CLASS I Drug recall · Reported 3 Aug 2022 · FDA Enforcement Report
Insulin Glargine (Insulin glargine-yfgn) Injection/mL recalled
Mylan Pharmaceuticals is recalling Insulin Glargine (Insulin glargine-yfgn) Injection/mL (U-100) prefilled pens (, distributed nationwide in the US. The recall was initiated on 5 Jul 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-1292-2022
- FDA event ID
- 90545
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 5 Jul 2022
- FDA classified
- 26 Jul 2022
- Reported
- 3 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
- Drug class
- Diabetes Medication
Timeline
| 5 Jul 2022 | Recall initiated by company | |
| 26 Jul 2022 | Classified by FDA | +21 days |
| 3 Aug 2022 | Published in enforcement report | +8 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 prefilled pens.
Product as listed by the FDA
Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specialty L.P., Morgantown, WV
Where it was distributed
Product was distributed nationwide within the United States
Questions about this recall
Why was it recalled?
Labeling: Missing label: Label missing from some prefilled pens.
Which lots are affected?
Lot #: BF21002895, Exp. Date Aug 2023
Where was it sold?
Product was distributed nationwide within the United States
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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|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
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| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
Other Insulin Glargine (insulin Glargine-yfgn recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Insulin Glargine (insulin glargine-yfgn) Injection/mL (U-100) recalled | Mylan Pharmaceuticals | Labeling Errors | Nationwide |