CLASS II ONGOING Drug recall · Reported 5 Jun 2024 · FDA Enforcement Report
Metoprolol Tartrate Tablets USP, 25mg recalled
Rubicon Research Private is recalling Metoprolol Tartrate Tablets USP, 25mg, distributed nationwide in the US. The recall was initiated on 6 May 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0517-2024
- FDA event ID
- 94542
- Recalling firm
- Rubicon Research Private, Ambarnath
- Brand
- Metoprolol Tartrate
- Manufacturer
- TruPharma LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 May 2024
- FDA classified
- 29 May 2024
- Reported
- 5 Jun 2024
- Type
- Voluntary: Firm initiated
- Reason category
- Foreign Material
- Drug class
- Blood Pressure Medication
Timeline
| 6 May 2024 | Recall initiated by company | |
| 29 May 2024 | Classified by FDA | +23 days |
| 5 Jun 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: metal in tablet
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: metal in tablet
Which lots are affected?
Lot 231037H1, exp 6/2027
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Rubicon Research Private
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | AcetaZOLAMIDE Tablets, USP, 125 mg bottled recalledAcetazolamide | Rubicon Research Private | Other | Nationwide |
| Drug | CLASS II | traMADol Hydrochloride Tablets, USP 50 mg recalledTramadol Hydrochloride | Rubicon Research Private | Other | Nationwide |
| Drug | CLASS II | Metoprolol Tartrate Tablets, USP 25 mg recalledMetoprolol Tartrate | Rubicon Research Private | Foreign Material | Nationwide |
Other Metoprolol recalls
All 40| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* recalledMetoprolol Succinate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, 200 mg recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, 25 mg bottles recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, 50 mg bottles recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |