The Recall Desk
HighFDA (Drugs)·D-0213-2026·Announced 2025-12-10

Menthol and Zinc Oxide Topical Drug Recalled for Manufacturing Practice Deviations

Blossom Pharmaceuticals recalls Wecare Calasoothe, an over-the-counter menthol and zinc oxide topical product, due to manufacturing practice deviations. The recall affects 2,400 containers distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II classification indicates risk of harm from manufacturing practice deviations. No illnesses or injuries are reported in the source; per the rubric, this limits the score to High (3) rather than Severe.

Plain-English summary

Blossom Pharmaceuticals is recalling Wecare Calasoothe, an over-the-counter topical product containing menthol and zinc oxide, due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing.

The recall affects 2,400 containers with lot number A482305, distributed nationwide in the United States. The affected product has NDC 67777-234-04.

Consumers who have purchased this product should discontinue use and contact their pharmacist or healthcare provider. Anyone with questions can reach out to Blossom Pharmaceuticals for more information.

The recalled product

Product
MENTHOL AND ZINC OXIDE (MENTHOL AND ZINC OXIDE)
Brand
MENTHOL AND ZINC OXIDE
Manufacturer
Blossom Pharmaceuticals
Category
Drug — Topical / Over-the-Counter
Hazard
  • manufacturing-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot #: A482305

UPCs (1)

  • 0616784127514

Distribution

Distributed nationwide across the United States.

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