Irbesartan

Irbesartan recalls: 7 FDA reports

Recalls involving Irbesartan. What was wrong with each batch, and how the FDA graded the risk.

7Reports
0Class I
1Ongoing
2025-02-19Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II7

By year reported

YearReports
20191
20213
20222
20251
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, T

D-0224-2025  ·  Class II  ·  reported 2025-02-19  ·  Ongoing

Why it was recalled
Out of Specification for Dissolution
Product
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Where it went
Nationwide in the USA
How much
341 cartons

Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 24

D-1294-2022  ·  Class II  ·  reported 2022-08-03  ·  Terminated

Why it was recalled
Failed Dissolution Specifications
Product
Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90
Where it went
Nationwide within the United States
How much
28,560 bottles

Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 2

D-1293-2022  ·  Class II  ·  reported 2022-08-03  ·  Terminated

Why it was recalled
Failed dissolution specifications.
Product
Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90
Where it went
Nationwide within the United States
How much
9,600 bottles

Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx

D-0087-2022  ·  Class II  ·  reported 2021-11-10  ·  Terminated

Why it was recalled
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Product
Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
Where it went
Product was distributed to major distributors who may have further distributed the product nationwide.
How much
134,016 bottles

Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx

D-0088-2022  ·  Class II  ·  reported 2021-11-10  ·  Terminated

Why it was recalled
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Product
Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
Where it went
Product was distributed to major distributors who may have further distributed the product nationwide.
How much
119,544 bottles

Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx o

D-0086-2022  ·  Class II  ·  reported 2021-11-10  ·  Terminated

Why it was recalled
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Product
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 went
Product was distributed to major distributors who may have further distributed the product nationwide.
How much
51,144 bottles

Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, L

D-0409-2019  ·  Class II  ·  reported 2019-02-06  ·  Completed

Why it was recalled
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Product
Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09
Where it went
Nationwide
How much
19800 bottles
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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