The Recall Desk
HighFDA (Drugs)·D-0191-2024·Announced 2024-01-03

Metoprolol Succinate Extended-Release Tablets Recalled for Storage Temperature Deviations

Cardinal Healthcare is recalling Metoprolol Succinate Extended-Release Tablets (50 mg) nationwide. Batch 2447J211 was exposed to temperatures outside labeled storage conditions, which could compromise medication effectiveness.

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: The FDA classified this as a Class II recall due to CGMP deviations from improper storage temperatures. Although no illnesses or injuries have been reported, temperature exposure of a cardiac medication creates a theoretical risk of reduced effectiveness. The score reflects this risk without confirmed adverse events.

Plain-English summary

Cardinal Healthcare is recalling Metoprolol Succinate Extended-Release Tablets, 50 mg (NDC 45963-676-96), distributed nationwide. The recalled batch is 2447J211.

The recall was initiated due to a Good Manufacturing Practice (CGMP) deviation. Products in the affected batch were exposed to temperatures outside the labeled storage conditions. This exposure may have compromised product quality and effectiveness.

Patients currently taking this medication should contact their healthcare provider or pharmacist regarding their specific situation and medication supply.

The recalled product

Product
METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
Brand
METOPROLOL SUCCINATE
Manufacturer
CARDINAL HEALTHCARE
Category
Drug
Hazard
  • improper-storage
  • potency-degradation

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 (1)

  • Batch 2447J211

Distribution

Distributed nationwide across the United States.