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TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE Recall 2026

Carolina Infusion, LLCIssued September 10, 2026Updated Reviewed by the Recall Watch editorial team

Carolina Infusion, LLC 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 Roa — recalled per FDA on 9/10/2026. Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product..

Agency
FDA
Issued
Sep 10, 2026
Brand
Carolina Infusion, LLC
Distribution
1 states
Lots affected
6
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued September 10, 2026 · Last synced Oct 21, 2026

What's recalled

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

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Why it was recalled

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Affected products & lot numbers
6 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot:08032026@23
BUD: 9/17/2026
08172026@19
BUD: 10/1/2026
08262026@13
BUD: 10/10/2026.
Where was it sold
1 state

Nationwide within the U.S

nationwide
Official noticefda.gov
More recalls like this
8 related — by brand, contaminant, and category

Frequently asked questions

Is the Carolina Infusion, LLC recall still active?

Yes, this recall is currently active as of September 10, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot:08032026@23, BUD: 9/17/2026, 08172026@19, BUD: 10/1/2026, 08262026@13, BUD: 10/10/2026.. Check the label on your product.

What should I do if I have the recalled Carolina Infusion, LLC?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.