CLASS II Drug recall · Reported 9 Mar 2016 · FDA Enforcement Report
Capecitabine tablets USP 500 mg, Cytotoxic Agent recalled
Teva North America is recalling Capecitabine tablets USP 500 mg, Cytotoxic Agent, distributed nationwide in the US. The recall was initiated on 21 Dec 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-0732-2016
- FDA event ID
- 72912
- Recalling firm
- Teva North America, Horsham, PA
- Brand
- Capecitabine
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Dec 2015
- FDA classified
- 1 Mar 2016
- Reported
- 9 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Cancer Medication
Timeline
| 21 Dec 2015 | Recall initiated by company | |
| 1 Mar 2016 | Classified by FDA | +71 days |
| 9 Mar 2016 | Published in enforcement report | +8 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 test results at the 18 month time-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, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: low test results at the 18 month time-point
Which lots are affected?
Lot # 3A404012V, Exp. 4/2016
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 26 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 Teva North America
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Claravis (isotretinoin capsules USP), 10mg recalled | Teva North America | Potency & Assay | Nationwide |
| Drug | CLASS II | Ondansetron Injection USP 40 mg/ (2 mg/mL) recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Eptifibatide Injection 75 mg/ (0.75 mg/mL) single use vial recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Linezolid Injection 600 mg recalled by Teva North America | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Argatroban Injection in 0.9% Sodium Chloride 250 mg/ (1 mg/mL) recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
Other Capecitabine recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Capecitabine 150 mg Tablet recalled by Kroger Specialty Pharmacy | Kroger Specialty Pharmacy | Other | 5 states |
| Drug | CLASS II | Capecitabine 500 mg Tablet recalled by Kroger Specialty Pharmacy | Kroger Specialty Pharmacy | Other | 5 states |
| Drug | CLASS II | Capecitabine Tablets, USP, 500 mg recalled by Mylan Pharmaceuticals | Mylan Pharmaceuticals | Potency & Assay | Nationwide |