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.

RANITIDINE TABLETS Recalled by Granules India Limited Due to CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Date: December 13, 2019
Company: Granules India Limited
Status: Ongoing
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 Granules India Limited directly.

Affected Products

RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32

Quantity: 23,090,000 tablets

Why Was This Recalled?

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Where Was This Sold?

This product was distributed to 3 states: NJ, NY, OR

Affected (3 states)Not affected

About Granules India Limited

Granules India Limited has 1 total recall tracked by RecallDetector.

Related Recalls

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