Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Semglee (insulin glargine) injection Recalled by Mylan Pharmaceuticals Inc Due to Labeling: Missing Label: label missing from some Semglee...

Date: January 5, 2022
Company: Mylan Pharmaceuticals Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Mylan Pharmaceuticals Inc directly.

Affected Products

Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505.

Quantity: 73,175 prefilled pens

Why Was This Recalled?

Labeling: Missing Label: label missing from some Semglee prefilled pens.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mylan Pharmaceuticals Inc

Mylan Pharmaceuticals Inc has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report