Sandoz Recalls Candesartan Cilexetil 16 mg Tablets Due to Impurity Issues
Sandoz recalls specific lots of 16 mg candesartan cilexetil tablets due to failed impurity specifications. Check your bottle's lot number and expiration date.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
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What happened, in plain English
Sandoz Inc. is recalling one lot of candesartan cilexetil, 16 mg tablets in 90-count bottles because they failed impurity specifications during stability testing. The recall affects NDC 0781-5938-92, Lot #3007330, with an expiration date of November 2014. This issue was identified through laboratory analysis rather than reported adverse events. Read more at govinfonow.com/recall/45741-sandoz-inc-recalls-candesartan-cilexetil-tablets-16-mg-90-count.
Source Summary by GovInfoNow · govinfonow.com/recall/45741-sandoz-inc-recalls-candesartan-cilexetil-tablets-16-mg-90-count · Updated October 12, 2026 · FDA enforcement record: FDA #D-0288-2015
Cite this page
“Sandoz Recalls Candesartan Cilexetil 16 mg Tablets Due to Impurity Issues.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/45741-sandoz-inc-recalls-candesartan-cilexetil-tablets-16-mg-90-count. Based on FDA recall #D-0288-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0288-2015%22&limit=1).
Why it’s dangerous
The recalled tablets failed to meet specifications for ketone cilexetil impurity and total impurities at the 18-month stability time point. While the record does not specify immediate physical symptoms, out-of-specification impurities can potentially affect the drug's safety or efficacy over time.
Who’s affected
Patients currently taking candesartan cilexetil 16 mg tablets who purchased the specific recalled lot from nationwide distribution before October 2014. Individuals with this medication in their possession should verify if it matches the recalled details.
How to tell if you have this one
Check your medication bottle for NDC 0781-5938-92 and Lot #3007330. The expiration date on the bottle should be November 2014 (Exp 11/2014). The product is manufactured by Mylan Laboratories Limited in Hyderabad, India, for Sandoz Inc.
- Brand
Sandoz- Category
Drug
What to do — step by step
Check Your Medication
Verify if your bottle matches NDC 0781-5938-92 and Lot #3007330 with an expiration date of November 2014.
Contact Your Pharmacist
If you have the recalled product, contact your pharmacist or healthcare provider for instructions on replacement or disposal.
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 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-0288-2015 (October 2, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0288-2015 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.