CLASS II ONGOING Drug recall · Reported 13 Aug 2025 · FDA Enforcement Report
Semaglutide + Cyanocobalamin 44 mg + 25mg/ Inj Sol recalled
Aequita Pharmacy is recalling Semaglutide + Cyanocobalamin 44 mg + 25mg/ Inj Sol, Inject on syringe) subcutaneously, distributed in Massachusetts. The recall was initiated on 18 Jul 2025 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-0561-2025
- FDA event ID
- 97292
- Recalling firm
- Aequita Pharmacy, Kirkland, WA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Jul 2025
- FDA classified
- 1 Aug 2025
- Reported
- 13 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Diabetes Medication
Timeline
| 18 Jul 2025 | Recall initiated by company | |
| 1 Aug 2025 | Classified by FDA | +14 days |
| 13 Aug 2025 | Published in enforcement report | +12 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 Processing Controls.
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 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Where it was distributed
MA
Stores named: Costco
Questions about this recall
Is Semaglutide + Cyanocobalamin 44 mg + 25mg/ Inj Sol, Inject on syringe) subcutaneously recalled?
Yes. Aequita Pharmacy recalled Semaglutide + Cyanocobalamin 44 mg + 25mg/ Inj Sol, Inject on syringe) subcutaneously on 18 Jul 2025. The recall is Class II and its status is Ongoing. Recall number D-0561-2025.
Why was it recalled?
Lack of Processing Controls.
Which lots are affected?
All Lots within expiry.
Where was it sold?
MA
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aequita Pharmacy
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tirzepatide + Niacinamide 2 mg + 0mg/ Inj Sol recalled | Aequita Pharmacy | Sterility | MA |
| Drug | CLASS II | Tirzepatide + Niacinamide 8 mg + 0mg/ Inj Sol recalled | Aequita Pharmacy | Sterility | MA |
| Drug | CLASS II | Semaglutide + Cyanocobalamin 67 mg + 25mg/ Inj Sol recalled | Aequita Pharmacy | Sterility | MA |
| Drug | CLASS II | Tirzepatide + Niacinamide 6 mg + 0mg/ Inj Sol recalled | Aequita Pharmacy | Sterility | MA |
| Drug | CLASS II | Tirzepatide + Niacinamide 6 mg + 0mg/ Inj Sol recalled | Aequita Pharmacy | Sterility | MA |