The Recall Desk
SevereFDA (Drugs)·D-0126-2020·Announced 2019-10-16

Major Infants' Gas Relief Drops Recalled for Microbial Contamination

GCP Laboratories is recalling Major Infants' Gas Relief Drops due to microbial contamination of the non-sterile product.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the source text explicitly cites microbial contamination, which aligns with the rubric criteria for Severe severity involving significant health risks.

Plain-English summary

GCP Laboratories Inc is recalling Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottles. The recall is due to microbial contamination of the non-sterile product.

The affected product is identified by Lot WBD003 with an expiration date of 03/21. The recall covers 31,392 bottles. The product was distributed in Michigan and further distributed nationwide.

Consumers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
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
Manufacturer
GCP Laboratories Inc
Category
Drug — Infant Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: WBD003 Exp. 03/21

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same hazard · microbial contamination

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