CLASS II ONGOING Drug recall · Reported 27 May 2026 · FDA Enforcement Report
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg recalled
IntegraDose Compounding Services is recalling fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/ in Sterile Water, IntegraDose, distributed nationwide in the US. The recall was initiated on 12 May 2026 and the FDA has classified it as Class II.
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-0548-2026
- FDA event ID
- 98991
- Recalling firm
- IntegraDose Compounding Services, Shoreview, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 May 2026
- FDA classified
- 21 May 2026
- Reported
- 27 May 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 12 May 2026 | Recall initiated by company | |
| 21 May 2026 | Classified by FDA | +9 days |
| 27 May 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot#: 20260310FEN-1, Exp. Date: 09/06/2026
Where was it sold?
Nationwide.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from IntegraDose Compounding Services
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vasopressin in 0.9% Sodium Chloride, syringe recalled | IntegraDose Compounding Services | Potency & Assay | Nationwide |
| Drug | CLASS I | Oxytocin in 0.9% Sodium Chloride for intravenous use recalled | IntegraDose Compounding Services | Potency & Assay | Nationwide |
| Drug | CLASS II | fentaNYL Citrate 2,500 mcg/ in Sterile Water CADD recalled | IntegraDose Compounding Services | Sterility | Nationwide |
| Drug | CLASS II | Vasopressin in 0.9% Sodium Chloride Sterile Syringe recalled | IntegraDose Compounding Services | Potency & Assay | MN |
| Drug | CLASS II | Vasopressin in 0.9% Sodium Chloride per syringe recalled | IntegraDose Compounding Services | Potency & Assay | MN |
Other Fentanyl recalls
All 248| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | fentaNYL Citrate, 1,000 mcg recalled by OurPharma | OurPharma | Other | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution recalled by Wells Pharma of Houston | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, CII recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, Cii recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate injectable Solution recalled by Wells Pharma of Houston | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |