Ramipril Capsules USP 5 mg recall
FDA recall D-0053-2025 · initiated Oct 23, 2024
Lupin Pharmaceuticals Inc. recalled Ramipril Capsules USP 5 mg in Oct 2024 — an FDA Class II recall (D-0053-2025) because CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 146,322 bottles
Details
- Product
- 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
- Recalling company
- Lupin Limited
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
- Initiated
- Oct 23, 2024
- FDA report date
- Nov 27, 2024
Frequently asked
- Was Ramipril Capsules USP 5 mg recalled?
- Lupin Pharmaceuticals Inc. recalled Ramipril Capsules USP 5 mg in Oct 2024 — an FDA Class II recall (D-0053-2025) because CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Ramipril Capsules USP 5 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0053-2025 was: CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
- Is a recalled Ramipril Capsules USP 5 mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Ramipril Capsules USP 5 mg are affected?
- Distributed: Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.. The recall covers these lots — 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. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0053-2025.