Capsules Pulled for CGMP Deviation
Lupin Pharmaceuticals Inc. is recalling more than a half million bottles of ramipril capsules because of a deviation from Current Good Manufacturing Practice (CGMP) regulations. According to the November 27, 2024, US Food and Drug Administration (FDA) Enforcement Report, the active pharmaceutical ingredient in the tablets was sourced from an unapproved vendor.
The recall affects the following ramipril products, which were manufactured for Lupin Pharmaceuticals Inc., Baltimore, Maryland, by Lupin Limited, Goa, India:
- ramipril capsules, 2.5 mg, in 90-count bottles (NDC 68180-589-09), from lots G326781 (Exp. 9/30/25) and GA04468 (Exp. 5/31/25);
- ramipril capsules, 2.5 mg, in 100-count bottles (NDC 68180-589-01), from lots G326763 (Exp. 9/30/25), GA03041 (Exp. 3/31/26), GA03725 (Exp. 4/30/26), and GA04402 (Exp. 5/31/26);
- ramipril capsules, 2.5 mg, in 500-count bottles (NDC 68180-589-02), from lots G326782 (Exp. 9/30/25) and GA04462 (Exp. 5/31/26);
- ramipril capsules, 5 mg, in 90-count bottles (NDC 68180-590-09), from lots G326928 (Exp. 9/30/25) and GA00964 (Exp. 12/31/25);
- ramipril capsules, 5 mg, in 100-count bottles (NDC 68180-590-01), from lots G326897 (Exp. 9/30/25), G326929 (Exp. 9/30/25), GA00854 (Exp. 12/31/25), GA00933 (Exp. 12/31/25), and GA00954 (Exp. 12/31/25);
- ramipril capsules, 5 mg, in 500-count bottles (NDC 68180-590-02), from lot GA00955 (Exp. 12/31/25);
- ramipril capsules, 10 mg, in 90-count bottles (NDC 68180-591-09), from lots G327086 (Exp. 9/30/25) and GA01065 (Exp. 12/31/25);
- ramipril capsules, 10 mg, in 100-count bottles (NDC 68180-591-01), from lots G325033 (Exp. 7/31/25), G324987 (Exp. 7/31/25), G325110 (Exp. 12/31/25), GA00956 (Exp. 12/31/25), GA01066 (Exp. 12/31/25), GA01126 (Exp. 12/31/25), GA03299 (Exp. 3/31/26), GA03288 (Exp. 3/31/26), and GA03287 (Exp. 3/31/26); and
- ramipril capsules, 10 mg, in 500-count bottles (NDC 68180-591-02), from lots GA05919 (Exp. 7/31/26) and G327131 (Exp. 9/30/25).
The affected ramipril was distributed to 30 wholesalers/distributors that may have further distributed the product throughout the United States.
Lupin Pharmaceuticals voluntarily initiated the recall on October 23, 2024. The FDA designated the recall Class II on November 19, 2024. Per the classification, the use of the product could cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Ramipril is a prescription angiotensin-converting enzyme (ACE) inhibitor used to treat patients with high blood pressure and heart failure and to improve survival after a heart attack.
