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.
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 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
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.
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
Same brand · OXYBUTYNIN
- 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
- ModerateOxybutynin Extended-Release Tablets Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2023-10-11
Same manufacturer · Zydus Pharmaceuticals (USA) Inc
See all →- SevereZydus Recalls Hydrocortisone Sodium Succinate Injection for Impurity Failures
FDA (Drugs) · 2026-10-21
- SevereFDA Recalls Mirabegron Tablets Over Nitrosamine Impurity
FDA (Drugs) · 2026-08-12
- SevereErythromycin 500 mg Tablets Recalled for Impurity Above Limits
FDA (Drugs) · 2026-05-27
- SevereErythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
- HighIcosapent ethyl capsules recalled after active ingredient oxidized inside capsule
FDA (Drugs) · 2026-03-18
Same hazard · dissolution failure
See all →- ModerateAscend Recalls Amlodipine and Olmesartan Medoxomil Tablets for Dissolution Issues
FDA (Drugs) · 2026-10-28
- ModerateApotex Recalls Paroxetine Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateAjanta Pharma Recalls Ranolazine Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- 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
Similar recalls
- ModerateOxybutynin Extended-Release Tablets Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2023-10-11
- ModerateLannett Recalls Oxybutynin Chloride Tablets for Dissolution Failures
FDA (Drugs) · 2019-03-20
- LowAvKARE Recalls Oxybutynin Chloride Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2019-03-20
- LowSandoz Recalls Orphenadrine Citrate Tablets for Dissolution Failures
FDA (Drugs) · 2014-07-30
- LowZydus Recalls Bupropion Hydrochloride Extended-Release Tablets for Dissolution Failures
FDA (Drugs) · 2016-12-28
- HighZileuton Extended-Release Tablets recalled for failed dissolution specifications
FDA (Drugs) · 2022-06-22