Mylan Recalls Capecitabine Tablets Due to Dissolution Failure
Mylan Pharmaceuticals recalls one lot of 500 mg Capecitabine tablets because they failed dissolution specifications. Check your bottle's lot number.
Use caution until it’s fixed
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
Contact the company
What happened, in plain English
Mylan Pharmaceuticals Inc. is recalling a specific lot of Capecitabine Tablets, USP, 500 mg in 120-count bottles. The recall was initiated because the tablets produced low out-of-specification results for dissolution at the nine-month stability point. This means the drug may not dissolve properly as intended. Read more at govinfonow.com/recall/44112-mylan-pharmaceuticals-inc-recalls-capecitabine-tablets-usp-500-mg-120.
Source Summary by GovInfoNow · govinfonow.com/recall/44112-mylan-pharmaceuticals-inc-recalls-capecitabine-tablets-usp-500-mg-120 · Updated October 12, 2026 · FDA enforcement record: FDA #D-1217-2015
Cite this page
“Mylan Recalls Capecitabine Tablets Due to Dissolution Failure.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44112-mylan-pharmaceuticals-inc-recalls-capecitabine-tablets-usp-500-mg-120. Based on FDA recall #D-1217-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1217-2015%22&limit=1).
Why it’s dangerous
The tablets failed to meet dissolution specifications during stability testing. If the drug does not dissolve correctly in the body, it may not be absorbed properly, potentially leading to reduced effectiveness of the treatment.
Who’s affected
Patients currently taking Capecitabine prescribed by a healthcare provider are affected. The risk depends on whether the specific bottle has the recalled lot number, as improper dissolution could affect how the medication works.
How to tell if you have this one
Check your bottle for NDC 0378-2512-78 and UPC 3 0378-2512-78 6. The recalled lot number is 3053562 with an expiration date of 02/16. These bottles were distributed nationwide.
- Brand
Mylan Pharmaceuticals- Product
Mylan Pharmaceuticals Inc recalls Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC- Category
Drug
What to do — step by step
Check your medication
Verify if your bottle matches NDC 0378-2512-78, UPC 3 0378-2512-78 6, and lot number 3053562.
Contact your pharmacist
If you have the recalled product, speak with your pharmacist or healthcare provider about next steps.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1217-2015 (June 30, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1217-2015 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.