Class III — Low Risk

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

Morphine Sulfate Extended-Release Tablets Recalled by LUPIN SOMERSET Due to Failed Impurities/Degradation Specifications

Date: April 10, 2019
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

Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01

Quantity: 17,328 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications

Where Was This Sold?

Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.

About LUPIN SOMERSET

LUPIN SOMERSET has 13 total recalls tracked by RecallDetector.

Related Recalls

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