Class I (most serious) Drug D-0553-2026 Ongoing

FDA Class I recall: Staphylococcus aureus in MG217 skin cream — microbial contamination of a non-sterile product

Wisconsin Pharmacal Company ・Reported May 27, 2026

Wisconsin Pharmacal recalled an over-the-counter MG217 multi-symptom treatment cream (colloidal oatmeal 2%) after confirming the presence of Staphylococcus aureus. The FDA classified it Class I.

Recall overview (primary data)

ClassificationClass I (most serious)
Product typeDrug
Recalling firmWisconsin Pharmacal Company
ReasonMicrobial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
DistributionUSA Nationwide and Bahamas
Recall initiated2026-04-24

Key points

Staphylococcus aureus in MG217 skin cream (colloidal oatmeal 2%)
FDA classified it Class I (D-0553-2026, reported May 27, 2026, ongoing)
Microbial contamination of a non-sterile product; about 690 tubes, U.S. and Bahamas
Can cause infection in broken skin or people with weakened immunity

The U.S. FDA classified Wisconsin Pharmacal's recall of an OTC skin cream as Class I (recall D-0553-2026, reported May 27, 2026, status ongoing, firm-initiated).

The affected product is "MG217 Multi-Symptom Treatment Cream & Skin Protectant" (active ingredient colloidal oatmeal 2%, NET WT 6 oz / 170 g, manufactured by Pharmacal, Jackson, WI). The recall reason is microbial contamination of a non-sterile product — confirmed presence of Staphylococcus aureus. The recall was initiated April 24, 2026, affecting about 690 tubes, distributed U.S. nationwide and the Bahamas.

Staphylococcus aureus is a bacterium that normally lives on skin but can cause infection in broken skin or in people with weakened immunity. A contaminated product applied to the skin raises infection risk, especially where the skin barrier is compromised — the basis for the most serious Class I classification.

Why it matters

A Class I OTC drug recall distributed in the U.S. and the Bahamas. Relevant for personal imports / cross-border purchases of U.S. OTC products, and an example of the importance of microbial control in non-sterile topical products.

FAQ

What is Staphylococcus aureus?

A bacterium that normally lives on skin but can cause infection in broken skin or people with weakened immunity. A contaminated topical product raises infection risk.

Is it sold outside the U.S.?

FDA records show U.S. and the Bahamas, not direct distribution elsewhere. If you obtained it via personal import, check the official FDA information.

Sources (primary)

Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.

#FDA#Recall#Drug#OTC#Class I#Staph aureus

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