FDA Recalls Citroma Magnesium Citrate Laxative for Manufacturing Deviations
Vi-Jon is recalling Citroma magnesium citrate oral laxative due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects units 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: This is a voluntary precautionary FDA Class II recall due to manufacturing process deviations. No specific safety hazard or adverse events are documented in the source material.
Plain-English summary
Vi-Jon, LLC is recalling Citroma magnesium citrate saline laxative oral solution due to Current Good Manufacturing Practice (CGMP) deviations. The recalled product is a 1.745 g magnesium citrate oral solution in 10 fl oz (296 mL) bottles with cherry flavor. This is an FDA Class II recall initiated voluntarily by the firm.
The recall affects approximately 10,070,526 units distributed nationwide in the United States, as well as Canada and Panama. The product was marketed under multiple store brands including Best Choice, Careone, CVS Health, Equaline, Equate, Family Wellness, GoodSense, H-E-B, Health Mart, Leader, Meijer, Premier Value, Publix, Quality Choice, Rexall, Rite Aid, Signature Care, Sunmark, Swan, TopCare, and Walgreens. All affected lots remain within their expiration dates.
The recall was initiated by the firm on July 15, 2022, and was terminated on May 9, 2024.
The recalled product
- Product
- CITROMA (MAGNESIUM CITRATE)
- Brand
- CITROMA
- Manufacturer
- Vi-Jon, LLC
- Category
- Drug — OTC Laxative
- Hazard
- Affected units
- 10,070,526
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 (26)
- 0846036009507
- 0321130789710
- 0072785143890
- 070038587903
- 341520000553
- 050428297339
- 050428285152
- 041163500686
- 681131287166
- 032251577888
- 846036007398
- 041220510870
- 052569142165
- 096295141061
- 096295141054
- 713733459440
- 840986035296
- 041415505735
- 635515901117
- 072785134164
- 011822433037
- 321130789710
- 010939910448
- 308690693381
- 036800455306
- 311917201580
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
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- SevereOTC Magnesium Citrate Laxative Recalled for Microbial Contamination
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FDA (Drugs) · 2022-09-21
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