The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0452-2023·Announced 2023-03-15

Unguentine Original Pain Relief Ointment Recalled for Manufacturing Process Deviations

Unguentine Original Pain Relief Ointment is being recalled due to manufacturing process deviations. The FDA-led voluntary recall affects nationwide distribution.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 voluntary precautionary recall with no reported illnesses or injuries. The recall is due to manufacturing process deviations without a specific identified health hazard.

Plain-English summary

Ecometics, Inc. has initiated a voluntary recall of Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment due to manufacturing process deviations. The product is packaged in 1 oz. (28.3g) metal tubes containing Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, and other active ingredients.

The recall affects two lot numbers: 1E346A with expiration November 2023 and 2E304A with expiration October 2024. The product was distributed nationwide throughout the United States by Oakhurst Company, Levittown, New York.

Consumers who have purchased this product should stop using it immediately. Contact Ecometics, Inc. or Oakhurst Company for instructions on how to return the product or obtain additional information.

The recalled product

Product
Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged in 1 oz. (28.3g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
Manufacturer
Ecometics, Inc.
Category
Drug — Topical Ointment
Hazard

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 (4)

  • Lot #: 1E346A
  • Exp. Date Nov-23
  • 2E304A
  • Exp. Date Oct-24

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Ecometics, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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