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.
What this means for you
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
- cgmp-deviation
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.
Related recalls
Same brand · CITROMA
- CriticalFDA Recalls Citroma Magnesium Citrate Laxative for Microbial Contamination
FDA (Drugs) · 2022-09-21
- SevereOTC Magnesium Citrate Laxative Recalled for Microbial Contamination
FDA (Drugs) · 2022-09-21
- SevereFDA Recalls CITROMA Magnesium Citrate for Microbial Contamination
FDA (Drugs) · 2022-09-21
- ModerateFDA Recalls Citroma Magnesium Citrate Laxative for Manufacturing Deviations
FDA (Drugs) · 2022-09-21
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