CLASS III Drug recall · Reported 29 Jun 2016 · FDA Enforcement Report
Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg recalled
Prinston Pharmaceutical is recalling Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, distributed nationwide in the US. The recall was initiated on 30 May 2016 and the FDA has classified it as Class III.
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-1049-2016
- FDA event ID
- 74423
- Recalling firm
- Prinston Pharmaceutical, Cranbury, NJ
- Manufacturer
- Solco Healthcare US, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 30 May 2016
- FDA classified
- 23 Jun 2016
- Reported
- 29 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 30 May 2016 | Recall initiated by company | |
| 23 Jun 2016 | Classified by FDA | +24 days |
| 29 Jun 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.
Product as listed by the FDA
Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare U.S., LLC, Cranbury, NJ 08512, NDC 43547-331-09.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.
Which lots are affected?
Lot #: 327B16002, Exp 12/17
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 12 Oct 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 Tablets 300 mg recalled by Prinston PharmaceuticalIrbesartan | 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 |
Other Irbesartan recalls
All 20| 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 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 |