CLASS I Drug recall · Reported 13 Jul 2016 · FDA Enforcement Report
fentaNYL Citrate 25 mcg/mL in 5% Dextrose Injection, in Syringe recalled
Cantrell Drug is recalling fentaNYL Citrate 25 mcg/mL in 5% Dextrose Injection, in Syringe, distributed nationwide in the US. The recall was initiated on 21 Aug 2015 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-1155-2016
- FDA event ID
- 72028
- Recalling firm
- Cantrell Drug, Little Rock, AR
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 21 Aug 2015
- FDA classified
- 6 Jul 2016
- Reported
- 13 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 21 Aug 2015 | Recall initiated by company | |
| 6 Jul 2016 | Classified by FDA | +320 days |
| 13 Jul 2016 | 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
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 25 mcg/mL in 5% DEXTROSE Injection, in 2 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock AR --- UPC: 9999993301
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot: 151142, exp 10/22/15
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 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.
Other products in this recall event
12 other products · FDA event 72028This product is part of a recall event; the main page for the event is Heparin Sodium in 0.45% Sodium Chloride, 1 USP Unit recalled.
More recalls from Cantrell Drug
All 52| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ephedrine Sulfate in 0.9% Sodium Chloride, 50 mg recalled | Cantrell Drug | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium recalled | Cantrell Drug | Sterility | Nationwide |
| Drug | CLASS II | Diltiazem HCl 125 mg in 5% Dextrose Single-Dose recalled | Cantrell Drug | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium recalled | Cantrell Drug | Sterility | Nationwide |
| Drug | CLASS II | Adenosine in 0.9% Sodium Chloride, 90 mg recalled by Cantrell Drug | Cantrell Drug | Sterility | Nationwide |