CLASS II Drug recall · Reported 15 Nov 2023 · FDA Enforcement Report
Oxybutynin Chloride Extended-Release Tablet USP, 5 mg recalled
Zydus Pharmaceuticals (USA) is recalling Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, distributed nationwide in the US. The recall was initiated on 19 Oct 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0096-2024
- FDA event ID
- 93260
- Recalling firm
- Zydus Pharmaceuticals (USA), Pennington, NJ
- Brand
- Oxybutynin
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 19 Oct 2023
- FDA classified
- 8 Nov 2023
- Reported
- 15 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Bladder & Prostate Medication
Timeline
| 19 Oct 2023 | Recall initiated by company | |
| 8 Nov 2023 | Classified by FDA | +20 days |
| 15 Nov 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01
Where it was distributed
Nationwide.
Questions about this recall
Is Oxybutynin Chloride Extended-Release Tablet USP, 5 mg recalled?
Yes. Zydus Pharmaceuticals (USA) recalled Oxybutynin Chloride Extended-Release Tablet USP, 5 mg on 19 Oct 2023. The recall is Class II and its status is Completed. Recall number D-0096-2024.
Why was it recalled?
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Which lots are affected?
M212749, exp. date 11/2024; M214477, exp. date 11/2024; M214478, exp. date 11/2024; M214479, exp. date 11/2024; M214480, exp. date 11/2024
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zydus Pharmaceuticals (USA)
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals (USA) | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals (USA) | Potency & Assay | Nationwide |
Other Oxybutynin recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oxybutynin Chloride Extended-Release Tablet USP, 10 mg recalledOxybutynin | Zydus Pharmaceuticals (USA) | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxybutynin Chloride Extended-Release Tablet USP, 15 mg recalledOxybutynin | Zydus Pharmaceuticals (USA) | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) recalledOxybutynin | Zydus Pharmaceuticals (USA) | Potency & Assay | Nationwide |