Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Oct 19, 2015 (11 years ago)

Podophyllum 40% Topical

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility

Cause type: Sterility / contamination

A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.

What was recalled

Podophyllum 40% Topical, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

Drug: Podophyllum

Recalling firm
Western Drug
Origin
AZ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0442-2016 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Podophyllum recalls

See all
Class II · Moderate risk

Podophyllum Resin active pharmaceutical ingredient packaged in…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-846-2015

Other recalls by Western Drug

All 2015 recalls