Lannett Recalls Oxybutynin Chloride Tablets for Dissolution Failures
Lannett Company Inc. is recalling 14,448 bottles of Oxybutynin Chloride Extended-Release Tablets because they failed to meet dissolution specifications.
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: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct safety threat like contamination or mislabeling of a common allergen.
Plain-English summary
Lannett Company Inc. is recalling 14,448 bottles of Oxybutynin Chloride Extended-Release Tablets USP, 10 mg. The affected product is distributed nationwide, including Puerto Rico. The recall involves specific lots: 18226783A (exp 07/2021) and 18232540A (exp 08/2021).
The recall was initiated because the tablets failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the drug releases its active ingredient at the intended rate. When this specification is not met, the medication may not work as intended.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be returned to the pharmacy or distributor for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- OXYBUTYNIN CHLORIDE (OXYBUTYNIN CHLORIDE)
- Brand
- OXYBUTYNIN CHLORIDE
- Manufacturer
- Lannett Company Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 14,448
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 (3)
- Lots: 18226783A
- exp 07/2021 and 18232540A
- exp 08/2021
Distribution
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