Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1513-2022·Announced 2022-09-21

Magnesium Citrate Saline Laxative Recalled for Manufacturing Deviations

Vi-Jon, LLC voluntarily recalled Magnesium Citrate Saline Laxative due to manufacturing process deviations. Over 8 million units of the product were distributed nationwide.

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 voluntary recall with CGMP manufacturing deviations. No illnesses, injuries, or hospitalizations are reported. This is a precautionary manufacturing compliance issue.

Plain-English summary

Vi-Jon, LLC issued a voluntary recall of Magnesium Citrate Saline Laxative oral solution (10 FL OZ / 296 mL bottles, 1.745 g per bottle) in grape flavor. The recall affects a total of 8,064,834 units distributed nationwide in the United States, as well as in Canada and Panama.

The recall was initiated due to CGMP (Current Good Manufacturing Practice) deviations identified by the manufacturer. CGMP deviations represent departures from federal manufacturing standards required for pharmaceutical production and may affect product quality and safety.

The affected product was distributed under multiple store brands, including Best Choice, CVS Health, Equate, H-E-B, Kroger, Leader, Rexall, and Walgreens. All lots remaining within their expiration date were included in the recall. The firm voluntarily initiated the recall, and it was terminated in May 2024 following resolution of the manufacturing issues.

The recalled product

Product: Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Grape Flavor, 10 FL OZ (296 mL), a) Best Choice UPC 0 70038 66220 4 Proudly Distributed By: Valu Merchandisers, Co. 5000 Kansas Ave Kansas City, KS 66106; b) CVS Health UPC 0 50428 30745 8 Distributed by: CVS Pharmacy…
Manufacturer: Vi-Jon, LLC
Category: Drug — Over-the-Counter Saline Laxative
Hazard: manufacturing-defect
Affected units: 8,064,834

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.

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 manufacturer · Vi-Jon, LLC

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Same hazard · manufacturing defect