Class II · ModerateRecall completed
Oxybutynin
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberM211541, exp. date 10/2024 M211542, exp. date 10/2024 M212746, exp. date 10/2024 M300660, exp. date 12/2024
Where it was soldNationwide.
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-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byCadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc foreign manufacturer
| Brand name | OXYBUTYNIN |
| Generic name | OXYBUTYNIN |
| Active ingredient(s) | OXYBUTYNIN CHLORIDE |
| Distributed by / for | Zydus Pharmaceuticals (USA) Inc |
| NDC | 68382-257-01 |
Show the full FDA record
| Full product label | Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01. |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc |
| Distribution | Nationwide. |
| Recall initiated | 2023-10-19 |
| Report date | 2023-11-15 |
| Recall completed | — |
| Recall number | D-0098-2024 |
| Classification | Class II |
| FDA status | Completed |
| Origin on file | Pennington NJ United States |
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.