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Class II · ModerateRecall completed

Oxybutynin

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot#: M300652 and M300651, exp. Dec 2024
Where it was soldNationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Dissolution Specifications

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byCadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534 foreign manufacturer
Brand nameOXYBUTYNIN
Generic nameOXYBUTYNIN
Active ingredient(s)OXYBUTYNIN CHLORIDE
Distributed by / forZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
NDC68382-256-01
Show the full FDA record
Full product labelOxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
Recalling firmZydus Pharmaceuticals (USA) Inc
DistributionNationwide in the USA.
Quantity7,248 bottles
Recall initiated2023-09-21
Report date2023-10-11
Recall completed2025-08-06
Recall numberD-0038-2024
ClassificationClass II
FDA statusTerminated
Origin on filePennington NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.