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.

Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Recalled by Novitium Pharma LLC Due to CGMP Deviations: Presence of NDMA impurity detected in...

Date: October 25, 2019
Company: Novitium Pharma 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 Novitium Pharma LLC directly.

Affected Products

Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20

Quantity: 19560 bottles

Why Was This Recalled?

CGMP Deviations: Presence of NDMA impurity detected in product.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Novitium Pharma LLC

Novitium Pharma LLC has 6 total recalls tracked by RecallDetector.

Related Recalls

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