Agency classClass IIOur severity:High FDA (Drugs)·D-1224-2022·Announced 2022-07-20

Semaglutide/Cyanocobalamin Injectable Recalled for Lack of Sterility Assurance

Tailor Made Compounding is recalling 5,842 vials of compounded semaglutide/cyanocobalamin injectable due to lack of sterility assurance. The product was distributed nationwide in the United States and Puerto Rico.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm product—an injectable medication that requires sterile manufacturing conditions. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not been reported are classified as High (score 3).

Plain-English summary

Tailor Made Compounding is recalling 5,842 vials of semaglutide/cyanocobalamin 2mg/0.4mg per milliliter in 1-milliliter vials. Multiple batch numbers are affected, with expiration dates ranging from March through June 2022.

The recall was issued due to lack of assurance of sterility. The manufacturer could not provide adequate verification that the product was manufactured under the required sterile conditions for injectable medications.

The affected product was distributed nationwide throughout the United States and Puerto Rico. Healthcare providers and patients who have received this product should be aware of the recall and verify which batch numbers they possess.

Patients and healthcare providers should contact their healthcare provider regarding any product they may have received. Do not use any remaining product from affected batches.

The recalled product

Product: Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding
Manufacturer: TMC Acquisition LLC dba Tailor Made Compounding
Category: Drug — Injectable / Compounded
Hazard: lack-of-sterility
contamination-risk
Affected units: 5,842

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 (20)

Batch#: 12032123A2
Exp 3/3/2022
12102101A2
Exp 3/10/2022
12202105A2
Exp 3/20/2022
12292106A2
Exp 3/29/2022
01062218B
Exp 4/6/2022
01192228A2
Exp 4/19/2022
01312214A2
Exp 5/1/2022
02012211A1
Exp 5/2/2022
02182201A1
02182203A1
Exp 5/19/2022
02242205A1

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 52 recalled by TMC Acquisition LLC dba Tailor Made Compounding under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 52 products in this recall →

Same manufacturer · TMC Acquisition LLC dba Tailor Made Compounding

See all →

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Dexpanthenol Preservative Free Injectable Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-07-20
High
Hydroxocobalamin Compounded Injections Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
High
Tailor Made Compounding Recalls Glycyrrhizic Acid Injectable for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
High
FDA Recalls Tailor Made Compounding GAC Injectable Vials for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
High
Estradiol Cypionate Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20

Same hazard · lack of sterility