CLASS II Drug recall · Reported 24 Aug 2016 · FDA Enforcement Report
Glipizide 2.5 mg Extended-release tablets recalled by Actavis
Actavis is recalling Glipizide 2.5 mg Extended-release tablets, distributed nationwide in the US. The recall was initiated on 30 Jun 2016 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-1457-2016
- FDA event ID
- 74702
- Recalling firm
- Actavis, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jun 2016
- FDA classified
- 15 Aug 2016
- Reported
- 24 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Diabetes Medication
Timeline
| 30 Jun 2016 | Recall initiated by company | |
| 15 Aug 2016 | Classified by FDA | +46 days |
| 24 Aug 2016 | Published in enforcement report | +9 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: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
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 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Which lots are affected?
Lot # 3132593, 3132594, 3134420, 3134421,3134422, Exp. 02/17
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.
More recalls from Actavis
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Levofloxacin Ophthalmic Solution, 0.5%, Sterile recalled by Actavis | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS II | Glipizide extended-release tablets, 2.5mg recalled by Actavis | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS III | Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / Vials recalled | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS III | Hydrocortisone and acetic acid otic solution recalled by Actavis | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS III | Acetasol HC (hydrocortisone and acetic acid otic solution USP) recalled | Actavis | Potency & Assay | Nationwide |
Other Glipizide recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | glipiZIDE, Extended-Release Tablets, 2.5 mg ( blister cards) recalled | Amerisource Health Services | Potency & Assay | Nationwide |
| 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 |