CLASS II ONGOING Drug recall · Reported 19 Feb 2025 · FDA Enforcement Report
Irbesartan Tablets USP, 300 mg Dose recalled by AvKARE
AvKARE is recalling Irbesartan Tablets USP, 300 mg Dose per, distributed nationwide in the US. The recall was initiated on 21 Jan 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0224-2025
- FDA event ID
- 96172
- Recalling firm
- AvKARE, Pulaski, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Jan 2025
- FDA classified
- 11 Feb 2025
- Reported
- 19 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 21 Jan 2025 | Recall initiated by company | |
| 11 Feb 2025 | Classified by FDA | +21 days |
| 19 Feb 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out of Specification for Dissolution
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Out of Specification for Dissolution
Which lots are affected?
Lot 45279, Exp 03/31/2025
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from AvKARE
All 62| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Norgestimate and Ethinyl Estradiol Tablets recalled by AvKARENorgestimate And Ethinyl Estradiol | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 50 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
Other Irbesartan recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Irbesartan Tablets, USP, 150mg recalled by Jubilant CadistaIrbesartan | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irbesartan Tablets, USP, 75 mg recalled by Jubilant CadistaIrbesartan | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) recalled | Lupin Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Irbesartan Tablets USP, 75 mg a) recalled by Lupin PharmaceuticalsIrbesartan | Lupin Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Irbesartan Tablets USP, 300 mg a) recalled by Lupin PharmaceuticalsIrbesartan | Lupin Pharmaceuticals | Nitrosamine Impurity | Nationwide |