Recall archive / FDA company announcement

Semglee: Insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens — FDA announcement Jan 19, 2022

Reported terminated

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Jan 19, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens
Reason: Missing Label
Classification: Not supplied
Recalling firm: Mylan Pharmaceutical Inc.
Quantity: Not supplied
Agency-reported status: Terminated in FDA listing
Source record identifier: bbf8ff92f8be4ec9

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	PITTSBURGH – Jan. 18, 2022 – Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens, which are packaged in a labelled carton of five (5) pens. The product is being recalled due to the potential for the label to be missing on some prefilled pens within a labelled carton for this particular batch.; This batch was manufactured by Biocon Sdn Bhd. and distributed by Mylan Specialty L.P. in the U.S. between May 11, 2021 and November 11, 2021. The recalled lot is as follows:; The company has initiated the recall of batch BF20003118 and notified its distributors and retailers by letter and is arranging for return of all recalled products. Following are actions for wholesalers, retailers and consumers:; Wholesaler: Immediately examine your inventory, quarantine, and discontinue distribution of this lot. In addition, if you have further distributed the product, please identify your retail level customers and provide a list of customers via Microsoft excel file to [email protected] within 10 business days. Stericycle will notify your retail level customers that received the affected batch.; Retailer: Immediately examine your inventory, quarantine, and discontinue distribution of this batch.; NDC # \| Name and Strength \| Size \| Batch# \| Expiry; 49502-196-75 \| Semglee® (insulin glargine injection), 100 units/mL (U-100) \| 3mL Prefilled Pen \| BF20003118 \| August 2022

Label field

Details supplied by the agency

Lot, code or applicability

PITTSBURGH – Jan. 18, 2022 – Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens, which are packaged in a labelled carton of five (5) pens. The product is being recalled due to the potential for the label to be missing on some prefilled pens within a labelled carton for this particular batch.; This batch was manufactured by Biocon Sdn Bhd. and distributed by Mylan Specialty L.P. in the U.S. between May 11, 2021 and November 11, 2021. The recalled lot is as follows:; The company has initiated the recall of batch BF20003118 and notified its distributors and retailers by letter and is arranging for return of all recalled products. Following are actions for wholesalers, retailers and consumers:; Wholesaler: Immediately examine your inventory, quarantine, and discontinue distribution of this lot. In addition, if you have further distributed the product, please identify your retail level customers and provide a list of customers via Microsoft excel file to [email protected] within 10 business days. Stericycle will notify your retail level customers that received the affected batch.; Retailer: Immediately examine your inventory, quarantine, and discontinue distribution of this batch.; NDC # | Name and Strength | Size | Batch# | Expiry; 49502-196-75 | Semglee® (insulin glargine injection), 100 units/mL (U-100) | 3mL Prefilled Pen | BF20003118 | August 2022

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
NDC #	Name and Strength	Size	Batch#	Expiry
49502-196-75	Semglee® (insulin glargine injection), 100 units/mL (U-100)	3mL Prefilled Pen	BF20003118	August 2022

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date: Jan 19, 2022
Company announcement date: Jan 18, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.