CLASS II Drug recall · Reported 28 Nov 2018 · FDA Enforcement Report
Westminister Irbesartan Tablets, USP, 75 mg (a) bottle recalled
Sciegen Pharmaceuticals is recalling Westminister Irbesartan Tablets, USP, 75 mg (a) bottle (, 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-0267-2019
- FDA event ID
- 81458
- Recalling firm
- Sciegen Pharmaceuticals, Hauppauge, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Oct 2018
- FDA classified
- 20 Nov 2018
- Reported
- 28 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 29 Oct 2018 | Recall initiated by company | |
| 20 Nov 2018 | Classified by FDA | +22 days |
| 28 Nov 2018 | 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
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
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
Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Which lots are affected?
69367-119-01 Irbesartan 75mg Tablets, 30 count bottle B160002A Sep-19 69367-119-03 Irbesartan 75mg Tablets, 90 count bottle B160002B Sep-19
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 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.
Other products in this recall event
5 other products · FDA event 81458More recalls from Sciegen Pharmaceuticals
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Gabapentin Tablets, USP 600 mg recalled by Sciegen PharmaceuticalsGabapentin | Sciegen Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Westminister Irbesartan Tablets, USP, 300mg recalled | Sciegen Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | GSMS Irbesartan Tablets, USP, 300 mg,(a) bottle recalled | Sciegen Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | GSMS Irbesartan Tablets, USP, 75 mg recalled by Sciegen Pharmaceuticals | Sciegen Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Westminister Irbesartan Tablets, USP, 150 mg, (a) bottle recalled | Sciegen Pharmaceuticals | Nitrosamine Impurity | Nationwide |
Other Westminister Irbesartan recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Westminister Irbesartan Tablets, USP, 300mg recalled | Sciegen Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Westminister Irbesartan Tablets, USP, 150 mg, (a) bottle recalled | Sciegen Pharmaceuticals | Nitrosamine Impurity | Nationwide |