Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Omega-3-Acid Ethyl Esters Capsules USP Recalled by Teva Pharmaceuticals USA Due to API material used in the manufacturing of the...

Date: July 16, 2018
Company: Teva Pharmaceuticals USA
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Teva Pharmaceuticals USA directly.

Affected Products

Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89

Quantity: 13,715 120-count bottles

Why Was This Recalled?

API material used in the manufacturing of the product did not receive regulatory approval prior to release.

Where Was This Sold?

Product was distributed throughout the United States

About Teva Pharmaceuticals USA

Teva Pharmaceuticals USA has 196 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report