The Recall Desk
CriticalFDA (Drugs)·D-1506-2022·Announced 2022-09-21

FDA Recalls Citroma Magnesium Citrate Laxative for Microbial Contamination

Citroma magnesium citrate laxative is recalled due to microbial contamination. The FDA Class I recall affects 42,912 bottles distributed in the USA, Canada, and Panama.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I classification for a non-sterile drug product with microbial contamination. FDA Class I is explicitly recognized as a criterion for Critical severity, indicating serious health hazard risk.

Plain-English summary

Citroma brand magnesium citrate oral laxative solution is being recalled by Vi-Jon, LLC due to microbial contamination of the non-sterile product. The product is a 10 FL OZ (296 mL) oral solution with lemon flavor.

The recall involves specific lot numbers 0511629 (expiring 12/4/2022) and 0562243 (expiring 2/17/2024), affecting 42,912 bottles total. The product was distributed nationwide in the United States, as well as in Canada and Panama. It is identified by NDC 55910-183-38 and UPC 072785134188.

This is an FDA Class I recall issued due to microbial contamination of the non-sterile product. Consumers with questions about this recall should consult the FDA drug recall database or their healthcare provider.

The recalled product

Product
CITROMA (MAGNESIUM CITRATE)
Brand
CITROMA
Manufacturer
Vi-Jon, LLC
Hazard
  • microbial-contamination

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 (4)

  • Lot # 0511629
  • EXP 12/4/2022
  • 0562243
  • EXP 2/17/2024

UPCs (1)

  • 072785134188

Distribution

Distributed nationwide across the United States.