Ecometics Unguentine Original Maximum Strength Pain Recall

Why it was recalled

CGMP DEVIATIONS

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide within the United States

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0452-2023
Classification: Class II
Status: Terminated
Recall initiated: Feb 24, 2023
FDA report date: Mar 15, 2023
Recall type: Voluntary: Firm initiated
Recalling firm: Ecometics, Inc.

Original FDA data

Every field from FDA enforcement report D-0452-2023, exactly as published.

Show all FDA fields

City: Norwalk
State: CT
Status: Terminated
Country: United States
Event ID: 91719
Address: 19 Concord St
Code information: Lot #: 1E346A, Exp. Date Nov-23; 2E304A, Exp. Date Oct-24
Postal code: 06854-3706
Report date: Mar 15, 2023
Product type: Drugs
Recall number: D-0452-2023
Classification: Class II
Recalling firm: Ecometics, Inc.
Termination date: Jun 21, 2023
Reason for recall: CGMP DEVIATIONS
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Nationwide within the United States
Recall initiation date: Feb 24, 2023
Initial firm notification: Letter
Center classification date: Mar 8, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0452-2023, published Mar 15, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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