West-Ward Recalls Fentanyl Citrate Injections Due to Impurity Failures
West-Ward Pharmaceutical is recalling Fentanyl Citrate injections because the product failed impurity and degradation specifications and 12-month stability testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is unlikely to cause adverse health consequences. The failure of impurity and stability specifications represents a quality control issue that warrants a moderate severity rating under the rubric for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
West-Ward Pharmaceutical Corporation is recalling Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials. The product is intended for intravenous or intramuscular use and is preservative-free. The recall covers 445,475 vials distributed nationwide.
The recall was initiated because the product failed impurities and degradation specifications as well as 12-month stability testing. The affected lots are 113312 (Exp 11/2015) and 014315 (Exp 01/2016). The FDA has classified this recall as Class III.
Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- FENTANYL CITRATE (FENTANYL CITRATE)
- Brand
- FENTANYL CITRATE
- Manufacturer
- West-Ward Pharmaceutical Corporation
- Category
- Drug — Prescription Injection
- Affected units
- 445,475
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 113312
- Exp 11/2015
- 014315 Exp 01/2016
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · FENTANYL CITRATE
- SeverePfizer Recalls Fentanyl Citrate Injections Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-08-12
- ModerateWest-Ward Recalls Fentanyl Citrate Injection Due to Impurity Failures
FDA (Drugs) · 2015-06-24
- SevereHospira Recalls Fentanyl Citrate Injection Due to Sterility Concerns
FDA (Drugs) · 2014-12-17
- SevereHospira Recalls Fentanyl Citrate Injection Due to Sterility Concerns
FDA (Drugs) · 2014-07-23
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17