Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Fentanyl Citrate Inj. Recalled by West-Ward Pharmaceutical Corporation Due to Failed Impurities/Degradation Specifications; 12 month stability testing.

Date: February 16, 2015
Company: West-Ward Pharmaceutical Corporation
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact West-Ward Pharmaceutical Corporation directly.

Affected Products

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.

Quantity: 445,475 Vials

Why Was This Recalled?

Failed Impurities/Degradation Specifications; 12 month stability testing.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About West-Ward Pharmaceutical Corporation

West-Ward Pharmaceutical Corporation has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report