Medications & Supplements/Prescription Drugs

Lupin Quinapril Hypertension Tablets Recalled for Excessive Impurity Levels

Agency Publication Date: December 23, 2022

Summary

Lupin Pharmaceuticals Inc. is recalling 54,348 bottles of Quinapril Tablets USP (20 mg and 40 mg strengths), a prescription medication used to treat hypertension (high blood pressure). The recall was issued after tests identified a nitrosamine impurity, N-Nitroso-quinapril, at levels that exceed the acceptable daily intake limit set by the FDA. Although no injuries or illnesses have been reported, Lupin is voluntarily removing these specific lots from the market as a precaution.

Risk

N-Nitroso-quinapril is a nitrosamine impurity that may increase the risk of cancer if humans are exposed to it above acceptable levels over a long period of time. No incidents or injuries have been reported to date for this recall.

What You Should Do

This recall affects Lupin brand Quinapril Tablets USP in 20 mg and 40 mg strengths, packaged in 90-count bottles.
Check your prescription bottle for NDC numbers 68180-558-09 (20 mg) or 68180-554-09 (40 mg).
Verify if your medication belongs to one of the following affected lot numbers: G102929 (20 mg), or G100533, G100534, and G203071 (40 mg).
If you have health concerns, contact your healthcare provider or pharmacist immediately before stopping your medication.
Return any unused product to the place of purchase for a refund, throw it away, or contact Lupin Pharmaceuticals Inc. directly 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: Quinapril Tablets USP, 20 mg (90 pack)

Variants: 20 mg, Tablet

UPC Codes:

368180558095

Lot Numbers:

G102929 (Exp 04/2023)

NDC:

68180-558-09

Manufactured for Lupin Pharmaceuticals, Inc. by Lupin Limited, Goa, India.

Product: Quinapril Tablets USP, 40 mg (90 pack)

Variants: 40 mg, Tablet

UPC Codes:

368180554097

Lot Numbers:

G100533 (Exp 12/2022)

G100534 (Exp 12/2022)

G203071 (Exp 03/2024)

NDC:

68180-554-09

Manufactured for Lupin Pharmaceuticals, Inc. by Lupin Limited, Goa, India.

Product Images

Label, Lupin Quinapril 20 mg tablets

Label, Lupin Quinapril 40 mg tablets

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91279

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: major distribution chains

Manufactured In: India, United States

Units Affected: 2 products (23,736; 30,612 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 · FDA Press Release · 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 Quinapril Tablets USP in 20 mg and 40 mg strengths, packaged in 90-count bottles.

Check your prescription bottle for NDC numbers 68180-558-09 (20 mg) or 68180-554-09 (40 mg).

Verify if your medication belongs to one of the following affected lot numbers: G102929 (20 mg), or G100533, G100534, and G203071 (40 mg).

If you have health concerns, contact your healthcare provider or pharmacist immediately before stopping your medication.

Return any unused product to the place of purchase for a refund, throw it away, or contact Lupin Pharmaceuticals Inc. directly 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: Quinapril Tablets USP, 20 mg (90 pack)

Variants: 20 mg, Tablet

UPC Codes:

368180558095

Lot Numbers:

G102929 (Exp 04/2023)

NDC:

68180-558-09

Manufactured for Lupin Pharmaceuticals, Inc. by Lupin Limited, Goa, India.

Product: Quinapril Tablets USP, 40 mg (90 pack)

Variants: 40 mg, Tablet

UPC Codes:

368180554097

Lot Numbers:

G100533 (Exp 12/2022)

G100534 (Exp 12/2022)

G203071 (Exp 03/2024)

NDC:

68180-554-09

Manufactured for Lupin Pharmaceuticals, Inc. by Lupin Limited, Goa, India.