CLASS III Drug recall · Reported 1 Apr 2015 · FDA Enforcement Report
Fentanyl Citrate Inj., USP, CII, 250 mcg/ (50 mcg/mL) recalled
West-Ward Pharmaceutical is recalling Fentanyl Citrate Inj., USP, CII, 250 mcg/ (50 mcg/mL) (0.05 mg/mL) mL Single Dose Vials, distributed nationwide in the US. The recall was initiated on 16 Feb 2015 and the FDA has classified it as Class III.
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-0420-2015
- FDA event ID
- 70548
- Recalling firm
- West-Ward Pharmaceutical, Cherry Hill, NJ
- Brand
- Fentanyl Citrate
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Feb 2015
- FDA classified
- 20 Mar 2015
- Reported
- 1 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 16 Feb 2015 | Recall initiated by company | |
| 20 Mar 2015 | Classified by FDA | +32 days |
| 1 Apr 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications; 12 month stability testing.
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 Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications; 12 month stability testing.
Which lots are affected?
Lot #: 113312, Exp 11/2015; 014315 Exp 01/2016
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 West-Ward Pharmaceutical
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PredniSONE Tablets USP, 1 mg recalled by West-Ward PharmaceuticalPrednisone | West-Ward Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Fentanyl Citrate Inj., USP, CII, 250 mcg/ (50 mcg/mL) (0.05 mg/mL) recalledFentanyl Citrate | West-Ward Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS II | Versapharm Incorporated Ethambutol Hydrochloride Tablets recalled | West-Ward Pharmaceutical | Potency & Assay | GA |
| Drug | CLASS II | Isoniazid Tablets, USP, 300 mg recalled by West-Ward Pharmaceutical | West-Ward Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS II | Carisoprodol Tablets, USP 350 mg recalled by West-Ward Pharmaceutical | West-Ward Pharmaceutical | Lead & Heavy Metals | Nationwide |
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, Sterile CADD for Injection, 2,2500 mcg recalled | IntegraDose Compounding Services | Potency & Assay | 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 |