Agency classClass IOur severity:Severe FDA (Drugs)·D-1508-2022·Announced 2022-09-21

OTC Magnesium Citrate Laxative Recalled for Microbial Contamination

Vi-Jon's CITROMA magnesium citrate laxative is recalled due to microbial contamination. Approximately 18,588 bottles were distributed nationwide 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall for microbial contamination in an oral drug product. The agency's Class I classification requires a minimum severity score of 4, indicating serious potential for adverse health effects.

Plain-English summary

Vi-Jon, LLC is recalling CITROMA (magnesium citrate) saline laxative oral solution due to microbial contamination. The recalled product is a cherry-flavored 10 FL OZ (296 mL) bottle with lot number 0546394 and expiration date 9/29/2023 (NDC 36800-164-38).

Microbial contamination in oral medications can pose health risks to consumers.

Approximately 18,588 bottles of the affected lot were distributed nationwide in the United States, Canada, and Panama.

Consumers who purchased this product should stop using it immediately. Anyone who has used this product and experienced adverse effects should contact their healthcare provider.

The recalled product

Product: CITROMA (MAGESIUM CITRATE)
Brand: CITROMA
Manufacturer: Vi-Jon, LLC
Category: Drug
Hazard: microbial-contamination
Affected units: 18,588

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 (2)

Lot # 0546394
EXP 9/29/2023

UPCs (1)

036800455306

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 →

Same brand · CITROMA

Moderate
FDA Recalls Citroma Magnesium Citrate Laxative for Manufacturing Deviations
FDA (Drugs) · 2022-09-21
Severe
FDA Recalls CITROMA Magnesium Citrate for Microbial Contamination
FDA (Drugs) · 2022-09-21
Moderate
OTC Magnesium Citrate Laxative Recalled for Manufacturing Process Deviations
FDA (Drugs) · 2022-09-21
Critical
FDA Recalls Citroma Magnesium Citrate Laxative for Microbial Contamination
FDA (Drugs) · 2022-09-21

Same manufacturer · Vi-Jon, LLC

See all →

Moderate
Kroger Mint Burst Antiseptic Mouth Rinse recalled for undeclared excipients
FDA (Drugs) · 2023-09-27
Severe
FDA Recalls Kroger Magnesium Citrate Laxative for Microbial Contamination
FDA (Drugs) · 2022-09-21
Severe
Magnesium Citrate Laxative Recalled Due to Microbial Contamination
FDA (Drugs) · 2022-09-21
Severe
SWAN Citroma Saline Laxative Recalled for Microbial Contamination
FDA (Drugs) · 2022-09-21
Critical
CVS Health Magnesium Citrate Saline Laxative recalled for microbial contamination
FDA (Drugs) · 2022-09-21

Same hazard · microbial contamination