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 Inj.
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25.
Affected NDC
0641-6028-25
Compare with the code on your package — it is the most precise check available.
Drug: Fentanyl
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Fentanyl Citrate NDC 00641-6028 |
50 ug/mL | Injection Intramuscular|intravenous |
Hikma Pharmaceuticals USA Inc. | Rx · CII |
- Recalling firm
- West-Ward Pharmaceutical Corp.
- NDC code
- 0641-6028-25
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1139-2015 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 West-Ward Pharmaceutical Corp.
All 2015 recalls
Class II · Moderate risk
PredniSONE Tablets USP
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
Class III · Low risk
Fentanyl Citrate Inj.
Failed Impurities/Degradation Specifications; 12 month stability testing.
Class II · Moderate risk
VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
Class II · Moderate risk
Isoniazid Tablets
Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
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