Agency classClass IIOur severity:Severe FDA (Drugs)·D-0017-2027·Announced 2026-10-14

FDA Recalls Tirzepatide Injectable Due to Sterility Concerns

Carolina Infusion, LLC is recalling Tirzepatide 26 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and 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, and the source does not report any illnesses, injuries, or deaths.

Plain-English summary

Carolina Infusion, LLC is recalling Tirzepatide 26 mg/mL injectable, packaged in single-use dosage syringes. The recall is due to a lack of assurance of sterility, which is related to the formulation using bacteriostic water and the processing equipment used in the compounded product.

The affected product was distributed nationwide within the U.S. The specific lots involved are 09012026@3, 08032026@16, 08052026@8, and 08072026@13. The source text does not report any illnesses, injuries, or deaths associated with this recall.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product: 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;
Manufacturer: Carolina Infusion, LLC
Category: Drug — Injectable
Hazard: sterility

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 (8)

Lots: 09012026@3
BUD: 10/16/2026
08032026@16
BUD: 9/17/2026
08052026@8
BUD: 9/19/2026
08072026@13
BUD: 9/21/2026.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Carolina Infusion, LLC

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Same hazard · sterility