Sandoz Recalls Candesartan Cilexetil 16 mg Tablets Due to Impurities
Sandoz recalls specific lots of Candesartan Cilexetil Tablets, 16 mg, due to failed impurity specifications. Check your NDC and lot numbers.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications; 9 month stability timepoint
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What happened, in plain English
Sandoz Inc is recalling specific bottles of Candesartan Cilexetil Tablets, 16 mg, because they failed impurity and degradation specifications at the 9-month stability timepoint. The recall affects both 30-count and 90-count Rx bottles distributed nationwide. No remedy or action steps are currently stated in the record. Read more at govinfonow.com/recall/43301-sandoz-recalls-candesartan-cilexetil-16-mg-tablets-due-to-impurities.
Source Summary by GovInfoNow · govinfonow.com/recall/43301-sandoz-recalls-candesartan-cilexetil-16-mg-tablets-due-to-impurities · Updated October 11, 2026 · FDA enforcement record: FDA #D-0659-2016
Cite this page
“Sandoz Recalls Candesartan Cilexetil 16 mg Tablets Due to Impurities.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43301-sandoz-recalls-candesartan-cilexetil-16-mg-tablets-due-to-impurities. Based on FDA recall #D-0659-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0659-2016%22&limit=1).
Why it’s dangerous
The recalled tablets failed to meet specifications for impurities and degradation after 9 months of stability testing. This means the chemical composition of the drug may have changed over time, potentially affecting its safety or efficacy, though the record does not specify what those specific impurities are or their direct health impact.
Who’s affected
Patients who have been prescribed Candesartan Cilexetil Tablets, 16 mg, by a healthcare provider and purchased them from pharmacies across the United States. Individuals holding specific lot numbers listed in the recall notice are directly affected.
How to tell if you have this one
Look for bottles labeled 'Candesartan Cilexetil Tablets, 16 mg' manufactured by Mylan Laboratories Limited in India for Sandoz Inc. Check for NDC numbers 00781-5938-31 (30 count) or 00781-5938-92 (90 count). Verify if your bottle's lot number and expiration date match the specific lots listed in the record.
- Brand
Sandoz- Category
Drug
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 III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Which lot numbers are recalled?
Recalled lots include 3022288, 3025988, 3025989, 3030459, 3030460, 3032087, 3032088, 3034506, 3035952, 3035953 for the 30-count bottles, and 3022287, 3025990, 3030458, 3032086, 3035954 for the 90-count bottles.
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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-0659-2016 (December 31, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0659-2016 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.