FDAClass IIRecall started September 10, 2026

Tri-MIX,30/1/20 Recall: Sterility Concern

Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936,

What is the FDA recall status?

The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.

How FDA enforcement data reports status

Why was Tri-MIX,30/1/20 recalled?

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Which lot codes, UPCs or models are affected?

Lot: 08072026@2, BUD:9/21/2026; 08032026@10, BUD:09/17/2026.

Agency record number
D-0022-2027
Product
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936,
Recalling firm
Carolina Infusion, LLC
Quantity
15 mLs - in patient specific syringe doses
Distribution
Nationwide within the U.S
Recall started
September 10, 2026
Report date
October 14, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls