Compounded Semaglutide Recalled Due to Lack of Sterility Assurance
ProRx LLC is recalling 1,960 vials of compounded semaglutide nationwide due to lack of assurance of sterility. The multiple-dose vials may not meet sterility standards for injectable medications.
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: FDA Class II classification indicates potential for serious health consequence, but the source reports no illnesses or injuries. The hazard is theoretical—lack of assured sterility in an injectable medication represents a risk of harm to patients, but without documented adverse events, this meets the threshold for High severity rather than Severe.
Plain-English summary
ProRx LLC is recalling 1,960 vials of compounded semaglutide (10mg/4mL, lot ProRx061424, BUD 12/13/2024) distributed nationwide in the USA. The recall concerns prescription-only compounded injectable vials.
The recall is due to lack of assurance of sterility. These multiple-dose vials may not meet the strict sterility standards required for compounded injectable medications, which could put patients at risk of infection.
Patients who received vials from this lot should contact their healthcare provider immediately. Healthcare providers and dispensing facilities should check their records for NDC 84139-225-04 with lot code ProRx061424 and expiration date 12/13/2024, remove affected vials from use, and notify patients.
The recalled product
- Product
- SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
- Manufacturer
- ProRx LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 1,960
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)
- ProRx061424
- BUD 12/13/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by ProRx 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 7 products in this recall →Related recalls
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