Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III · Low risk Terminated Initiated Jan 16, 2013 (14 years ago)

Ventavis (iloprost)

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.

Cause type: Wrong potency / content

Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.

What was recalled

Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc, 5000 Shoreline Court, Ste 200, South San Francisco, CA 94080, NDC: 66215-302-30.

Affected NDC 66215-0302-30

Compare with the code on your package — it is the most precise check available.

Recalling firm
Actelion Pharmaceuticals U.S., Inc.
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-143-2013 · 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 wrong potency / content recalls from 2013

All wrong potency / content recalls
Class II · Moderate risk

Clonazepam Tablets

Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.

Terminated Wrong potency / content Actavis Elizabeth LLC NDC 0228-3005-11 D-1087-2014