Magnesium Citrate Liquid
FDA Recall NDC 0363-0427

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 1 recorded enforcement report(s) associated with Magnesium Citrate (NDC 0363-0427). A significant event, classified as Class II, was initiated on Dec 21, 2023 by Walgreen Company. The reported reason for this action was: "MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria."

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

December 2023 Class II Recall: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Recall Number
Class II Ongoing
Reason for Recall
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Initiated
Dec 21, 2023
Reported
Jan 24, 2024
Quantity
49,716 Bottles

Recall Profile & Regulatory Data

Event ID
93682
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Pharma Nobis LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Product Description
Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Free Low Sodium, Grape flavor 10 fl. oz, Distributed by: Walgreen Co, 200 Wilmot Rd, Deerfield, IL 60015, NDC 0363-0427-98.
Batch or Lot Expiration Information
Lot# Lot A80623; Exp. 11/30/2025
Affected Packages Involved in this Recall
0363-0427-98Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.