CLASS I Drug recall · Reported 16 Nov 2022 · FDA Enforcement Report
Octreotide Acetate Injection 500 mcg/mL recalled by Viatris
Viatris is recalling Octreotide Acetate Injection 500 mcg/mL, mL Single-Dose Unit-of-Use Syringes, For, distributed nationwide in the US. The recall was initiated on 7 Oct 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-0058-2023
- FDA event ID
- 90974
- Recalling firm
- Viatris, Canonsburg, PA
- Brand
- Octreotide Acetate
- Manufacturer
- Mylan Institutional LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 7 Oct 2022
- FDA classified
- 8 Nov 2022
- Reported
- 16 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 7 Oct 2022 | Recall initiated by company | |
| 8 Nov 2022 | Classified by FDA | +32 days |
| 16 Nov 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
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Product as listed by the FDA
Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., Made in Italy, NDC: 67457-246-00 (syringe), 67457-246-01 (carton).
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Octreotide Acetate Injection 500 mcg/mL, mL Single-Dose Unit-of-Use Syringes, For recalled?
Yes. Viatris recalled Octreotide Acetate Injection 500 mcg/mL, mL Single-Dose Unit-of-Use Syringes, For on 7 Oct 2022. The recall is Class I and its status is Terminated. Recall number D-0058-2023.
Why was it recalled?
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Which lots are affected?
Lot #: AJ21002, Exp. 03/2024
Where was it sold?
Nationwide in the USA
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 21 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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Other Octreotide recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Octreotide Acetate Injection 50 mcg/mL single-dose vial recalled | Teva Pharmaceuticals U | Sterility | Nationwide |