Oxybutynin Extended-Release Tablets Recalled for Failed Dissolution Specifications
Zydus Pharmaceuticals recalls Oxybutynin Chloride Extended-Release Tablets 10 mg nationwide because the medication failed dissolution specifications. Affected lot numbers: M300652 and M300651.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II drug recall with failed dissolution specifications affecting medication efficacy. No reported illnesses or injuries documented in source material, and the hazard is a quality/manufacturing issue rather than direct contamination or safety threat.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling Oxybutynin Chloride Extended-Release Tablets USP 10 mg in bottles of 100 and 500 tablets due to failed dissolution specifications. The tablets do not dissolve as intended, which affects how the medication is absorbed in the body. This recall affects 7,248 bottles distributed nationwide in the United States.
The recalled product includes bottles of 100 tablets (NDC 68382-256-01) and 500 tablets (NDC 68382-256-05). The affected lot numbers are M300652 and M300651, with expiration dates in December 2024. The medication was manufactured by Cadila Healthcare Ltd. in Ahmedabad, India, and distributed by Zydus Pharmaceuticals (USA) Inc. in Pennington, New Jersey.
Patients and healthcare providers with affected batches should contact Zydus Pharmaceuticals (USA) Inc. for further guidance. The FDA is monitoring the recall.
The recalled product
- Product
- OXYBUTYNIN (OXYBUTYNIN)
- Brand
- OXYBUTYNIN
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug
- Affected units
- 7,248
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: M300652 and M300651
- exp. Dec 2024
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · OXYBUTYNIN
- ModerateZydus oxybutynin extended-release tablets recalled nationwide for failed stability testing
FDA (Drugs) · 2023-11-15
- HighPrescription Oxybutynin Extended-Release Tablets Recalled for Dissolution Failure
FDA (Drugs) · 2023-11-15
- ModerateOxybutynin Extended-Release Tablets Recalled for Failed Dissolution Test Results
FDA (Drugs) · 2023-11-15
Same manufacturer · Zydus Pharmaceuticals (USA) Inc
See all →- SevereFDA Recalls Mirabegron Tablets Over Nitrosamine Impurity
FDA (Drugs) · 2026-08-12
- SevereErythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
- SevereErythromycin 500 mg Tablets Recalled for Impurity Above Limits
FDA (Drugs) · 2026-05-27
- HighIcosapent ethyl capsules recalled after active ingredient oxidized inside capsule
FDA (Drugs) · 2026-03-18
- HighIcosapent ethyl capsules recalled as subpotent after capsule contents leaked
FDA (Drugs) · 2026-01-28
Same hazard · dissolution failure
See all →- ModerateMylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures
FDA (Drugs) · 2026-09-09
- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
- ModerateChlorthalidone 25mg tablets failed dissolution specifications in two batches
FDA (Drugs) · 2026-06-24
- ModerateNiacin extended-release tablets failed dissolution testing at 24 hours
FDA (Drugs) · 2026-06-17