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.

Alinia (nitazoxanide) Recalled by Romark Laboratories, L.C. Due to Failed Stability Specifications: Product failed to meet 12...

Date: April 24, 2015
Company: Romark Laboratories, L.C.
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 Romark Laboratories, L.C. directly.

Affected Products

Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured for Lupin Pharmaceuticals Inc, Baltimore, Maryland 21202 for Romark Laboratories 3000 Bayport Dr. Suite 200, Tampa, FL 33607

Quantity: 32,893 bottles

Why Was This Recalled?

Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Romark Laboratories, L.C.

Romark Laboratories, L.C. has 1 total recall tracked by RecallDetector.

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