Food, drugs, devices › Mylan Pharmaceuticals Inc
Drug recall: Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside
Mylan Pharmaceuticals Inc (Morgantown, WV) initiated this drug recall on 12 Apr 2022; FDA lists 1 product record under event 89970, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 18% of the 325 drug enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 18 Oct 2023. Initiation: voluntary: firm initiated. Mylan Pharmaceuticals Inc has 55 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Mylan Pharmaceuticals Inc, Morgantown, WV.
Reason for recall
"Labeling: Missing label on the vial"
Distribution
"USA nationwide."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0845-2022 | Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Manufactured for: Mylan Specialty L.P., Morgantown, WV 26505, NDC 49502-393-80 | 89,665 vials | Class I | Terminated | 4 May 2022 |
Context
Other enforcement events for Mylan Pharmaceuticals Inc
All 55 events for Mylan Pharmaceuticals Inc
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Labeling: Missing label on the vial"
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "USA nationwide."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Oct 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.