Medications & Supplements/Prescription Drugs

Lupin Irbesartan Blood Pressure Medications Recalled for Chemical Impurity

Agency Publication Date: November 1, 2021

Summary

Lupin Pharmaceuticals Inc. is recalling 466,164 bottles of Irbesartan Tablets and Irbesartan/Hydrochlorothiazide Tablets used to treat high blood pressure. The recall was issued after tests revealed the presence of a chemical impurity called N-nitrosoirbesartan in the active drug ingredient. This substance is considered a probable human carcinogen based on results from laboratory tests. No incidents or injuries have been reported to date regarding this recall.

Risk

Long-term consumption of the medication containing N-nitrosoirbesartan above acceptable levels may increase the risk of developing cancer. This is a chemical impurity that can form during the drug manufacturing process.

What You Should Do

This recall affects Lupin brand Irbesartan Tablets USP (75 mg, 150 mg, and 300 mg) and Irbesartan and Hydrochlorothiazide Tablets USP (150/12.5 mg and 300/12.5 mg) sold in 30-count and 90-count bottles.
To identify if your medication is affected, check the bottle label for specific NDC codes, lot numbers, and expiration dates. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Irbesartan Tablets USP, 75 mg

Variants: 75 mg, 30 count bottle, 90 count bottle, Rx only

Lot Numbers:

H000843 (Exp 28/02/2023)

H805727 (Exp 30/11/2021)

H901579 (Exp 31/03/2022)

H000844 (Exp 28/02/2023)

H000964 (Exp 31/03/2023)

H804311 (Exp 31/08/2021)

H805267 (Exp 30/11/2021)

H805268 (Exp 30/11/2021)

H805269 (Exp 30/11/2021)

H805725 (Exp 30/11/2021)

H805726 (Exp 30/11/2021)

H901497 (Exp 31/01/2022)

H901577 (Exp 31/03/2022)

H901578 (Exp 31/03/2022)

H902258 (Exp 31/05/2022)

NDC:

68180-410-06

68180-410-09

Recall #: D-0086-2022. Quantity: 51,144 bottles.

Product: Irbesartan Tablets USP, 150 mg

Variants: 150 mg, 30 count bottle, 90 count bottle, Rx only

Lot Numbers:

H804403 (Exp 31/08/2021)

H805251 (Exp 30/11/2021)

H805640 (Exp 30/11/2021)

H901580 (Exp 30/04/2022)

H804492 (Exp 31/08/2021)

H805252 (Exp 30/11/2021)

H805253 (Exp 30/11/2021)

H805641 (Exp 30/11/2021)

H805642 (Exp 30/11/2021)

H805643 (Exp 30/11/2021)

H901581 (Exp 30/04/2021)

H902139 (Exp 30/04/2022)

H902140 (Exp 30/04/2022)

NDC:

68180-411-06

68180-411-09

Recall #: D-0087-2022. Quantity: 134,016 bottles.

Product: Irbesartan Tablets USP, 300 mg

Variants: 300 mg, 30 count bottle, 90 count bottle, Rx only

Lot Numbers:

H804310 (Exp 31/08/2021)

H900050 (Exp 30/11/2021)

H902262 (Exp 31/05/2022)

H000845 (Exp 28/02/2023)

H000846 (Exp 28/02/2023)

H000965 (Exp 31/03/2023)

H805345 (Exp 30/11/2021)

H805346 (Exp 30/11/2021)

H805347 (Exp 30/11/2021)

H805724 (Exp 30/11/2021)

H900061 (Exp 31/12/2021)

H900062 (Exp 31/12/2021)

H900445 (Exp 31/01/2022)

H901489 (Exp 31/03/2022)

H901490 (Exp 31/03/2022)

H901491 (Exp 31/03/2022)

H902261 (Exp 31/05/2022)

NDC:

68180-412-06

68180-412-09

Recall #: D-0088-2022. Quantity: 119,544 bottles.

Product: Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg

Variants: 150/12.5 mg, 30 count bottle, 90 count bottle, Rx only

Lot Numbers:

H804537 (Exp 30/09/2021)

H805148 (Exp 31/10/2021)

H900063 (Exp 31/10/2021)

H900522 (Exp 31/12/2021)

H901582 (Exp 31/01/2022)

H000963 (Exp 30/04/2022)

H804507 (Exp 30/04/2022)

H804536 (Exp 30/09/2021)

H805070 (Exp 31/10/2021)

H805149 (Exp 31/10/2021)

H900064 (Exp 31/12/2021)

H900523 (Exp 31/01/2022)

H901583 (Exp 30/04/2022)

H902530 (Exp 30/04/2022)

NDC:

68180-413-06

68180-413-09

Recall #: D-0089-2022. Quantity: 63,408 bottles.

Product: Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg

Variants: 300/12.5 mg, 30 count bottle, 90 count bottle, Rx only

Lot Numbers:

H804192 (Exp 31/08/2021)

H805348 (Exp 30/11/2021)

H900065 (Exp 31/12/2021)

H902264 (Exp 31/05/2022)

H804082 (Exp 31/08/2021)

H804121 (Exp 31/08/2021)

H804338 (Exp 31/08/2021)

H804538 (Exp 30/09/2021)

H804539 (Exp 30/09/2021)

H805349 (Exp 30/11/2021)

H805350 (Exp 30/11/2021)

H900066 (Exp 31/12/2021)

H900067 (Exp 31/12/2021)

H902265 (Exp 31/05/2022)

H902275 (Exp 31/05/2022)

H902276 (Exp 31/05/2022)

H902531 (Exp 30/04/2022)

H902532 (Exp 30/04/2022)

NDC:

68180-414-06

68180-414-09

Recall #: D-0090-2022. Quantity: 98,052 bottles.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88856

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: major distributors

Manufactured In: United States

Units Affected: 5 products (51,144 bottles; 134,016 bottles; 119,544 bottles; 63,408 bottles; 98,052 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Lupin brand Irbesartan Tablets USP (75 mg, 150 mg, and 300 mg) and Irbesartan and Hydrochlorothiazide Tablets USP (150/12.5 mg and 300/12.5 mg) sold in 30-count and 90-count bottles.

To identify if your medication is affected, check the bottle label for specific NDC codes, lot numbers, and expiration dates. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Irbesartan Tablets USP, 75 mg

Variants: 75 mg, 30 count bottle, 90 count bottle, Rx only

Lot Numbers:

H000843 (Exp 28/02/2023)

H805727 (Exp 30/11/2021)

H901579 (Exp 31/03/2022)

H000844 (Exp 28/02/2023)

H000964 (Exp 31/03/2023)

H804311 (Exp 31/08/2021)

H805267 (Exp 30/11/2021)

H805268 (Exp 30/11/2021)

H805269 (Exp 30/11/2021)

H805725 (Exp 30/11/2021)

H805726 (Exp 30/11/2021)

H901497 (Exp 31/01/2022)

H901577 (Exp 31/03/2022)

H901578 (Exp 31/03/2022)

H902258 (Exp 31/05/2022)

NDC:

68180-410-06

68180-410-09

Recall #: D-0086-2022. Quantity: 51,144 bottles.

Product: Irbesartan Tablets USP, 150 mg

Variants: 150 mg, 30 count bottle, 90 count bottle, Rx only

Lot Numbers:

H804403 (Exp 31/08/2021)

H805251 (Exp 30/11/2021)

H805640 (Exp 30/11/2021)

H901580 (Exp 30/04/2022)

H804492 (Exp 31/08/2021)

H805252 (Exp 30/11/2021)

H805253 (Exp 30/11/2021)

H805641 (Exp 30/11/2021)

H805642 (Exp 30/11/2021)

H805643 (Exp 30/11/2021)

H901581 (Exp 30/04/2021)

H902139 (Exp 30/04/2022)

H902140 (Exp 30/04/2022)

NDC:

68180-411-06

68180-411-09

Recall #: D-0087-2022. Quantity: 134,016 bottles.

Product: Irbesartan Tablets USP, 300 mg

Variants: 300 mg, 30 count bottle, 90 count bottle, Rx only

Lot Numbers:

H804310 (Exp 31/08/2021)

H900050 (Exp 30/11/2021)

H902262 (Exp 31/05/2022)

H000845 (Exp 28/02/2023)

H000846 (Exp 28/02/2023)

H000965 (Exp 31/03/2023)

H805345 (Exp 30/11/2021)

H805346 (Exp 30/11/2021)

H805347 (Exp 30/11/2021)

H805724 (Exp 30/11/2021)

H900061 (Exp 31/12/2021)

H900062 (Exp 31/12/2021)

H900445 (Exp 31/01/2022)

H901489 (Exp 31/03/2022)

H901490 (Exp 31/03/2022)

H901491 (Exp 31/03/2022)

H902261 (Exp 31/05/2022)

NDC:

68180-412-06

68180-412-09

Recall #: D-0088-2022. Quantity: 119,544 bottles.

Product: Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg

Variants: 150/12.5 mg, 30 count bottle, 90 count bottle, Rx only

Lot Numbers:

H804537 (Exp 30/09/2021)

H805148 (Exp 31/10/2021)

H900063 (Exp 31/10/2021)

H900522 (Exp 31/12/2021)

H901582 (Exp 31/01/2022)

H000963 (Exp 30/04/2022)

H804507 (Exp 30/04/2022)

H804536 (Exp 30/09/2021)

H805070 (Exp 31/10/2021)

H805149 (Exp 31/10/2021)

H900064 (Exp 31/12/2021)

H900523 (Exp 31/01/2022)

H901583 (Exp 30/04/2022)

H902530 (Exp 30/04/2022)

NDC:

68180-413-06

68180-413-09

Recall #: D-0089-2022. Quantity: 63,408 bottles.

Product: Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg

Variants: 300/12.5 mg, 30 count bottle, 90 count bottle, Rx only

Lot Numbers:

H804192 (Exp 31/08/2021)

H805348 (Exp 30/11/2021)

H900065 (Exp 31/12/2021)

H902264 (Exp 31/05/2022)

H804082 (Exp 31/08/2021)

H804121 (Exp 31/08/2021)

H804338 (Exp 31/08/2021)

H804538 (Exp 30/09/2021)

H804539 (Exp 30/09/2021)

H805349 (Exp 30/11/2021)

H805350 (Exp 30/11/2021)

H900066 (Exp 31/12/2021)

H900067 (Exp 31/12/2021)

H902265 (Exp 31/05/2022)

H902275 (Exp 31/05/2022)

H902276 (Exp 31/05/2022)

H902531 (Exp 30/04/2022)

H902532 (Exp 30/04/2022)

NDC:

68180-414-06

68180-414-09

Recall #: D-0090-2022. Quantity: 98,052 bottles.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88856

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: major distributors

Manufactured In: United States

Units Affected: 5 products (51,144 bottles; 134,016 bottles; 119,544 bottles; 63,408 bottles; 98,052 bottles)

Distributed To: Nationwide