CLASS II Drug recall · Reported 22 Jan 2025 · FDA Enforcement Report
glipiZIDE, Extended-Release Tablets, 2.5 mg ( blister cards) recalled
Amerisource Health Services is recalling glipiZIDE, Extended-Release Tablets, 2.5 mg ( blister cards), distributed nationwide in the US. The recall was initiated on 17 Dec 2024 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-0202-2025
- FDA event ID
- 96033
- Recalling firm
- Amerisource Health Services, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Dec 2024
- FDA classified
- 16 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Diabetes Medication
Timeline
| 17 Dec 2024 | Recall initiated by company | |
| 16 Jan 2025 | Classified by FDA | +30 days |
| 22 Jan 2025 | 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
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications:
Which lots are affected?
Lot # 1012910, Exp Date: 04/30/2025
Where was it sold?
Nationwide in the USA
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.
More recalls from Amerisource Health Services
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |
Other Glipizide recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | GlipiZIDE Extended-Release Tablets, 2.5 mg recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | GlipiZIDE Extended-release Tablets, 2.5 mg (3 recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | GlipiZIDE Extended-release tablets, 2.5 mg carton recalled | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | glipiZIDE Extended-Release Tablets, 5 mg recalled | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Glipizide 2.5 mg ER Tablets recalled by RemedyRepack | RemedyRepack | Potency & Assay | FL |