Recall alert: Lupin Pharmaceuticals recalls irbesartan

Lupin Pharmaceuticals and the Food and Drug Administration have announced a recall of batches of irbesartan tablets and irbesartan hydrochlorothiazide tablets, used to treat high blood pressure.

Some batches of the drugs had higher than the approved limit of N-nitrosoirbesartan, “a probable human carcinogen.”

The higher than acceptable levels were found in batches of unfinished medication, the FDA said.

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The medication was shipped starting Oct. 18, 2018, through Sept. 30, 2021.

Lupin has received four reports of illnesses from irbesartan use, but none from the irbesartan hydrochlorothiazide medication.

The following batches of irbesartan tablets are being recalled:

ProductLot No.NDCDistribution dates
Irbesartan Tablets USP, 75mgH000843, H805727, H90157968180-410-06 (30’s10/20/2018

H000844, H000964, H804311,
H805267, H805268, H805269,
H805725, H805726, H901497,
H901577, H901578, H902258
68180-410-09 (90’s10/20/2018

Irbesartan Tablets USP, 150mgH804403, H805251, H805640,
68180-411-06 (30’s10/20/2018

H804492, H805252, H805253,
H805641, H805642, H805643,
H901581, H902139, H902140
68180-411-09 (90’s10/20/2018

Irbesartan Tablets USP, 300mgH804310, H900050, H90226268180-412-06 (30’s10/20/2018

H000845, H000846, H000965,
H805345, H805346, H805347,
H805724, H900061, H900062,
H900445, H901489, H901490,
H901491, H902261
68180-412-09 (90’s10/20/2018


The following batches of irbesartan and hydrochlorothiazide tablets are being recalled:

ProductLot No.NCDDistribution Dates
Irbesartan and
Hydrochlorothiazide Tablets USP,
H804537, H805148,
H900063, H900522,
68180-413-06 (30’s10/17/2018

H000963, H804507,
H804536, H805070,
H805149, H900064,
H900523, H901583,
68180-413-09 (90’s10/17/2018

Irbesartan and
Hydrochlorothiazide Tablets USP,
H804192, H805348,
H900065, H902264
68180-414-06 (30’s10/17/2018

H804082, H804121,
H804338, H804538,
H804539, H805349,
H805350, H900066,
H900067, H902265,
H902275, H902276,
H902531, H902532
68180-414-09 (90’s10/17/2018


Patients who are prescribed the medication are being advised to continue taking it, but to contact their pharmacy, doctor or other medical provider for an alternative treatment.

If you have questions, you can call Inmar Rx Solutions at 855-769-3988 or 855-769-3989, Monday through Friday 9 a.m. to 5 p.m. EST.

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