CLASS II Drug recall · Reported 22 Feb 2017 · FDA Enforcement Report
Glipizide extended-release tablets, 5mg recalled by Actavis
Actavis is recalling Glipizide extended-release tablets, 5mg, distributed nationwide in the US. The recall was initiated on 30 Jan 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-0476-2017
- FDA event ID
- 76406
- Recalling firm
- Actavis, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jan 2017
- FDA classified
- 15 Feb 2017
- Reported
- 22 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Diabetes Medication
Timeline
| 30 Jan 2017 | Recall initiated by company | |
| 15 Feb 2017 | Classified by FDA | +16 days |
| 22 Feb 2017 | Published in enforcement report | +7 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. Above out of specification for dissolution rate observed at 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 extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4
Where it was distributed
Nationwide in US
Questions about this recall
Is Glipizide extended-release tablets, 5mg recalled?
Yes. Actavis recalled Glipizide extended-release tablets, 5mg on 30 Jan 2017. The recall is Class II and its status is Terminated. Recall number D-0476-2017.
Why was it recalled?
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Which lots are affected?
Lot #: 3134201, 3134202, Exp. 06/30/17; 3134319, Exp. 05/31/17; 3135246, Exp. 07/31/17; 3135247, 3136781, Exp. 08/31/17; 3136782, Exp. 09/30/17; 3136903, 3136904, Exp.10/31/17; 3138250, Exp. 07/31/17; 3138968, Exp. 08/31/17; 3140000, Exp. 09/30/17
Where was it sold?
Nationwide in US
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 21 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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| Drug | CLASS III | Levofloxacin Ophthalmic Solution, 5%, Sterile recalled by Actavis | Actavis | Sterility | Nationwide |
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| 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 |
| Drug | CLASS II | Glipizide 5 mg Extended-release tablets recalled by Actavis | Actavis | Potency & Assay | Nationwide |
Other Glipizide recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | GlipiZIDE Extended-Release Tablets, 5 mg recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | GlipiZIDE Extended-release Tablets, 5 mg (3 x recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg recalled | Teva Pharmaceuticals U | Potency & Assay | 6 states |
| Drug | CLASS II | GlipiZIDE Extended-release tablets, 5 mg carton recalled | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | glipiZIDE Extended-Release Tablets, 5 mg recalled | Mylan Pharmaceuticals | Other | Nationwide |