Irbesartan Tablets USP recall: Failed Dissolution
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Why was Irbesartan Tablets USP recalled?
Out of Specification for Dissolution
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 45279, Exp 03/31/2025
- 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
- Recalling firm
- AvKARE
- Quantity
- 341 cartons
- Distribution
- Nationwide in the USA
- Recall date
- February 19, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)