Mylan Recalls Paliperidone Extended-Release Tablets Due to Dissolution Failures
Mylan Pharmaceuticals is recalling 2,928 bottles of Paliperidone Extended-Release Tablets, 1.5 mg, because they failed dissolution specifications at a three-month stability time point.
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: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score when no specific injuries or hospitalizations are reported in the source text, and the defect is a stability/dissolution failure rather than a high-risk pathogen or structural defect.
Plain-English summary
Mylan Pharmaceuticals, Inc. is voluntarily recalling 2,928 bottles of Paliperidone Extended-Release Tablets, 1.5 mg, 30-count bottles. The product is identified by NDC 0378-3978-93, Lot 2005441, and an expiration date of 01/2017. The recall is being conducted because the tablets failed to meet dissolution specifications at a three-month stability time point.
The affected product was distributed nationwide. Paliperidone Extended-Release Tablets are prescription-only medications. The recall is classified as Class II by the U.S. Food and Drug Administration, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers who have this specific lot of Paliperidone Extended-Release Tablets should stop using them and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall is limited to the specific lot and NDC number listed above.
The recalled product
- Product
- Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Antipsychotic
- Affected units
- 2,928
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)
- Lot: 2005441
- 01/2017
- Code: 0378-3978-93
Distribution
Distributed nationwide across the United States.
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