CLASS II Drug recall · Reported 15 Jul 2015 · FDA Enforcement Report
Capecitabine Tablets, USP, 500 mg recalled by Mylan Pharmaceuticals
Mylan Pharmaceuticals is recalling Capecitabine Tablets, USP, 500 mg, distributed nationwide in the US. The recall was initiated on 30 Jun 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1217-2015
- FDA event ID
- 71566
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jun 2015
- FDA classified
- 8 Jul 2015
- Reported
- 15 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Cancer Medication
Timeline
| 30 Jun 2015 | Recall initiated by company | |
| 8 Jul 2015 | Classified by FDA | +8 days |
| 15 Jul 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Is Capecitabine Tablets, USP, 500 mg recalled?
Yes. Mylan Pharmaceuticals recalled Capecitabine Tablets, USP, 500 mg on 30 Jun 2015. The recall is Class II and its status is Terminated. Recall number D-1217-2015.
Why was it recalled?
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
Which lots are affected?
Lot #: 3053562, Exp 02/16
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mylan Pharmaceuticals
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
Other Capecitabine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Capecitabine tablets USP 500 mg, Cytotoxic Agent recalledCapecitabine | Teva North America | Potency & Assay | Nationwide |