Sandoz Recalls Pioglitazone and Glimepiride Tablets Due to Dissolution Failure
Sandoz Inc is recalling specific lots of Pioglitazone and Glimepiride Tablets because they failed to meet dissolution specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that may cause temporary or medically reversible health consequences. The failure to meet dissolution specifications is a quality defect that may affect efficacy but does not present an immediate risk of serious injury or death, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Sandoz Inc is recalling Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles. The affected product is identified by NDC 0781-5635-31 and was manufactured by Lek Pharmaceuticals d.d. in Slovenia. The specific lot involved is FY3669, with an expiration date of 11/2017.
The recall was initiated because the tablets failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the medication breaks down properly in the body to release the active ingredients. When this specification is not met, the medication may not work as intended.
The product was distributed nationwide. Patients and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the medication should be returned to the pharmacy or Sandoz Inc for replacement or refund. Consumers should not take the recalled medication and should consult their healthcare provider for alternative treatment options.
The recalled product
- Product
- 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
- Manufacturer
- Sandoz Inc
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot FY3669 with expiry 11/2017
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Sandoz Inc
See all →- LowFocalin XR 5mg capsules carry incorrect or missing lot and expiry
FDA (Drugs) · 2026-06-24
- ModerateCyclophosphamide injection vials recalled after a transportation temperature excursion
FDA (Drugs) · 2025-09-24
- ModerateCiprofloxacin and dexamethasone otic suspension recalled following temperature abuse
FDA (Drugs) · 2025-09-17
- SevereSandoz cefazolin cartons contained vials labeled as penicillin G potassium
FDA (Drugs) · 2025-07-09
- SevereBuffered penicillin G potassium vials may actually contain cefazolin for injection
FDA (Drugs) · 2025-07-09
Same hazard · dissolution failure
See all →- ModerateApotex Recalls Paroxetine Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateAjanta Pharma Recalls Ranolazine Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateMylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures
FDA (Drugs) · 2026-09-09
- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
Similar recalls
- ModerateSandoz Recalls Nadolol Tablets Due to Failed Dissolution Test
FDA (Drugs) · 2017-01-04
- LowSandoz Recalls Orphenadrine Citrate Tablets for Dissolution Failures
FDA (Drugs) · 2014-07-30
- ModerateActavis Recalls Glipizide Extended-Release Tablets Due to Dissolution Failure
FDA (Drugs) · 2017-02-22
- ModerateZydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2017-08-09
- ModerateZydus Recalls Lansoprazole Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2020-12-23
- LowGreenstone Recalls Glipizide XL Tablets Due to Dissolution Failure
FDA (Drugs) · 2014-02-12