CLASS II Drug recall · Reported 15 Mar 2017 · FDA Enforcement Report
Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg recalled by Sandoz
Sandoz is recalling Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, distributed nationwide in the US. The recall was initiated on 10 Feb 2017 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-0515-2017
- FDA event ID
- 76515
- Recalling firm
- Sandoz, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Feb 2017
- FDA classified
- 9 Mar 2017
- Reported
- 15 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Diabetes Medication
Timeline
| 10 Feb 2017 | Recall initiated by company | |
| 9 Mar 2017 | Classified by FDA | +27 days |
| 15 Mar 2017 | Published in enforcement report | +6 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
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
Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manufactured by Lek Pharmaceuticals d.d., Verovskova Ulica 57, Ljubljana, - SI-1526, Slovenia --- NDC 0781-5635-31
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot FY3669 with expiry 11/2017
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.
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Other Pioglitazone recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pioglitazone Tablets USP, 45 mg recalled by Aurobindo Pharma USAPioglitazone | Aurobindo Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg recalled | Macleods Pharma Usa | Potency & Assay | Nationwide |
| Drug | CLASS II | Pioglitazone Hydrochloride Tablets USP 15 mg recalledPioglitazone | Macleods Pharma Usa | Potency & Assay | NJ |
| Drug | CLASS II | Pioglitazone, Tablet, 15 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Pioglitazone HCL, Tablet, 15 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |