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 Syrup (Ranitidine Oral Solution USP) Recalled by American Health Packaging Due to CGMP Deviations: Presence of NDMA impurity detected in...

Date: November 1, 2019
Company: American Health Packaging
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 American Health Packaging directly.

Affected Products

Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)

Quantity: 1,692 cases of 40 and 50 cups

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 American Health Packaging

American Health Packaging has 56 total recalls tracked by RecallDetector.

Related Recalls

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