CLASS II Drug recall · Reported 30 Aug 2023 · FDA Enforcement Report
Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials recalled
TMC Acquisitions is recalling Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding, distributed nationwide in the US. The recall was initiated on 15 Aug 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1105-2023
- FDA event ID
- 92896
- Recalling firm
- TMC Acquisitions, Nicholasville, KY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Aug 2023
- FDA classified
- 24 Aug 2023
- Reported
- 30 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Diabetes Medication
Timeline
| 15 Aug 2023 | Recall initiated by company | |
| 24 Aug 2023 | Classified by FDA | +9 days |
| 30 Aug 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.
Where it was distributed
Nationwide within the USA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot#: 07262326A1, BUD: 10/24/2023
Where was it sold?
Nationwide within the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 92896| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | NAD+ 200mg/ml vials, Tailor Made Compounding recalled | TMC Acquisitions | Sterility | Nationwide |
More recalls from TMC Acquisitions
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | NAD+ 200mg/ml vials, Tailor Made Compounding recalled | TMC Acquisitions | Sterility | Nationwide |
Other Semaglutide recalls
All 38| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Semaglutide 5mg (1mg/mL), Glycine 25 mg recalled by Apollo Care | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 4.5mg (0.9 mg/mL) Sterile Multi-Dose Vial recalled | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 9mg (4.5 mg/mL) Sterile Multi-Dose Vial recalled | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 10mg (5mg/mL), Glycine 10 mg recalled by Apollo Care | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 20mg (5mg/mL), Glycine 20 mg recalled by Apollo Care | Apollo Care | Particulate Matter | Nationwide |