Class III โ€” Low Risk

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

Hydrocodone Bitartrate and Acetaminophen Tablets Recalled by LUPIN SOMERSET Due to Labeling: Missing Label

Date: May 24, 2018
Company: LUPIN SOMERSET
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 LUPIN SOMERSET directly.

Affected Products

Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102

Quantity: 1,672 (1000-count) bottles

Why Was This Recalled?

Labeling: Missing Label

Where Was This Sold?

This product was distributed to 1 state: OH

Affected (1 state)Not affected

About LUPIN SOMERSET

LUPIN SOMERSET has 13 total recalls tracked by RecallDetector.

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