The Recall Desk
ModerateFDA (Drugs)·D-1080-2014·Announced 2014-02-12

Dr. Reddy's Recalls Metoprolol Succinate Tablets for Dissolution Failure

Dr. Reddy's is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed dissolution specifications and a 12-month stability interval.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling 8,592 bottles of Metoprolol Succinate Extended-Release Tablets USP, 50 mg. The affected products are identified by Lot # C207420 and C207416 and are distributed in Louisiana, Michigan, Missouri, Mississippi, and Ohio.

The recall was initiated because the tablets failed to meet dissolution specifications and a 12-month stability interval. These failures indicate that the medication may not release the active ingredient as intended or may not remain stable over time.

Consumers who have these specific lots of medication should stop using them and contact their healthcare provider or pharmacist for a replacement. The recalled product is a prescription medication intended for oral use.

The recalled product

Product
METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
Brand
METOPROLOL SUCCINATE
Affected units
8,592

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)

  • Lot # C207420 and C207416

UPCs (2)

  • 0355111466017
  • 0355111467014

Distribution

Distributed in 5 states: