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Drug FDA Class II Terminated cGMP deviation

Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

Lupin Pharmaceuticals Inc. Published Nov 27, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Lupin Pharmaceuticals Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

Affected products (1)

Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

RAMIPRIL · 146,322 bottles

NDC: 68180-588, 68180-589, 68180-590, 68180-591, 68180-589-09, 68180-589-10, 68180-589-01, 68180-589-02, 68180-590-09, 68180-590-10, 68180-590-01, 68180-590-02, 68180-591-09, 68180-591-10, 68180-591-02, 68180-591-01, 68180-588-01, 68180-588-02, 68180-588-09
Lot codes: G326928, G326897, GA00955
Code info: a) NDC 68180-590-09; Lots G326928, exp. date 30-Sep-25, GA00964, exp. date 31-Dec-25, b) NDC 68180-590-01, Lots G326897, G326929, exp. date 30-Sep-25, GA00854, GA00933, GA00954, exp. date 31-Dec-25, c) NDC 68180-590-02, Lot GA00955, exp. date 31-Dec-25

Affected areas

Nationwide

Timeline

  1. Initiated
    Oct 23, 2024
  2. Published
    Nov 27, 2024
  3. Terminated
    Jan 5, 2026
Recall number
D-0053-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.