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Stop using now Drug recall · FDA · Published September 18, 2019

Major Infants' Gas Relief Drops Recalled for Microbial Contamination

Major Pharmaceuticals recalls 30 mL bottles of Infants' Gas Relief Drops due to microbial contamination. Check your bottle's lot number and expiration date.

🇺🇸 FDA recall #D-0126-2020DrugMajor ›
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Recalling firmGCP Laboratories Inc3600 25th Ave · Gulfport, MS 39501-6922
✎ GovInfoNow plain-language explainer

GCP Laboratories Inc is recalling Major Infants' Gas Relief Drops, a Simethicone Oral Suspension USP, because the product contains microbial contamination. The affected items are 1 FL OZ (30 mL) bottles distributed by Major Pharmaceuticals. This recall affects approximately 31,392 bottles. Read more at govinfonow.com/recall/37925-major-infants-gas-relief-drops-recalled-for-microbial-contamination.

Source Summary by GovInfoNow · govinfonow.com/recall/37925-major-infants-gas-relief-drops-recalled-for-microbial-contamination · Updated October 11, 2026 · FDA enforcement record: FDA #D-0126-2020

Cite this page

“Major Infants' Gas Relief Drops Recalled for Microbial Contamination.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/37925-major-infants-gas-relief-drops-recalled-for-microbial-contamination. Based on FDA recall #D-0126-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0126-2020%22&limit=1).

GCP Laboratories Inc recalled Major Infants' Gas Relief Drops distributed by Major Pharmaceuticals due to microbial contamination risk, according to the FDA. The Food and Drug Administration announced the Class II recall on Sept. 18, 2019. Owners should contact the company for a refund.

How to tell if you have it

  • Brand: Major
  • Product: Infants' Gas Relief Drops (Simethicone Oral Suspension USP)
  • Size: 1 FL OZ (30 mL) bottle
  • NDC: 0904-5894-30
  • Lot code: WBD003
  • Expiration date: 03/21
  • Units affected: 31,392 bottles

The hazard

The product poses a risk of microbial contamination because it is a non-sterile product. The FDA classified the recall as Class II.

Context

GovInfoNow's records show other recent recalls involving microbial or bacterial contamination include Walgreens Saline Nasal Spray with Xylitol (Nov. 12, 2025), Zep Alcohol Sanitizer Spray (May 22, 2026), and Victory Medical Center Pharmacy Glutathione Vials (July 1, 2026).

How to tell if you have this one

Look for Major Infants' Gas Relief Drops in a 1 FL OZ (30 mL) bottle. Check the label for NDC 0904-5894-30 and Lot number WBD003 with an expiration date of 03/21. The product was distributed nationwide, so it may have been sold in various locations.

  • Brand
    Major
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Stop Using the Product

    Do not give this medication to your infant if you have a bottle matching the recalled lot number.

  2. Check Your Bottle Details

    Verify that your bottle has NDC 0904-5894-30 and Lot WBD003 with an expiration date of 03/21.

  3. Contact the Distributor

    Reach out to Major Pharmaceuticals for further instructions on disposal or return, as specific remedy details are not provided in this record.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Distributed in MI and further distributed Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

1. Firm started the recall: Sep 18, 201912. FDA classified it Class II: Oct 7, 201923. Published in FDA’s Enforcement Report: Oct 16, 201934. FDA terminated the recall: Feb 5, 2021420192021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

How many bottles are affected by this recall?

Approximately 31,392 bottles of 30 mL size are included in this recall.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0126-2020 (September 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0126-2020 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA