The Recall Desk
Agency classClass IOur severity: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.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. 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
Category
Drug — Oral Laxative
Hazard
Affected units
42,912

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.

Part of a larger recall action

This product is one of 14 recalled by Vi-Jon, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

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