Drug recall: TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per…
Class II FDA enforcement event 99867. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Class II, in the words of FDA
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
Carolina Infusion, LLC started this drug recall on 10 Sep 2026. The firm address in the FDA record is in Ridgeland, SC. FDA put the recall in Class II. FDA event 99867 has 16 product records. The first FDA enforcement report date is 14 Oct 2026. The record gives the status Ongoing. 4 of the 258 drug events that started in 2026 have more product records. The median drug event of 2026 has 1 product record.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide within the U.S
Recalling firm
Carolina Infusion, LLC, Ridgeland, SC.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
16 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0017-2027 | TIRZEPATIDE 26 MG/ML 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; | 5.6 mLs - in patient specific syringe doses | Class II | Ongoing | 14 Oct 2026 |
| D-0018-2027 | SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 | 8 x 0.1 ml syringes | Class II | Ongoing | 14 Oct 2026 |
| D-0019-2027 | SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML 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 | 57.0 mls - in patient specific syringe doses | Class II | Ongoing | 14 Oct 2026 |
| D-0020-2027 | SERMORELIN ACETATE 1 MG/ML 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 | 15 mls - in patient specific syringe doses | Class II | Ongoing | 14 Oct 2026 |
| D-0021-2027 | QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) 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 | 5 mls in patient specific syringe doses | Class II | Ongoing | 14 Oct 2026 |
| D-0022-2027 | 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, | 15 mLs - in patient specific syringe doses | Class II | Ongoing | 14 Oct 2026 |
| D-0023-2027 | Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, 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, | 5 mL in patient specific syringe doses | Class II | Ongoing | 14 Oct 2026 |
| D-0024-2027 | Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, 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 | 3 ML in patient specific syringe dose | Class II | Ongoing | 14 Oct 2026 |
| D-0025-2027 | Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, 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 | 5 mL in patient specific syringe dose | Class II | Ongoing | 14 Oct 2026 |
| D-0026-2027 | SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML 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 | 82.9 mls - in patient specific syringe dose | Class II | Ongoing | 14 Oct 2026 |
| D-0027-2027 | TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML 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 | 297 mL - in patient specific syringe dose | Class II | Ongoing | 14 Oct 2026 |
| D-0028-2027 | TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML 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 | 29.6 mls - in patient specific syringe dose | Class II | Ongoing | 14 Oct 2026 |
| D-0029-2027 | TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML 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 | 24.8 mLs -in patient specific syringe dose | Class II | Ongoing | 14 Oct 2026 |
| D-0030-2027 | TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML 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; | 30.4 mLs - in patient specific syringe dose | Class II | Ongoing | 14 Oct 2026 |
| D-0031-2027 | Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, 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 | 10 ml -in patient specific syringe dose | Class II | Ongoing | 14 Oct 2026 |
| D-0032-2027 | Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, 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 | 20 mLs - in patient specific syringe dose | Class II | Ongoing | 14 Oct 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2026
- 258
- Share of these events in Class II
- 75%
- Product records in this event
- 16
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-0017-2027The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 99867. https://recallregister.com/fda/ii/99867/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 27 Oct 2026
- Newest FDA report date on the register
- 21 Oct 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide within the U.S
- What quantity of product is in FDA event 99867?
- The event has 16 product records. The first record gives this quantity:
5.6 mLs - in patient specific syringe doses
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2026 have the same class?
- 75% of the 258 drug events that started in 2026 are in Class II.