Metoprolol Tartrate Tablets recall
FDA recall D-0582-2025 · initiated Aug 6, 2025
Westminster Pharmaceuticals LLC recalled Metoprolol Tartrate Tablets in Aug 2025 — an FDA Class II recall (D-0582-2025) because CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
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: 4,456 1000-count bottles
Details
- Product
- Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10
- Recalling company
- Westminster Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA.
- Initiated
- Aug 6, 2025
- FDA report date
- Aug 20, 2025
Frequently asked
- Was Metoprolol Tartrate Tablets recalled?
- Westminster Pharmaceuticals LLC recalled Metoprolol Tartrate Tablets in Aug 2025 — an FDA Class II recall (D-0582-2025) because CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Metoprolol Tartrate Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0582-2025 was: CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
- Is a recalled Metoprolol Tartrate Tablets 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 Metoprolol Tartrate Tablets are affected?
- Distributed: Nationwide in the USA.. The recall covers these lots — Batch # R56240011, Exp Date: 2/28/26; Batch # R56240021, R56240031, Exp Date: 3/31/26; Batch # R56240041, R56240051, R56240061, Exp Date: 4/30/26; Batch # R56240071, Exp Date: 7/31/26. 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-0582-2025.