The Recall Desk
HighFDA (Drugs)·D-0581-2025·Announced 2025-08-20

[pending] METOPROLOL TARTRATE (METOPROLOL TARTRATE)

Pending LLM rewrite. Source: FDA_DRUG D-0581-2025.

What this means for you

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: Pending LLM scoring against the rubric.

Plain-English summary

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

The recalled product

Product
METOPROLOL TARTRATE (METOPROLOL TARTRATE)
Brand
METOPROLOL TARTRATE
Manufacturer
Westminster Pharmaceuticals LLC
Category
Drug — Drugs

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 (20)

  • Batch # R55230021
  • R55230031
  • R55230041
  • Exp Date: 9/30/25
  • Batch # R55230051
  • R55230061
  • R55230071
  • R55230081
  • R55230091
  • R55230101
  • R55230111
  • R55230121
  • R55230131
  • R55230141
  • Exp Date: 10/31/2025
  • Batch # R55230151
  • Exp Date: 11/30/25
  • Batch # R55240011
  • Exp Date: 12/31/25
  • Batch # R55240021

UPCs (3)

  • 0369367355018
  • 0369367354103
  • 0369367354011

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · METOPROLOL TARTRATE

Same category