The Recall Desk
ModerateFDA (Drugs)·D-0447-2023·Announced 2023-03-15

Medicated Balm Recalled for Manufacturing Process Deviations

Ecometics, Inc. is voluntarily recalling Vencedor medicated balm (capsaicin 0.028%) nationwide due to manufacturing process deviations. The recall affects Lot #2E021A with expiration date January 2025.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall initiated voluntarily by the firm due to manufacturing process deviations with no reported illnesses or injuries. This falls within the rubric category of voluntary precautionary recalls, which are classified as Moderate severity.

Plain-English summary

Ecometics, Inc., in cooperation with The Larkspur Group Inc., is voluntarily recalling Vencedor medicated balm, a topical product containing 0.028% capsaicin supplied in 1.5 oz. (43g) tubes. The recall encompasses 4,210 units.

The recall was initiated due to Current Good Manufacturing Practices (CGMP) deviations discovered in the manufacturing process. The FDA classified this as a Class II recall. No illnesses or injuries have been reported in association with this product.

The affected product was distributed nationwide throughout the United States. The recalled product is identified by Lot #2E021A with an expiration date of January 2025.

The recalled product

Product
Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group Inc. Norwalk, CT 06854
Manufacturer
Ecometics, Inc.
Category
Drug — Topical Medicated Balm
Hazard
  • manufacturing-deviation

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 (2)

  • Lot #: 2E021A
  • Exp. Date Jan-25

Distribution

Distributed nationwide across the United States.

Related recalls

Same category