Why it was recalled
Failed Tablet/Capsule Specifications
Product description
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
Lot numbers, UPCs & expiration codes
Lot #: C5406201, Exp 03/31/2028
Where it was sold
USA 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-0047-2025
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Oct 29, 2024
- FDA report date
- Nov 27, 2024
- Quantity
- 3416 botttles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0047-2025, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95620
- Address
- 107 College Rd E
- Code information
- Lot #: C5406201, Exp 03/31/2028
- Postal code
- 08540-6623
- Report date
- Nov 27, 2024
- Product type
- Drugs
- Recall number
- D-0047-2025
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 3416 botttles
- Reason for recall
- Failed Tablet/Capsule Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Oct 29, 2024
- Center classification date
- Nov 15, 2024