Class II โ€” Potential Health Hazard

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

Nitrofurantoin Oral Suspension USP Recalled by LUPIN SOMERSET Due to Subpotent Drug and Failed Content Uniformity.

Date: June 28, 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

Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11

Quantity: 3456 cartons

Why Was This Recalled?

Subpotent Drug and Failed Content Uniformity.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)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