Teva Recalls Capecitabine 500mg Tablets Due to Dissolution Failure
Teva North America recalls specific lots of Capecitabine tablets USP 500 mg because they failed dissolution specifications, potentially affecting drug efficacy.
Use caution until it’s fixed
Failed Dissolution Specifications: low test results at the 18 month time-point
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What happened, in plain English
Teva North America is recalling a specific lot of Capecitabine tablets USP 500 mg because the product failed to meet dissolution specifications at the 18-month time point. This means the medication may not release or absorb properly in the body, which could reduce its effectiveness for patients relying on it. The recall affects 1,895 bottles distributed nationwide. Read more at govinfonow.com/recall/43317-teva-recalls-capecitabine-500mg-tablets-due-to-dissolution-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/43317-teva-recalls-capecitabine-500mg-tablets-due-to-dissolution-failure · Updated October 11, 2026 · FDA enforcement record: FDA #D-0732-2016
Cite this page
“Teva Recalls Capecitabine 500mg Tablets Due to Dissolution Failure.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43317-teva-recalls-capecitabine-500mg-tablets-due-to-dissolution-failure. Based on FDA recall #D-0732-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0732-2016%22&limit=1).
Why it’s dangerous
The hazard is that the tablets failed dissolution specifications, meaning they did not break down or release the drug correctly during testing at the 18-month mark. If a patient takes these tablets, the medication might not be absorbed effectively, potentially leading to inadequate treatment of their condition.
Who’s affected
Patients who have been prescribed Capecitabine tablets USP 500 mg and possess the specific lot number listed in the record are affected. Individuals taking this medication for cancer treatment are most at risk of receiving a product that may not work as intended.
How to tell if you have this one
Check your bottle for NDC 0093-7474-89 and Lot # 3A404012V with an expiration date of 4/2016. The product is Capecitabine tablets USP 500 mg, sold in bottles of 120 tablets, manufactured by Teva Czech Industries sro for Teva Pharmaceuticals USA.
- Brand
Teva- Category
Drug
What to do — step by step
Check Your Medication
Verify if your bottle matches NDC 0093-7474-89 and Lot # 3A404012V with an expiration date of 4/2016.
Contact Your Pharmacist
Speak with your healthcare provider or pharmacist immediately to discuss alternative treatment options if you have this specific lot.
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 13 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-0732-2016 (December 21, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0732-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.