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.
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 2/5 (Moderate).
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
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
- 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
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