Class II · Moderate risk
fentaNYL Citrate
Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Subpotent Drug
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-074-16, UPC: 0100352533074165
Affected NDC
52533-0074-16
Compare with the code on your package — it is the most precise check available.
Drug: Fentanyl
- Recalling firm
- Cantrell Drug Company
- NDC code
- 52533-074-16
- Origin
- AR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1158-2016 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fentanyl recalls
See all
Class II · Moderate risk
fentaNYL Citrate
Subpotent Drug
Class II · Moderate risk
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate Injectable Solution
cGMP deviations.
Other recalls by Cantrell Drug Company
All 2015 recalls
Class II · Moderate risk
Rocuronium Bromide Injection Solution 5 mL
Lack of Sterility Assurance.
Class II · Moderate risk
Neostigmine Methylsulfate Injection Solution 5 mL
Lack of Sterility Assurance.
Class II · Moderate risk
Adenosine in 0.9% Sodium Chloride 30mL
Lack of Sterility Assurance.
Class II · Moderate risk
Sodium Bicarbonate 8.4% Injection Solution 50 mL
Lack of Sterility Assurance.
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