FDA Recall D-0120-2026
ProRx LLC · Exton, PA
Class II Ongoing 211 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03
Reason for recall
Lack of Assurance of Sterility
Recall record
- Recall number
D-0120-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- TX and UT
- Recall initiated
- 2025-10-15
- Classified by FDA Center
- 2025-10-27
- FDA published
- 2025-11-05
- Recalling firm
- ProRx LLC
- Firm location
- Exton, PA
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.