Medications & Supplements/Prescription Drugs

Lupin Pharmaceuticals Ramipril Capsules Recalled for Unapproved Ingredient Source

Agency Publication Date: November 19, 2024

Summary

Lupin Pharmaceuticals Inc. is voluntarily recalling 616,506 bottles of Ramipril capsules (generic Ramipril) in 2.5 mg, 5 mg, and 10 mg strengths. The recall was initiated because the active pharmaceutical ingredient was sourced from an unapproved vendor, which is a violation of current Good Manufacturing Practice (CGMP) standards. This means the manufacturer cannot guarantee that the product meets necessary purity, quality, and safety specifications.

Risk

Medications sourced from unapproved vendors may not meet safety standards, potentially affecting the drug's effectiveness or purity. No adverse events or injuries have been reported to date in connection with this recall.

What You Should Do

This recall affects Ramipril capsules (USP 2.5 mg, 5 mg, and 10 mg) sold under the Lupin Pharmaceuticals brand in 90-count, 100-count, and 500-count bottles. Affected NDC codes include 68180-589-09, 68180-589-01, 68180-589-02, 68180-590-09, 68180-590-01, 68180-590-02, 68180-591-09, 68180-591-01, and 68180-591-02.
Check the lot number and expiration date printed on your medication bottle to see if your product is included in this recall. 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 information.

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: Ramipril Capsules USP 2.5 mg

Variants: 2.5 mg, Capsule

Lot Numbers:

G326781 (Exp 30-Sep-25)

GA04468 (Exp 31-May-25)

G326763 (Exp 30-Sep-25)

GA03041 (Exp 31-Mar-26)

GA03725 (Exp 30-Apr-26)

GA04402 (Exp 31-May-26)

G326782 (Exp 30-Sep-25)

GA04462 (Exp 31-May-26)

NDC:

68180-589-09

68180-589-01

68180-589-02

Available in 90, 100, and 500 count bottles; Rx only.

Product: Ramipril Capsules USP 5 mg

Variants: 5 mg, Capsule

Lot Numbers:

G326928 (Exp 30-Sep-25)

GA00964 (Exp 31-Dec-25)

G326897 (Exp 30-Sep-25)

G326929 (Exp 30-Sep-25)

GA00854 (Exp 31-Dec-25)

GA00933 (Exp 31-Dec-25)

GA00954 (Exp 31-Dec-25)

GA00955 (Exp 31-Dec-25)

NDC:

68180-590-09

68180-590-01

68180-590-02

Available in 90, 100, and 500 count bottles; Rx only.

Product: Ramipril Capsules USP 10 mg

Variants: 10 mg, Capsule

Lot Numbers:

G327086 (Exp 30-Sep-25)

GA01065 (Exp 31-Dec-25)

G325033 (Exp 31-Jul-25)

G324987 (Exp 31-Jul-25)

G325110 (Exp 31-Dec-25)

GA00956 (Exp 31-Dec-25)

GA01066 (Exp 31-Dec-25)

GA01126 (Exp 31-Dec-25)

GA03299 (Exp 31-Mar-26)

GA03288 (Exp 31-Mar-26)

GA03287 (Exp 31-Mar-26)

GA05919 (Exp 31-Jul-26)

G327131 (Exp 30-Sep-25)

NDC:

68180-591-09

68180-591-01

68180-591-02

Available in 90, 100, and 500 count bottles; Rx only.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95610

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: Wholesalers; Distributors; Pharmacies

Manufactured In: United States, India

Units Affected: 3 products (112,770 bottles; 146,322 bottles; 357,414 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 Ramipril capsules (USP 2.5 mg, 5 mg, and 10 mg) sold under the Lupin Pharmaceuticals brand in 90-count, 100-count, and 500-count bottles. Affected NDC codes include 68180-589-09, 68180-589-01, 68180-589-02, 68180-590-09, 68180-590-01, 68180-590-02, 68180-591-09, 68180-591-01, and 68180-591-02.

Check the lot number and expiration date printed on your medication bottle to see if your product is included in this recall. 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 information.

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: Ramipril Capsules USP 2.5 mg

Variants: 2.5 mg, Capsule

Lot Numbers:

G326781 (Exp 30-Sep-25)

GA04468 (Exp 31-May-25)

G326763 (Exp 30-Sep-25)

GA03041 (Exp 31-Mar-26)

GA03725 (Exp 30-Apr-26)

GA04402 (Exp 31-May-26)

G326782 (Exp 30-Sep-25)

GA04462 (Exp 31-May-26)

NDC:

68180-589-09

68180-589-01

68180-589-02

Available in 90, 100, and 500 count bottles; Rx only.

Product: Ramipril Capsules USP 5 mg

Variants: 5 mg, Capsule

Lot Numbers:

G326928 (Exp 30-Sep-25)

GA00964 (Exp 31-Dec-25)

G326897 (Exp 30-Sep-25)

G326929 (Exp 30-Sep-25)

GA00854 (Exp 31-Dec-25)

GA00933 (Exp 31-Dec-25)

GA00954 (Exp 31-Dec-25)

GA00955 (Exp 31-Dec-25)

NDC:

68180-590-09

68180-590-01

68180-590-02

Available in 90, 100, and 500 count bottles; Rx only.

Product: Ramipril Capsules USP 10 mg

Variants: 10 mg, Capsule

Lot Numbers:

G327086 (Exp 30-Sep-25)

GA01065 (Exp 31-Dec-25)

G325033 (Exp 31-Jul-25)

G324987 (Exp 31-Jul-25)

G325110 (Exp 31-Dec-25)

GA00956 (Exp 31-Dec-25)

GA01066 (Exp 31-Dec-25)

GA01126 (Exp 31-Dec-25)

GA03299 (Exp 31-Mar-26)

GA03288 (Exp 31-Mar-26)

GA03287 (Exp 31-Mar-26)

GA05919 (Exp 31-Jul-26)

G327131 (Exp 30-Sep-25)

NDC:

68180-591-09

68180-591-01

68180-591-02

Available in 90, 100, and 500 count bottles; Rx only.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95610

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: Wholesalers; Distributors; Pharmacies

Manufactured In: United States, India

Units Affected: 3 products (112,770 bottles; 146,322 bottles; 357,414 bottles)

Distributed To: Nationwide