CLASS II Drug recall · Reported 6 Feb 2019 · FDA Enforcement Report
Irbesartan Tablets 300 mg recalled by Prinston Pharmaceutical
Prinston Pharmaceutical is recalling Irbesartan Tablets 300 mg, distributed nationwide in the US. The recall was initiated on 18 Jan 2019 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-0409-2019
- FDA event ID
- 81910
- Recalling firm
- Prinston Pharmaceutical, Somerset, NJ
- Brand
- Irbesartan
- Manufacturer
- Solco Healthcare U.S., LLC
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 18 Jan 2019
- FDA classified
- 27 Jan 2019
- Reported
- 6 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 18 Jan 2019 | Recall initiated by company | |
| 27 Jan 2019 | Classified by FDA | +9 days |
| 6 Feb 2019 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09
Where it was distributed
Nationwide
Questions about this recall
Is Irbesartan Tablets 300 mg recalled?
Yes. Prinston Pharmaceutical recalled Irbesartan Tablets 300 mg on 18 Jan 2019. The recall is Class II and its status is Completed. Recall number D-0409-2019.
Why was it recalled?
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Which lots are affected?
331B18009
Where was it sold?
Nationwide
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 21 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 Prinston Pharmaceutical
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg recalledIrbesartan And Hydrochlorothiazide | Prinston Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx Only recalledIrbesartan And Hydrochlorothiazide | Prinston Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg recalledIrbesartan And Hydrochlorothiazide | Prinston Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg recalledIrbesartan And Hydrochlorothiazide | Prinston Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12 recalledValsartan And Hydrochlorothiazide | Prinston Pharmaceutical | Potency & Assay | NJ |
Other Irbesartan recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Irbesartan Tablets USP, 300 mg Dose recalled by AvKARE | AvKARE | Potency & Assay | Nationwide |
| 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 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 |