The Recall Desk
HighFDA (Drugs)·D-0564-2025·Announced 2025-08-13

Compounded semaglutide 2.21 mg vials recalled over lack of processing controls

Semaglutide + Cyanocobalamin 2.21 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 176 vials are affected.

What this means for you

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: Risk-of-harm product: a sterile injectable compounded without adequate processing controls, with no infection or injury reported in the source.

Plain-English summary

Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25 mg per 0.5 mL, for subcutaneous injection, sterile, supplied in a 2 mL multi dose vial to be refrigerated and not frozen, compounded by Aequita Pharmacy LLC of Kirkland, Washington, is being recalled. The action covers 176 vials across all lots within expiry.

The stated reason is a lack of processing controls. The FDA classified the action as Class II. The source does not report any infection or injury.

Distribution was in Massachusetts.

Facilities and patients holding affected vials should stop using them and follow the instructions issued by the compounder.

The recalled product

Product
Semaglutide + Cyanocobalamin injection solution, 2.21 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.
Manufacturer
AEQUITA PHARMACY
Category
Drug — Compounded injectable
Hazard
  • processing-controls
  • compounded-drug
  • sterile-injectable
  • class-ii

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 (1)

  • All Lots within expiry.

Distribution

Distributed in 1 state:

  • MA

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