CLASS II Drug recall · Reported 19 Jan 2022 · FDA Enforcement Report
Metoprolol Tartrate Tablets, USP 25 mg recalled
Rubicon Research Private is recalling Metoprolol Tartrate Tablets, USP 25 mg, distributed nationwide in the US. The recall was initiated on 31 Dec 2021 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-0362-2022
- FDA event ID
- 89311
- Recalling firm
- Rubicon Research Private, Ambernath, N/A
- Brand
- Metoprolol Tartrate
- Manufacturer
- TruPharma LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Dec 2021
- FDA classified
- 7 Jan 2022
- Reported
- 19 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Blood Pressure Medication
Timeline
| 31 Dec 2021 | Recall initiated by company | |
| 7 Jan 2022 | Classified by FDA | +7 days |
| 19 Jan 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Complaint received of foreign matter (metal) embedded 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 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-00
Where it was distributed
Product was distributed to one distributor who may have distributed the product further nationwide.
Questions about this recall
Why was it recalled?
Complaint received of foreign matter (metal) embedded in tablet.
Which lots are affected?
Batch # 210211H1, Exp. date FEB 2024
Where was it sold?
Product was distributed to one distributor who may have distributed the product further 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 | Metoprolol Tartrate Tablets USP, 25mg recalledMetoprolol Tartrate | Rubicon Research Private | Foreign Material | Nationwide |
| Drug | CLASS II | traMADol Hydrochloride Tablets, USP 50 mg recalledTramadol Hydrochloride | Rubicon Research Private | Other | 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 |