Compounded Semaglutide/Cyanocobalamin Vials Recalled for Sterility Concerns
Tailor Made Compounding is recalling 9 vials of Semaglutide/Cyanocobalamin 2mg/0.4mg/mL due to inability to assure sterility. The product was distributed nationwide.
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 an FDA Class II recall of an injectable drug where sterility assurance cannot be verified. As a risk-of-harm injectable product with no reported illnesses or injuries, it meets the rubric criterion for High (3) severity.
Plain-English summary
Tailor Made Compounding is recalling Semaglutide/Cyanocobalamin 2mg/0.4mg/mL injectable vials due to a lack of assurance of sterility. The recall affects 9 vials of this compounded injectable medication (Lot #07262326A1, BUD 10/24/2023) that were distributed nationwide.
When the sterility of an injectable product cannot be assured, there is a potential risk of bacterial or fungal contamination. Such contamination could cause serious infections or other adverse health effects if the product is administered.
Consumers who have received this product should contact their healthcare provider immediately. Do not use remaining vials from the affected lot. Healthcare providers and pharmacies should quarantine any remaining vials and contact Tailor Made Compounding for return and destruction instructions.
The recalled product
- Product
- Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.
- Manufacturer
- TMC Acquisitions LLC dba Tailor Made Compounding
- Category
- Drug — Injectable / Compounded
- Affected units
- 9
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 (2)
- Lot#: 07262326A1
- BUD: 10/24/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by TMC Acquisitions 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 2 products in this recall →Related recalls
Same manufacturer · TMC Acquisitions LLC dba Tailor Made Compounding
See all →- HighNAD+ Injectable Vials Recalled for Sterility Assurance Deficiency
FDA (Drugs) · 2023-08-30
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighCompounded Semaglutide/Cyanocobalamin Vials Recalled Over Sterility Concerns
FDA (Drugs) · 2022-07-20
- HighSemaglutide/Cyanocobalamin Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
- HighInjectable Methylcobalamin recalled due to lack of sterility assurance
FDA (Drugs) · 2022-07-20
- HighHydroxocobalamin Compounded Injections Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
- HighProRx Compounded Semaglutide/Cyanocobalamin Injection Recalled Due to Sterility Assurance Issues
FDA (Drugs) · 2024-09-11
- HighMethylcobalamin Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20