Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial Recalled by Teva Pharmaceuticals USA Due to Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained...

Date: September 27, 2018
Company: Teva Pharmaceuticals USA
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 Teva Pharmaceuticals USA directly.

Affected Products

Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02

Quantity: 1,362 vials

Why Was This Recalled?

Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing

Where Was This Sold?

Product was distributed throughout the United States, including Hawaii and Puerto Rico.

About Teva Pharmaceuticals USA

Teva Pharmaceuticals USA has 196 total recalls tracked by RecallDetector.

Related Recalls

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