Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

APLENZIN¿ (bupropion hydrobromide) Recalled by Valeant Pharmaceuticals North America LLC Due to Labeling: Incorrect or Missing Package Insert

Date: June 5, 2014
Company: Valeant Pharmaceuticals North America LLC
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 Valeant Pharmaceuticals North America LLC directly.

Affected Products

APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (NDC 0024-5812-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7

Quantity: 55,650 HDPE bottles

Why Was This Recalled?

Labeling: Incorrect or Missing Package Insert

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Valeant Pharmaceuticals North America LLC

Valeant Pharmaceuticals North America LLC has 25 total recalls tracked by RecallDetector.

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