Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III · Low risk Ongoing Initiated Sep 12, 2025 (13 months ago)

Espumil

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

Why it was recalled

Labeling: Not Elsewhere Classified

Cause type: Labeling / mix-up

Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.

What was recalled

Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604

Recalling firm
Letco Medical LLC
Origin
AL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0138-2026 · 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.

Other recalls by Letco Medical LLC

All 2025 recalls

Other labeling / mix-up recalls from 2025

All labeling / mix-up recalls
Class II · Moderate risk

Levothyroxine Sodium Tablets

Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.

Ongoing Labeling / mix-up Alvogen, Inc D-0259-2026
Class III · Low risk

parodontax

Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.

Ongoing Labeling / mix-up Haleon US Holdings LLC NDC 0135-0651-02 D-0297-2026
Class I · High risk

POTASSIUM CHLORIDE Inj.

Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq

Ongoing Labeling / mix-up Otsuka ICU Medical LLC NDC 0990-7074-26 D-0181-2026