Sandoz Pioglitazone-Glimepiride Tablets Recall: Failed Dissolution Specifications
Sandoz recalls 30 mg/4 mg Pioglitazone-Glimepiride tablets with failed dissolution specs. Rx-only bottles manufactured by Lek Pharmaceuticals in Slovenia. Check NDC 0781-5635-31, Lot FY3669 (exp 11/2017).
Lower-risk recall
Failed Dissolution Specifications
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What happened, in plain English
Sandoz is recalling specific Pioglitazone and Glimepiride tablets that failed dissolution tests. This means the medication may not work properly as intended, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/41969-sandoz-pioglitazone-glimepiride-tablets-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/41969-sandoz-pioglitazone-glimepiride-tablets-recall-failed-dissolution-specifications · Updated October 8, 2026 · FDA enforcement record: FDA #D-0515-2017
Cite this page
“Sandoz Pioglitazone-Glimepiride Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41969-sandoz-pioglitazone-glimepiride-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-0515-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0515-2017%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications, meaning they may not release the active ingredients properly in the body. This could lead to inconsistent medication levels and reduced effectiveness for treating diabetes or metabolic conditions.
Who’s affected
Prescription drug users who have the specific 30-count bottles with NDC 0781-5635-31 and Lot FY3669 (expiring 11/2017). Patients on diabetes or metabolic conditions are most at risk if the medication isn't effective.
How to tell if you have this one
Check for the 30 mg/4 mg Pioglitazone-Glimepiride tablets in 30-count bottles labeled Rx only. Look for NDC code 0781-5635-31 and lot number FY3669 with an expiration date of 11/2017.
- Brand
Sandoz- Category
Drug
What to do — step by step
Check Your Medication
Look for the NDC code 0781-5635-31 and lot number FY3669 on the bottle label.
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 8 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.
Questions people ask
Do I need to stop using these tablets?
No, the recall does not require stopping use immediately. However, you should check if you have the specific recalled bottles and contact your doctor if you're concerned about effectiveness.
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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-0515-2017 (February 10, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0515-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.