Metoprolol Tartrate Tablets Recalled for Foreign Metal in Tablets
Rubicon Research Private Limited is recalling Metoprolol Tartrate 25 mg tablets (batch #210211H1, expiration February 2024) due to a complaint of metal embedded in a tablet.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a physical contaminant (metal) that poses an immediate risk of harm to patients who ingest the affected tablets. Although no illnesses or injuries have been reported, the presence of foreign metal in a consumable drug product creates a direct hazard that warrants a High severity rating under the rubric criteria for risk-of-harm products.
Plain-English summary
Rubicon Research Private Limited is recalling Metoprolol Tartrate Tablets, USP 25 mg, supplied in 1000-count bottles (NDC 52817-360-00 and other NDCs) distributed by TruPharma, LLC. The recall was initiated after a complaint was received reporting foreign metal matter embedded in a tablet.
The affected batch is #210211H1 with an expiration date of February 2024. A total of 3,684 bottles of 1000-count product were distributed through one distributor, which may have distributed the product further nationwide.
Consumers who have this product should stop using it immediately and contact their pharmacist or healthcare provider. Patients taking this medication should not stop their regimen without medical guidance but should obtain a replacement from their pharmacy or physician.
The recalled product
- Product
- METOPROLOL TARTRATE (METOPROLOL TARTRATE)
- Brand
- METOPROLOL TARTRATE
- Manufacturer
- Rubicon Research Private Limited
- Category
- Drug — Prescription Oral Tablet
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch # 210211H1
- Exp. date FEB 2024
UPCs (10)
- 0352817361103
- 0352817361004
- 0352817360106
- 0352817362100
- 0352817358509
- 0352817359506
- 0352817362001
- 0352817360007
- 0352817358103
- 0352817359100
Distribution
Distributed nationwide across the United States.
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