Class II — Potential Health Hazard

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

Ranitidine 150 mg tablets Recalled by AAA Pharmaceutical, Inc. Due to CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Date: December 26, 2019
Company: AAA Pharmaceutical, Inc.
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 AAA Pharmaceutical, Inc. directly.

Affected Products

Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.

Quantity: 34,272 (24-count bottles)

Why Was This Recalled?

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

Where Was This Sold?

Product was distributed to one consignee who may have distributed the product further to their retail stores.

About AAA Pharmaceutical, Inc.

AAA Pharmaceutical, Inc. has 4 total recalls tracked by RecallDetector.

Related Recalls

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