CLASS II ONGOING Drug recall · Reported 24 Jan 2024 · FDA Enforcement Report

Freskaro refresh & revitalize Magnesium Citrate Saline recalled

Pharma Nobis is recalling Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape Flavor, distributed nationwide in the US. The recall was initiated on 21 Dec 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot A80553; Exp. 11/2025
NDC82645-311
UPC0382645311100
Quantity recalled53,268 Bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0230-2024
FDA event ID
93682
Recalling firm
Pharma Nobis, Texarkana, TX
Manufacturer
Pharma Nobis, LLC
Classification
Class II
Status
Ongoing
Recall initiated
21 Dec 2023
FDA classified
12 Jan 2024
Reported
24 Jan 2024
Type
Voluntary: Firm initiated
Customers notified by
E-Mail
Reason category
Sterility

Timeline

21 Dec 2023Recall initiated by company
12 Jan 2024Classified by FDA+22 days
24 Jan 2024Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr., Texarkana, TX 75501, NDC 82645-311-10.

Where it was distributed

Nationwide.

Nationwide

Questions about this recall

Is Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape Flavor recalled?

Yes. Pharma Nobis recalled Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape Flavor on 21 Dec 2023. The recall is Class II and its status is Ongoing. Recall number D-0230-2024.

Why was it recalled?

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Which lots are affected?

Lot A80553; Exp. 11/2025

Where was it sold?

Nationwide.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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