The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1500-2022·Announced 2022-09-21

CVS Health Magnesium Citrate Saline Laxative recalled for microbial contamination

CVS Health Magnesium Citrate Saline Laxative is being recalled due to potential microbial contamination of the non-sterile product. Approximately 241,086 bottles were distributed nationwide.

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: The product carries an FDA Class I classification. Per the severity rubric, FDA Class I recalls are rated Critical.

Plain-English summary

CVS Health Magnesium Citrate Saline Laxative, a 10 fl oz oral solution containing 1.745 g/fl oz magnesium citrate, is being recalled. The product is manufactured by Vi-Jon, LLC and distributed by CVS Pharmacy, Inc., Woonsocket, RI.

The recall is due to potential microbial contamination of the non-sterile product. Approximately 241,086 bottles are subject to this recall.

The product was distributed nationwide in the USA, as well as in Canada and Panama. Affected lot numbers include: 0556808 (expiring 12/8/2023), 0563095 (expiring 2/18/2024), 0562243 (expiring 2/17/2024), 0557622 (expiring 1/12/2024), and 0498395 (expiring 8/8/2022). The product can be identified by UPC codes 0 50428 30594 2 or 0 50428 33517 8.

The recalled product

Product
CVS Health, Magnesium Citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), a) UPC 0 50428 30594 2; b) UPC 0 50428 33517 8; Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.
Manufacturer
Vi-Jon, LLC
Category
Drug — Laxative
Hazard
Affected units
241,086

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 (10)

  • Lot# (a) 0556808
  • EXP 12/8/2023
  • 0563095
  • EXP 2/18/2024
  • 0562243
  • EXP 2/17/2024
  • 0557622
  • EXP 1/12/2024
  • (b) 0498395
  • EXP 8/8/2022

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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