Carolina Infusion Tri-MIX Recall D-0024-2027 Recall

Carolina Infusion, LLC recalled Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, an injectable compounded product packaged in single-use dosage syringes, because of a lack of assurance of sterility related to processing equipment used in the compounded product. The FDA classified the action as a Class II recall, number D-0024-2027. The firm initiated the recall voluntarily on September 10, 2026. The recall is listed as ongoing in FDA’s enforcement data.

At a glance

• Recalling firm: Carolina Infusion, LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
• Product: Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, in patient-specific single-use dosage syringes.
• FDA recall number: D-0024-2027; classification: Class II.
• Reason given by FDA: “Lack of Assurance of Sterility: Related to processing equipment used in compounded product.”
• Recall initiation date: September 10, 2026; FDA center classification date: October 8, 2026; FDA report date: October 14, 2026.

What the recall covers

FDA’s enforcement record describes the affected product as Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, packaged in single-use dosage syringes, with total milliliters dispensed based on the dosage in a specific patient prescription. The firm is identified as Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. The product quantity is listed as 3 ML in a patient-specific syringe dose.

The record lists lot code information as Lot 08042026@8 with a beyond-use date (BUD, the date after which a compounded preparation should no longer be used) of 9/18/2026. FDA records the distribution pattern as nationwide within the United States. The initial firm notification method is listed as e-mail.

FDA’s public drug recall page explains that a recall is generally a voluntary action taken by a company to remove a defective drug from the market or to warn patients and consumers about a potential risk. That description is general and is not specific to this recall.

What “lack of assurance of sterility” means in this record

The stated reason for this recall is a lack of assurance of sterility tied to processing equipment used in the compounded product. In FDA’s own phrasing, the concern is about assurance of sterility rather than a confirmed finding that any syringe contained a contaminant.

This distinction matters for how the record reads. The recall reason identifies a sterility assurance gap connected to equipment used in processing. FDA’s enforcement entry for D-0024-2027 does not state that any patient became ill, that any product tested positive for a contaminant, or that a particular organism was identified. The record establishes the reason the firm gave for the recall and FDA’s classification of it. It does not include clinical findings or outcomes.

What is established vs. what is alleged

Established by the FDA enforcement record: Carolina Infusion, LLC initiated a voluntary recall of the identified Tri-MIX product; FDA assigned recall number D-0024-2027; FDA classified the recall as Class II; the reason listed is lack of assurance of sterility related to processing equipment; the recall was initiated on September 10, 2026, classified on October 8, 2026, and reported on October 14, 2026; and the status is ongoing.

Not established by the record: whether any patient was harmed, whether any product was found to be non-sterile through testing, whether the recall has since been terminated or completed, and whether any litigation, claim, or court proceeding exists in connection with this product. A recall record documents a firm’s action and FDA’s classification of it, not a finding of fault or liability.

Where the claims stand procedurally

The available record documents an FDA enforcement action only. The recall is identified by number D-0024-2027 in FDA’s openFDA enforcement dataset, which lists a single matching result for that number. As of the October 21, 2026 dataset update, the entry shows a status of Ongoing.

No federal court consolidation, multidistrict litigation, class action, or other proceeding concerning this Tri-MIX product appears in the sources reviewed for this article. A multidistrict litigation (MDL) is a procedure in which federal civil cases sharing common facts are transferred to one judge for coordinated pretrial proceedings. Nothing in these documents indicates that such a step has been taken here, and the absence of a court record is not evidence that no claim has been filed.

For background on how FDA recall records and pharmaceutical litigation records differ in what they show, see the site’s accounts of the American Health Packaging metoclopramide recall and the J&J Innovative Medicine Imaavy recall.

Key dates

• September 10, 2026: Carolina Infusion, LLC initiated the voluntary recall (recall initiation date).
• September 18, 2026: Beyond-use date (BUD) listed for Lot 08042026@8.
• October 8, 2026: FDA center classification date for recall D-0024-2027.
• October 14, 2026: FDA report date for the recall entry.
• October 21, 2026: openFDA enforcement dataset last updated, listing the recall as Ongoing.

What this does not establish

The record does not show that any recalled syringe was contaminated. The stated reason is a lack of assurance of sterility tied to processing equipment, not a confirmed contamination finding.

The record does not identify any injury, illness, or adverse event, and it names no patient. Patient-specific syringe dosing appears in the product description as a dispensing detail, not as patient information.

The record does not show that the recall has been completed or terminated. FDA’s drug recall page explains that recalls not indicated as terminated are either ongoing or completed, and the openFDA entry lists this one as Ongoing.

The record does not show any court ruling, verdict, settlement, or filed lawsuit connected to this product. It also does not show whether FDA took any action beyond classifying the recall.

Frequently asked questions

What product did Carolina Infusion, LLC recall?

Carolina Infusion, LLC recalled Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, an injectable compounded product packaged in single-use dosage syringes. The recalled quantity is listed as 3 ML in a patient-specific syringe dose under Lot 08042026@8, with a beyond-use date of 9/18/2026. The product was distributed nationwide within the United States.

Why was the Tri-MIX product recalled?

FDA’s enforcement record states the reason as “Lack of Assurance of Sterility: Related to processing equipment used in compounded product.” The concern relates to equipment used in processing the compounded product. The record does not state that testing confirmed contamination in any syringe.

What does Class II mean for recall D-0024-2027?

FDA classified recall D-0024-2027 as Class II. FDA’s drug recall page describes a recall as a voluntary action to remove a defective drug from the market or warn about a potential risk, and it uses classification categories without further defining Class II on that page. The classification is FDA’s hazard designation for the recall, not a court finding.

Is there a lawsuit or MDL about the Carolina Infusion Tri-MIX recall?

No lawsuit, MDL, or other court proceeding concerning this Tri-MIX product appears in the sources reviewed. The available record documents only the FDA enforcement action, recall number D-0024-2027, which openFDA lists as Ongoing as of October 21, 2026. The absence of a court record does not by itself show that no claim has been filed.

What is the current status of the recall?

The openFDA enforcement dataset, last updated October 21, 2026, lists recall D-0024-2027 with a status of Ongoing. FDA’s drug recall page explains that recalls not marked as terminated are either ongoing or completed. The record reviewed does not show a termination entry for this recall.

Sources

1. U.S. Food and Drug Administration (openFDA): “Drug Enforcement Report, recall number D-0024-2027” (link, accessed 2026-10-30)
2. U.S. Food and Drug Administration: “Drug Recalls” (link, accessed 2026-10-30)
3. U.S. Food and Drug Administration: “Drug Safety Communications” (link, accessed 2026-10-30)
4. U.S. Food and Drug Administration: “Drugs@FDA Data Files” (link, accessed 2026-10-30)
5. U.S. Food and Drug Administration: “What’s New: Drugs RSS Feed” (link, accessed 2026-10-30)
6. U.S. Food and Drug Administration: “Drug Safety and Availability” (link, accessed 2026-10-30)