FDA Recall D-0224-2025
AvKARE · Pulaski, TN
Class II Ongoing 478 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Reason for recall
Out of Specification for Dissolution
Recall record
- Recall number
D-0224-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2025-01-21
- Classified by FDA Center
- 2025-02-11
- FDA published
- 2025-02-19
- Recalling firm
- AvKARE
- Firm location
- Pulaski, TN
Drug identification
- Brand name(s)
- IRBESARTAN
- Generic name(s)
- IRBESARTAN
- Manufacturer(s)
- AvPAK
- NDC(s)
50268-441, 50268-440, 50268-442- Route(s)
- ORAL
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.