CLASS I Drug recall · Reported 26 Jan 2022 · FDA Enforcement Report
Semglee (insulin glargine) injection/mL (U-100) Prefilled Pen recalled
Mylan Pharmaceuticals is recalling Semglee (insulin glargine) injection/mL (U-100) Prefilled Pen (, distributed nationwide in the US. The recall was initiated on 5 Jan 2022 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0462-2022
- FDA event ID
- 89357
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 5 Jan 2022
- FDA classified
- 28 Jan 2022
- Reported
- 26 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Diabetes Medication
Timeline
| 5 Jan 2022 | Recall initiated by company | |
| 26 Jan 2022 | Published in enforcement report | +21 days |
| 28 Jan 2022 | Classified by FDA | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA and Thailand.
Questions about this recall
Why was it recalled?
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Which lots are affected?
Batch # BF20003118, Exp. August 2022
Where was it sold?
Nationwide in the USA and Thailand.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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