Metoprolol Tartrate Tablets USP recall
FDA recall D-0517-2024 · initiated May 6, 2024
Rubicon Research Private Limited recalled Metoprolol Tartrate Tablets USP in May 2024 — an FDA Class II recall (D-0517-2024) because Presence of Foreign Substance: metal in tablet.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Foreign Substance: metal in tablet
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
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: 11,664 Bottles
Details
- Product
- Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00
- Recalling company
- Rubicon Research Private Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide
- Initiated
- May 6, 2024
- FDA report date
- Jun 5, 2024
Frequently asked
- Was Metoprolol Tartrate Tablets USP recalled?
- Rubicon Research Private Limited recalled Metoprolol Tartrate Tablets USP in May 2024 — an FDA Class II recall (D-0517-2024) because Presence of Foreign Substance: metal in tablet. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Metoprolol Tartrate Tablets USP recalled?
- Per the FDA enforcement record, the reason for recall D-0517-2024 was: Presence of Foreign Substance: metal in tablet
- Is a recalled Metoprolol Tartrate Tablets USP 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 USP are affected?
- Distributed: Nationwide. The recall covers these lots — Lot 231037H1, exp 6/2027. 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-0517-2024.