FDA Recalls Tri-MIX Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tri-MIX injectable syringes due to a lack of assurance of sterility related to processing equipment.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II due to a lack of assurance of sterility in an injectable product. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Carolina Infusion, LLC is voluntarily recalling specific lots of Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/20, injectable. The product is packaged in single-use dosage syringes and was distributed nationwide within the U.S. The recall involves lots 08072026@2 and 08032026@10.
The recall was initiated due to a lack of assurance of sterility related to the processing equipment used in the compounded product. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Patients who have received this medication should contact their healthcare provider for guidance. The FDA has classified this recall as Class II.
The recalled product
- 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,
- Manufacturer
- Carolina Infusion, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 15
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 (4)
- Lot: 08072026@2
- BUD:9/21/2026
- 08032026@10
- BUD:09/17/2026.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Carolina Infusion, LLC
See all →- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereCarolina Infusion Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereCarolina Infusion Recalls Semaglutide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Syringes Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-10-14
Same hazard · sterility
See all →- SevereK.C. Pharmaceuticals Recalls Artificial Tears Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereCarolina Infusion Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Ultra Lubricating Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereApothecary Pharma Recalls Tirzepatide Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereGood Sense Eye Drops Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereCarolina Infusion Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Syringes Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-10-14
- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- HighInjectable drug recalled due to lack of sterility assurance
FDA (Drugs) · 2022-09-21
- HighTRI-MIX 30/1/20 Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-09-21