Mylan recalls insulin glargine vials with missing labels to prevent medication errors. This insulin product (100 units/mL, 10mL vial) was manufactured with a missing label that could lead to incorrect dosing.
“Mylan Insulin Glargine Vial Missing Label - Recall Notice.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34968-mylan-insulin-glargine-vial-missing-label-recall-notice. Based on FDA recall #D-0845-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0845-2022%22&limit=1).
Mylan Pharmaceuticals Inc. recalled Insulin Glargine Injection vials due to missing labels on the packaging, according to the FDA on April 12, 2022. The recall affects 89,665 units distributed nationwide.
The hazard is missing labeling on the vial, which could lead to medication errors. The FDA classified this as a Class I recall.
Context
GovInfoNow's records show Mylan Pharmaceuticals Inc. has issued 54 other recalls since June 28, 2012. Recent Mylan recalls include Mycophenolate Mofetil Injections on Aug. 26, 2026, and Prasugrel Tablets on Aug. 17, 2026. Other recent recalls of similar products include American Regent Levocarnitine Injection (April 16, 2026), CAPS TPN Bag (Dec. 27, 2025), and Baxter Healthcare MYXREDLIN Insulin (Aug. 6, 2026).
How to tell if you have this one
Check for insulin glargine vials (100 units/mL, 10mL) with missing labels. The vials were manufactured with lot number BF21002800 and expire 8/2023.
Brand
Mylan
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Label
Inspect the vial for a missing label that identifies the insulin product.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA 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 18 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0845-2022 (April 12, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0845-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.