The Recall Desk
HighFDA (Drugs)·D-0812-2021·Announced 2021-09-29

Metoprolol Tartrate Tablets Recalled for Metal Wire Contamination

Aurobindo Pharma USA Inc. is recalling Metoprolol Tartrate 100 mg tablets due to the presence of metal wire found in at least one tablet. The FDA classified this as a Class II recall affecting 2,820 bottles distributed nationwide.

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: This is an FDA Class II recall involving a risk-of-harm hazard (metal wire contamination in a critical cardiac medication). Although no illnesses or injuries have been reported, the presence of a foreign object in a prescription drug that cannot be visually detected by patients creates significant potential for patient injury. Class II recalls require a score of at least 3, and the nature of this hazard (physical contamination in a heart medication) justifies a High severity rating.

Plain-English summary

Aurobindo Pharma USA Inc. is recalling Metoprolol Tartrate Tablets USP 100 mg (1,000-count bottles) distributed nationwide in the United States. The recall was initiated after product complaints identified the presence of metal wire in one tablet.

The affected product is Lot MJ1019025-A with an expiration date of 04/2022, distributed under NDC 65862-064-99. A total of 2,820 bottles have been distributed.

Metoprolol tartrate is a prescription medication used to treat heart conditions. Consumers who have this product should stop taking it and contact their pharmacist or healthcare provider. Patients should not discontinue their heart medication without medical guidance; they should consult their doctor about obtaining unaffected product or alternative treatment options.

Healthcare providers and pharmacists should check their inventory for the affected lot and quarantine any remaining stock. Consumers with questions can contact Aurobindo Pharma USA Inc. at 279 Princeton-Highstown Road East Windsor, NJ 08520.

The recalled product

Product
METOPROLOL TARTRATE (METOPROLOL TARTRATE)
Brand
METOPROLOL TARTRATE
Manufacturer
Aurobindo Pharma USA Inc.
Hazard
  • metal-contamination
  • foreign-object

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)

  • Lot: MJ1019025-A
  • Exp. date 04/2022

Distribution

Distributed nationwide across the United States.