Blood Pressure Drugs Recalled Over Impurity

Lupin Pharmaceuticals Inc is recalling dozens of lots of irbesartan products because of the potential of an N-nitrosoirbesartan impurity. The recalls are included in the November 10, 2021, US Food and Drug Administration (FDA) Enforcement Report.

“As part of Lupin’s ongoing assessment, analysis revealed that certain tested API [active pharmaceutical ingredient] batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan,” Lupin Pharmaceuticals stated in an October 14, 2021, company announcement. “Although Lupin has received no reports of illness that appear to relate to this issue, the company, out of an abundance of caution, is recalling all batches of Irbesartan Tablets USP 75 mg, 150 mg and 300 mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150 mg/12.5 mg and 300 mg/12.5 mg in the US.”

N-nitrosoirbesartan is a probable human carcinogen, the statement explained.

The following products, which were distributed throughout the United States to wholesalers, drug store chains, mail order pharmacies, and supermarkets, are affected by the recall:

• irbesartan tablets, 75 mg, in 30-count bottles (NDC 68180-410-06) from lots H000843 (Exp. 2/28/23), H805727 (Exp. 11/30/21), and H901579 (Exp. 3/31/22);
• irbesartan tablets, 75 mg, in 90-count bottles (NDC 68180-410-09) from lots H000844 (Exp. 2/2823), H000964 (Exp.3/31/23), H804311 (Exp. 8/31/21), H805267 (Exp. 11/30/21), H805268 (Exp. 11/30/21), H805269 (Exp. 11/30/21), H805725 (Exp. 11/30/21), H805726 (Exp. 11/30/21), H901497 (Exp. 1/31/22), H901577 (Exp. 3/31/22), H901578 (Exp. 3/31/22), and H902258 (Exp. date 5/31/22);
• irbesartan tablets, 150 mg, in 30-count bottles (NDC 68180-411-06) from lots H804403 (Exp. 8/31/21), H805251 (Exp. 11/30/21), H805640 (Exp. 11/30/21), and H901580 (Exp. 4/30/22);
• irbesartan tablets, 150 mg, in 90-count bottles (NDC 68180-411-09) from lots H804492 (Exp. 8/31/21), H805252 (Exp. 11/30/21), H805253 (Exp. 11/30/21), H805641 (Exp. 11/30/21), H805642 (Exp. 11/30/21), H805643 (Exp. 11/30/21), H901581 (Exp. 4/30/21) H902139 (Exp. 4/30/22), and H902140 (Exp. 4/30/22);
• irbesartan tablets, 300 mg, in 30-count bottles (NDC 68180-412-06) from lots H804310 (Exp. 8/31/21), H900050 (Exp. 11/30/21), and H902262 (Exp. 31/05/22);
• irbesartan tablets, 300 mg, in 90-count bottles (NDC 68180-412-09) from lots H000845 (Exp. 2/28/23), H000846 (Exp. 2/28/23), H000965 (Exp. 3/31/23), H805345 (Exp. 11/30/21), H805346 (Exp. 11/30/21), H805347 (Exp. 11/30/21), H805724 (Exp. 11/30/21), H900061 (Exp. 12/31/21), H900062 (Exp. 12/31/21), H900445 (Exp. 1/31/22), H901489 (Exp. 3/31/22), H901490 (Exp. 3/31/22), H901491 (Exp. 3/31/22), and H902261 (Exp. 5/31/22);
• irbesartan and hydrochlorothiazide tablets, 150 mg/12.5 mg, in 30-count bottles (NDC 68180-413-06) from lots H804537 (Exp. 9/30/21), H805148 (Exp. 10/31/21), H900063 (Exp. 10/31/21), H900522 (Exp. 12/31/21), and H901582 (Exp. 1/31/22);
• irbesartan and hydrochlorothiazide tablets, 150 mg/12.5 mg, in 90-count bottles (NDC 68180-413-09) from lots H000963 (Exp. 4/30/22), H804507 (Exp. 4/30/22), H804536 (Exp. 9/30/21), H805070 (Exp. 10/31/21), H805149 (Exp. 10/31/21), H900064 (Exp. 12/31/21), H900523 (Exp. 1/31/22), H901583 (Exp. 4/30/22), and H902530 (Exp. 4/30/22);
• irbesartan and hydrochlorothiazide tablets, 300 mg/12.5 mg, in 30-count bottles (NDC 68180-414-06) from lots H804192 (Exp. 8/31/21), H805348 (Exp. 11/30/21), H900065 (Exp. 12/31/21), and H902264 (Exp. 5/31/22); and
• irbesartan and hydrochlorothiazide tablets, 300 mg/12.5 mg, in 90-count bottles (NDC 68180-414-09) from lots H804082 (Exp. 8/31/21), H804121 (Exp. 8/31/21), H804338 (Exp. 8/31/21), H804538 (Exp. 9/30/21), H804539 (Exp. 9/30/21), H805349 (Exp. 11/30/21), H805350 (Exp. 11/30/21), H900066 (Exp. 12/31/21), H900067 (Exp. 12/31/21), H902265 (Exp. 5/31/22), H902275 (Exp. 5/31/22), H902276 (Exp. 5/31/22), H902531 (Exp. 4/30/22), and H902532 (Exp. 4/30/22).

“From October 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches), to September 30, 2021, Lupin received four reports of illness from irbesartan and zero reports from irbesartan and hydrochlorothiazide,” the statement explained.

Lupin Pharmaceuticals voluntarily initiated the recall October 12, 2021. On November 1, 2021, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Irbesartan is prescription antihypertensive medication used to treat high blood pressure and diabetic nephropathy. Irbesartan and hydrochlorothiazide is a combination prescription medication also used to treat high blood pressure.