FDA recalls glipiZIDE Extended-Release Tablets for failed dissolution specifications
Amerisource Health Services LLC is recalling glipiZIDE Extended-Release Tablets, 2.5 mg, due to failed dissolution specifications. Patients should contact their pharmacist or healthcare provider.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The recall addresses a risk-of-harm product—a medication with failed dissolution specifications—where actual injury has not yet been reported, meeting the High severity criterion.
Plain-English summary
Amerisource Health Services LLC is recalling glipiZIDE Extended-Release Tablets, 2.5 mg, due to failed dissolution specifications. Lot 1012910 with an expiration date of April 30, 2025, was distributed nationwide.
Failed dissolution specifications mean the tablets may not dissolve properly in the body as intended. This manufacturing defect could affect how the medication is absorbed and used by the patient.
Patients who have received this medication should contact their pharmacist or healthcare provider to discuss alternative treatments. Healthcare providers and pharmacists should quarantine stock of the affected lot immediately.
The recalled product
- Product
- glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Extended-Release Tablet
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 (2)
- Lot # 1012910
- Exp Date: 04/30/2025
Distribution
Distributed nationwide across the United States.
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