CLASS II ONGOING Drug recall · Reported 10 Apr 2024 · FDA Enforcement Report
fentaNYL Citrate 2,500 mcg/ in Sterile Water CADD recalled
IntegraDose Compounding Services is recalling fentaNYL Citrate 2,500 mcg/ in Sterile Water CADD for Injection, IntegraDose Compounding, distributed nationwide in the US. The recall was initiated on 22 Mar 2024 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-0432-2024
- FDA event ID
- 94275
- Recalling firm
- IntegraDose Compounding Services, Minneapolis, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Mar 2024
- FDA classified
- 3 Apr 2024
- Reported
- 10 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 22 Mar 2024 | Recall initiated by company | |
| 3 Apr 2024 | Classified by FDA | +12 days |
| 10 Apr 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: leaking bags
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
Where it was distributed
Nationwide within the U.S
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: leaking bags
Which lots are affected?
Lot#: 20231020FEN-1, Exp: 04/17/2024
Where was it sold?
Nationwide within the U.S
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 8Other Fentanyl 2 recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | fentaNYL 2,500 mcg/ Injection (Concentration = 50 mcg/mL) recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL 2,500 mcg/ in 0.9 % Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL 2,500 mcg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride recalled | Cantrell Drug | Sterility | Nationwide |
| Drug | CLASS II | Fentanyl 2,000 mcg/ml Intrathecal Solution, Sterile recalled | The Compounding Pharmacy of America | Sterility | Nationwide |