Zydus oxybutynin extended-release tablets recalled nationwide for failed stability testing
Zydus Pharmaceuticals is recalling specific lots of oxybutynin chloride extended-release 10 mg tablets nationwide due to out-of-specification dissolution test results at the 6-month stability timepoint. The affected tablets may not release medication properly.
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: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard—dissolution failure at the 6-month stability timepoint—is a manufacturing quality control issue affecting drug delivery, not an acute safety threat. The recall is precautionary based on testing results.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc is recalling specific lots of oxybutynin chloride extended-release tablets, 10 mg strength, distributed nationwide. The recall was initiated due to out-of-specification (OOS) dissolution test results observed at the 6-month long-term stability timepoint for the affected lots.
The failed dissolution testing indicates that tablets from these lots may not dissolve and release the active ingredient at the proper rate, which could affect the drug's therapeutic effectiveness. Oxybutynin is an anticholinergic medication used to treat overactive bladder symptoms.
The recalled lot numbers are: M213318, M213314, M213315, M214436, M214437, and M214438 (all expiring 11/2024); and M300653 and M300654 (expiring 12/2024). The product carries NDC #68382-256-01 and was manufactured by Cadila Healthcare Ltd in Baddi, India.
Patients taking oxybutynin from these lot numbers should contact their pharmacy or healthcare provider immediately. Do not stop taking the medication without consulting your doctor, as abruptly discontinuing your prescribed medication can be harmful.
The recalled product
- Product
- OXYBUTYNIN (OXYBUTYNIN)
- Brand
- OXYBUTYNIN
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Extended-release tablet
- Hazard
- dissolution-failure
- stability-issue
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 (10)
- M213318
- exp. date 11/2024
- M213314
- M213315
- M214436
- M214437
- M214438
- M300653
- exp. date 12/2024
- M300654
Distribution
Distributed nationwide across the United States.
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- ModerateOxybutynin Extended-Release Tablets Recalled for Failed Dissolution Test Results
FDA (Drugs) · 2023-11-15
- ModerateOxybutynin Extended-Release Tablets Recalled for Failed Dissolution Specifications
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