Compounded semaglutide injection recalled after testing subpotent in three lots
Semaglutide 2.5 mg/mL injection, 4 mL, from Boothwyn Pharmacy is recalled nationwide as a subpotent drug. 648 vials are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a subpotent injectable medicine may not deliver the intended dose and no injuries are reported.
Plain-English summary
Semaglutide, 2.5 mg/mL injection, 4 mL, from Boothwyn Pharmacy is being recalled. The affected product carries codes 03202025@2, 03202025@3 and 03202025@4, with a beyond-use date of 07/18/2025. The recall covers 648 vials distributed nationwide.
The recall was issued because the product is subpotent. The FDA classified the action as Class II.
Patients should check the code on their vial against the recall and speak to their prescriber or pharmacy about a replacement supply before stopping a prescribed treatment.
The recalled product
- Product
- Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy
- Manufacturer
- Boothwyn Pharmacy LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 648
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)
- 03202025@2
- 03202025@3 and 03202025@4 BUD 07/18/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Boothwyn Pharmacy LLC 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 4 products in this recall →Related recalls
Same manufacturer · Boothwyn Pharmacy LLC
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