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 Hydrochloride (powder) Recalled by Spectrum Laboratory Products Due to CGMP Deviations: Presence of NDMA impurity detected in...

Date: January 14, 2020
Company: Spectrum Laboratory Products
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 Spectrum Laboratory Products directly.

Affected Products

Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram

Quantity: N/A

Why Was This Recalled?

CGMP Deviations: Presence of NDMA impurity detected in product.

Where Was This Sold?

This product was distributed to 11 states: AZ, CA, FL, GA, NJ, PA, RI, SC, TX, UT, WY

Affected (11 states)Not affected

About Spectrum Laboratory Products

Spectrum Laboratory Products has 4 total recalls tracked by RecallDetector.

Related Recalls

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