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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # C2305569, Exp. date 03/31/2026
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0086-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 13, 2023
- FDA report date
- Nov 15, 2023
- Quantity
- 1,656 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0086-2024, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 93225
- Address
- 107 College Rd E
- Code information
- Lot # C2305569, Exp. date 03/31/2026
- Postal code
- 08540-6623
- Report date
- Nov 15, 2023
- Product type
- Drugs
- Recall number
- D-0086-2024
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 1,656 bottles
- Termination date
- Sep 9, 2024
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 13, 2023
- Initial firm notification
- Letter
- Center classification date
- Nov 3, 2023