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.

Major Infants' Gas Relief Drops Recalled by GCP Laboratories Inc Due to Microbial Contamination of Non-Sterile Product.

Date: September 18, 2019
Company: GCP Laboratories 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 GCP Laboratories Inc directly.

Affected Products

Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-5894-30

Quantity: 31,392 30 mL bottles

Why Was This Recalled?

Microbial Contamination of Non-Sterile Product.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GCP Laboratories Inc

GCP Laboratories Inc has 1 total recall tracked by RecallDetector.

Related Recalls

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