Recalls / Class II
Class IID-0086-2024
Product
Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.
- Brand name
- Montelukast Sodium
- Generic name
- Montelukast Sodium
- Active ingredient
- Montelukast Sodium
- Route
- Oral
- NDCs
- 55111-593, 55111-725, 55111-594
- FDA application
- ANDA201581
- Affected lot / code info
- Lot # C2305569, Exp. date 03/31/2026
Why it was recalled
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr.Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 1,656 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2023-10-13
- FDA classified
- 2023-11-03
- Posted by FDA
- 2023-11-15
- Terminated
- 2024-09-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0086-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.