Actavis Recalls Glipizide ER Tablets Due to Dissolution Failure
Actavis recalls 167,152 bottles of Glipizide 2.5 mg ER tablets due to failed dissolution specifications. Check your lot numbers and expiration date.
Use caution until it’s fixed
Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
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What happened, in plain English
Actavis Inc is recalling Glipizide 2.5 mg Extended-release tablets because they failed to meet dissolution specifications at the 10-hour testing point. This means the medication may not release properly, potentially affecting how well it works for patients. The recall affects 167,152 bottles distributed nationwide. Read more at govinfonow.com/recall/42563-actavis-recalls-glipizide-er-tablets-due-to-dissolution-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/42563-actavis-recalls-glipizide-er-tablets-due-to-dissolution-failure · Updated October 9, 2026 · FDA enforcement record: FDA #D-1457-2016
Cite this page
“Actavis Recalls Glipizide ER Tablets Due to Dissolution Failure.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42563-actavis-recalls-glipizide-er-tablets-due-to-dissolution-failure. Based on FDA recall #D-1457-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1457-2016%22&limit=1).
Why it’s dangerous
The tablets exceeded dissolution specification rates for the 10-hour testing point, meaning the drug may not release into the body as intended over time. This could result in inconsistent blood sugar control or reduced effectiveness of the treatment.
Who’s affected
Patients who have been prescribed Glipizide 2.5 mg Extended-release tablets manufactured by Patheon Pharmaceuticals Inc and purchased from pharmacies nationwide are affected. Individuals relying on this specific dosage for diabetes management are most at risk of receiving ineffective medication.
How to tell if you have this one
Check your bottle for NDC 00591-0900-30 and look for lot numbers 3132593, 3132594, 3134420, 3134421, or 3134422. The expiration date on the bottle is 02/17. The product is a 30-count bottle of Rx-only tablets manufactured by Patheon Pharmaceuticals Inc in Cincinnati, OH.
- Brand
Actavis- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your Glipizide 2.5 mg ER tablets match the recalled NDC and lot numbers listed above.
Contact Your Pharmacist
If you have the affected product, contact your pharmacy or healthcare provider for instructions on replacement or disposal.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1457-2016 (June 30, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1457-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.