Class II · Moderate risk
Oxybutynin Chloride Extended-Release Tablet USP
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Oxybutynin Chloride Extended-Release Tablets USP 10 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Oxybutynin 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
Affected NDCs
68382-0256-01
68382-0256-05
Compare with the code on your package — it is the most precise check available.
Drug: Oxybutynin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| oxybutynin NDC 68382-0256 |
CHLORIDE 10 mg/1 | Tablet, Film Coated, Extended Release Oral |
Zydus Pharmaceuticals USA Inc. | Rx |
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- NDC code
- 68382-256-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0038-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Oxybutynin recalls
See all
Class II · Moderate risk
Oxybutynin Chloride Extended-Release Tablet USP
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II · Moderate risk
Oxybutynin Chloride Extended-Release Tablet USP
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class III · Low risk
Oxybutynin Chloride Extended-Release Tablets USP 10 mg
Failed Dissolution Specifications
Class III · Low risk
Oxybutynin Chloride
Failed Dissolution Specifications
Other recalls by Zydus Pharmaceuticals (USA) Inc
All 2023 recalls
Class II · Moderate risk
Mirabegron Extended-Release Tablets
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Class II · Moderate risk
Erythromycin Tablets
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class II · Moderate risk
Erythromycin Tablets
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class II · Moderate risk
Icosapent Ethyl Capsules
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
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