The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1511-2022·Announced 2022-09-21

OTC Magnesium Citrate Laxative Recalled for Manufacturing Process Deviations

Magnesium citrate saline laxative products branded as CITROMA and multiple retail equivalents are subject to a Class II recall due to manufacturing process deviations. The voluntary recall affects millions of bottles distributed nationwide and internationally.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall for manufacturing process deviations without any reported illnesses, injuries, or specific product defects. This is a voluntary, precautionary recall by the manufacturer, consistent with Moderate severity for manufacturing compliance issues.

Plain-English summary

CITROMA brand magnesium citrate saline laxative, supplied as a 10 fl oz oral solution, is the subject of a Class II recall due to Current Good Manufacturing Practice (CGMP) deviations. The same product is distributed under multiple retail and store brands, including CVS Health, Walmart Equate, Kroger, Publix, Walgreens, Target, and others.

The recall encompasses over 22 million bottles with all lots remaining within their expiration dates. Distribution included the United States, Canada, and Panama. This is a voluntary recall initiated by the manufacturer, Vi-Jon, LLC. The recall was officially terminated on May 9, 2024.

The recalled product

Product
CITROMA (MAGNESIUM CITRATE)
Brand
CITROMA
Manufacturer
Vi-Jon, LLC
Category
Drug — Oral Laxative / OTC
Hazard
Affected units
22,965,330

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 (1)

  • All lots remaining within expiry.

UPCs (33)

  • 0041163503816
  • 0321130779155
  • 050428335178
  • 050428305942
  • 070038200499
  • 341520313226
  • 646702057012
  • 308697403082
  • 093351028205
  • 041163500679
  • 681131287142
  • 614299404205
  • 032251580826
  • 846036007374
  • 072036726124
  • 041220510863
  • 052569142158
  • 041260001826
  • 096295135541
  • 309046787440
  • 713733459457
  • 840986035302
  • 041415506732
  • 635515901254
  • 072785134188
  • 011822433006
  • 321130779155
  • 072785114791
  • 010939908445
  • 072785134058
  • 036800455290
  • 072785128835
  • 311917201603

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 →

Related recalls

Same brand · CITROMA

Same manufacturer · Vi-Jon, LLC

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Same hazard · cgmp deviation

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