CLASS II Drug recall · Reported 19 Dec 2018 · FDA Enforcement Report
Westminster Irbesartan Tablets, USP 150 mg recalled
Westminster Pharmaceuticals is recalling Westminster Irbesartan Tablets, USP 150 mg, distributed nationwide in the US. The recall was initiated on 29 Oct 2018 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-0301-2019
- FDA event ID
- 81668
- Recalling firm
- Westminster Pharmaceuticals, Olive Branch, MS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Oct 2018
- FDA classified
- 14 Dec 2018
- Reported
- 19 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 29 Oct 2018 | Recall initiated by company | |
| 14 Dec 2018 | Classified by FDA | +46 days |
| 19 Dec 2018 | Published in enforcement report | +5 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 laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
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
Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-120-01; b) 90 count bottle NDC 69367-120-03
Where it was distributed
Nationwide.
Questions about this recall
Is Westminster Irbesartan Tablets, USP 150 mg recalled?
Yes. Westminster Pharmaceuticals recalled Westminster Irbesartan Tablets, USP 150 mg on 29 Oct 2018. The recall is Class II and its status is Terminated. Recall number D-0301-2019.
Why was it recalled?
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Which lots are affected?
Batch Numbers: a) B161005A Exp. 09/30/2019, C161002A Exp. 02/29/2020; b) B161005B Exp. 09/30/2019, C161002B Exp. 02/29/2020
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 Westminster Pharmaceuticals
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metoprolol Tartrate Tablets, USP, 50 mg recalled | Westminster Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Metoprolol Tartrate Tablets, USP, 100 mg recalled | Westminster Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Westminster Irbesartan Tablets, USP 300 mg recalled | Westminster Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Westminster Irbesartan Tablets, USP 75 mg recalled | Westminster Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS I | Levothyroxine and Liothyronine (Thyroid Tablets, USP) recalled | Westminster Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
Other Westminster irbesartan recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Westminster Irbesartan Tablets, USP 300 mg recalled | Westminster Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Westminster Irbesartan Tablets, USP 75 mg recalled | Westminster Pharmaceuticals | Nitrosamine Impurity | Nationwide |