets) with NDC 42291-634-01 or 42291-634-50. Patients using these tablets for overactive bladder treatment are most at risk.
How to tell if you have this one
Check for Oxybutynin Chloride Extended-Release Tablets USP 10 mg with NDC 42291-634-01 (100 tablets) or NDC 42291-634-50 (500 tablets). These are prescription-only products manufactured by AVKARE Inc. in Pulaski, TN.
- Brand
AVKARE- Category
Drug
What to do — step by step
Check Product Details
Verify the product label for NDC 42291-634-01 or 42291-634-50 to confirm it is affected.
Questions people ask
Why is this product being recalled?
The product failed dissolution specifications, meaning it may not release medication properly as intended.
What should I do if I have this product?
Check the product label for NDC 42291-634-01 or 42291-634-50. If you have the affected product, contact your healthcare provider for guidance.
Is there a risk of injury from this product?
The recall is for potential treatment effectiveness issues, not immediate injury risks. The hazard does not cause serious injury.
Contact AVKARE
We’ve drafted a message you can send AVKARE to request your refund or repair — edit it as you like.
Subject: Recall D-0990-2019 — AVKARE AVKARE Hello, I own a AVKARE that is covered by recall D-0990-2019 from AVKARE. 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-0990-2019 (March 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0990-2019 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.