Oxybutynin Extended-Release Tablets Recalled for Failed Dissolution Test Results
Zydus Pharmaceuticals is recalling Oxybutynin Extended-Release Tablets (15 mg) after dissolution testing showed out-of-specification results at the 6-month mark. No illnesses have been reported.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class II recall based on a specification failure (failed dissolution test) detected during stability testing. No illnesses or injuries have been reported. The issue is a manufacturing quality control finding rather than an immediately apparent safety threat.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc is recalling Oxybutynin Chloride Extended-Release Tablets USP, 15 mg, in 100-count bottles (NDC 68382-257-01) distributed nationwide. The product was manufactured by Cadila Healthcare Ltd in Baddi, India. The recall affects four lots: M211541, M211542, and M212746 (all expiring 10/2024) and M300660 (expiring 12/2024).
The recall was initiated after long-term stability testing revealed that the product failed to meet its dissolution specifications at the 6-month time point. Dissolution testing verifies that tablets break down and release their active ingredients as intended.
Patients currently taking oxybutynin should check their medication labels against the affected lot numbers. Those with affected medication should contact their healthcare provider for guidance on alternatives or replacement supply. Healthcare facilities and pharmacies should identify and quarantine affected inventory for return to the distributor. No illnesses or adverse health events have been reported in connection with this recall.
The recalled product
- Product
- OXYBUTYNIN (OXYBUTYNIN)
- Brand
- OXYBUTYNIN
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Oral / Extended-Release
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 (5)
- M211541
- exp. date 10/2024 M211542
- exp. date 10/2024 M212746
- exp. date 10/2024 M300660
- exp. date 12/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Zydus Pharmaceuticals (USA) Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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