Prescription Oxybutynin Extended-Release Tablets Recalled for Dissolution Failure
Zydus Pharmaceuticals is recalling Oxybutynin extended-release tablets due to failed dissolution testing. The tablets may not dissolve properly, potentially affecting drug efficacy.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for pharmaceutical quality defect (failed dissolution specifications). No illnesses or injuries reported. The hazard is a risk-of-harm product where drug efficacy may be compromised, meeting the High severity criterion.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc is recalling Oxybutynin Chloride Extended-Release Tablets, 5 mg, in 100-count bottles (NDC 68382-255-01 and related package sizes). The recalled batches are M212749, M214477, M214478, M214479, and M214480, all with expiration dates of November 2024. The tablets are manufactured by Cadila Healthcare Ltd in Baddi, India.
The recall was initiated after out-of-specification (OOS) test results were observed for dissolution at the 6-month time point during long-term stability testing. This means the tablets failed to meet required dissolution specifications, which ensure the medication dissolves properly in the body for absorption and therapeutic benefit.
Oxybutynin is a prescription medication used to treat overactive bladder. The recall affects patients nationwide who may have received the affected batches. Patients taking Oxybutynin from these batches should consult with their healthcare provider or pharmacist before stopping their medication or switching to an alternative product.
The recalled product
- Product
- OXYBUTYNIN (OXYBUTYNIN)
- Brand
- OXYBUTYNIN
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Prescription Medication
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 (6)
- M212749
- exp. date 11/2024
- M214477
- M214478
- M214479
- M214480
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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