Drug Recall: Montelukast Sodium Tablets Contaminated with Foreign Metoprolol Tablet
Dr. Reddy's Laboratories is recalling 1,656 bottles of Montelukast Sodium 10 mg tablets due to contamination with a foreign metoprolol tablet found in at least one bottle. Affected lots were distributed nationwide.
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 3/5 (High).
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: A foreign prescription medication was found in the recalled product, creating a direct risk-of-harm to patients who might unknowingly ingest an unintended drug. No illnesses or injuries have been reported, placing this at the High severity level per the rubric.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 1,656 bottles of Montelukast Sodium Tablets, USP 10 mg with Lot # C2305569 and expiration date 03/31/2026. These bottles were distributed nationwide.
A foreign tablet identified as metoprolol 25 mg was discovered in a bottle of the recalled product. Montelukast Sodium is a prescription medication for asthma and allergies. Metoprolol is a separate prescription medication for blood pressure control and should not be present in asthma medication containers.
The recalled product
- Product
- MONTELUKAST SODIUM (MONTELUKAST SODIUM)
- Brand
- MONTELUKAST SODIUM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Affected units
- 1,656
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 # C2305569
- Exp. date 03/31/2026
Distribution
Distributed nationwide across the United States.
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