CLASS II Drug recall · Reported 10 Nov 2021 · FDA Enforcement Report
Irbesartan Tablets USP, 75 mg a) recalled by Lupin Pharmaceuticals
Lupin Pharmaceuticals is recalling Irbesartan Tablets USP, 75 mg a) (, distributed nationwide in the US. The recall was initiated on 12 Oct 2021 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-0086-2022
- FDA event ID
- 88856
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Irbesartan
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Oct 2021
- FDA classified
- 1 Nov 2021
- Reported
- 10 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 12 Oct 2021 | Recall initiated by company | |
| 1 Nov 2021 | Classified by FDA | +20 days |
| 10 Nov 2021 | Published in enforcement report | +9 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: impurity N-nitrosoirbesartan detected in API
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 USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
Where it was distributed
Product was distributed to major distributors who may have further distributed the product nationwide.
Questions about this recall
Why was it recalled?
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Which lots are affected?
a) Lot# H000843, exp. date 28/02/2023 H805727, exp. date 30/11/2021 H901579, exp. date 31/03/2022 b) Lot# H000844, exp. date 28/02/2023 H000964, exp. date 31/03/2023 H804311, exp. date 31/08/2021 H805267, exp. date 30/11/2021 H805268, exp. date 30/11/2021 H805269, exp. date 30/11/2021 H805725, exp. date 30/11/2021 H805726, exp. date 30/11/2021 H901497, exp. date 31/01/2022 H901577, exp. date 31/03/2022 H901578, exp. date 31/03/2022 H902258, exp. date 31/05/2022
Where was it sold?
Product was distributed to major distributors who may have further distributed the product 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
4 other products · FDA event 88856This product is part of a recall event; the main page for the event is Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) recalled | Lupin Pharmaceuticals | Nitrosamine Impurity | Nationwide | |
| CLASS II | Irbesartan Tablets USP, 150 mg a) recalled by Lupin PharmaceuticalsIrbesartan | Lupin Pharmaceuticals | Nitrosamine Impurity | Nationwide | |
| CLASS II | Irbesartan Tablets USP, 300 mg a) recalled by Lupin PharmaceuticalsIrbesartan | Lupin Pharmaceuticals | Nitrosamine Impurity | Nationwide | |
| CLASS II | Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) recalled | Lupin Pharmaceuticals | Nitrosamine Impurity | Nationwide |
More recalls from Lupin Pharmaceuticals
All 123| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | prednisoLONE Acetate Ophthalmic Suspension recalledPrednisolone Acetate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Glucagon Emergency Kit for Low Blood Sugar, Glucagon recalledGlucagon | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Liraglutide Injection, 18 mg/ (6 mg/mL) recalledLiraglutide | Lupin Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Sertraline Hydrochloride Tablets USP, 100 mg recalledSertraline Hydrochloride | Lupin Pharmaceuticals | Packaging Defects | 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, 300 mg a) recalled by Lupin PharmaceuticalsIrbesartan | Lupin Pharmaceuticals | Nitrosamine Impurity | Nationwide |