Mylan Recalls Capecitabine Tablets Due to Dissolution Failures
Mylan Pharmaceuticals is recalling 1,068 bottles of Capecitabine Tablets, 500 mg, because the product failed to meet dissolution specifications.
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, and the hazard involves a quality specification failure (dissolution) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 1,068 bottles of Capecitabine Tablets, USP, 500 mg, 120-count bottles. The affected product is identified by Lot # 3053562 and an expiration date of 02/16. The recall is classified as Class II by the FDA.
The recall was initiated because the product obtained low out-of-specification (OOS) results for dissolution at the nine-month stability point. This indicates that the tablets may not dissolve at the required rate, which could affect the delivery of the medication.
The affected product was distributed nationwide. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for a replacement or further instructions.
The recalled product
- Product
- Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6.
- Manufacturer
- Mylan Pharmaceuticals Inc
- Category
- Drug — Antineoplastic
- Hazard
- Affected units
- 1,068
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 (2)
- Lot #: 3053562
- Exp 02/16
Distribution
Distributed nationwide across the United States.
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