Mylan Glipizide 5mg Tablets Recall: Foreign Tablets May Be Present
Mylan recalls 5mg Glipizide Extended-Release Tablets due to possible presence of 10mg tablets in some bottles. This could lead to incorrect dosing if taken without knowing.
Lower-risk recall
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
Contact the company
What happened, in plain English
Mylan is recalling 5mg Glipizide Extended-Release Tablets because some bottles may contain 10mg tablets instead. This could cause incorrect dosing if a person takes the tablets without realizing the difference in strength. Read more at govinfonow.com/recall/42073-mylan-glipizide-5mg-tablets-recall-foreign-tablets-may-be-present.
Source Summary by GovInfoNow · govinfonow.com/recall/42073-mylan-glipizide-5mg-tablets-recall-foreign-tablets-may-be-present · Updated October 8, 2026 · FDA enforcement record: FDA #D-0491-2017
Cite this page
“Mylan Glipizide 5mg Tablets Recall: Foreign Tablets May Be Present.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42073-mylan-glipizide-5mg-tablets-recall-foreign-tablets-may-be-present. Based on FDA recall #D-0491-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0491-2017%22&limit=1).
Why it’s dangerous
The recalled bottles may contain 10mg tablets instead of the labeled 5mg tablets. If someone takes the tablets without knowing the actual strength, they could receive a higher dose than intended, leading to potential side effects.
Who’s affected
People prescribed Glipizide 5mg tablets by a doctor who own or use the recalled product. Those with diabetes are most at risk if they take the wrong tablet strength.
How to tell if you have this one
Check for the product name 'Glipizide Extended-Release Tablets, 5 mg, 1000 count bottles' with NDC code 0378-0342-10 and batch number 3074621 from June 2018.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 0378-0342-10 and batch number 3074621 on the bottle label.
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 6 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-0491-2017 (January 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0491-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.