CLASS II Drug recall · Reported 28 Nov 2018 · FDA Enforcement Report
GSMS Irbesartan Tablets, USP, 150 mg, (a) bottle recalled
Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, USP, 150 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-0271-2019
- 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
GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
Where it was distributed
Nationwide
Questions about this recall
Is GSMS Irbesartan Tablets, USP, 150 mg, (a) bottle ( recalled?
Yes. Sciegen Pharmaceuticals recalled GSMS Irbesartan Tablets, USP, 150 mg, (a) bottle ( on 29 Oct 2018. The recall is Class II and its status is Terminated. Recall number D-0271-2019.
Why was it recalled?
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Which lots are affected?
60429-641-90 Irbesartan 150mg Tablets, 90 Count Bottle B161003 Sep-19 B161004 Sep-19 B161006 Sep-19 B161007 Sep-19 B161008 Nov-19 B161009 Nov-19 B161010 Nov-19 C161001 Feb-20 C161003 May-20 60429-641-30 Irbesartan 150mg Tablets, 30 Count Bottle GS019526 Nov-19 GS020252 Nov-19 GS020958 Nov-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 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 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 Gsms irbesartan recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |