Recalls / Class III
Class IIID-0047-2025
Product
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
- Brand name
- Ibu
- Generic name
- Ibuprofen
- Active ingredient
- Ibuprofen
- Route
- Oral
- NDCs
- 55111-682, 55111-683, 55111-684
- FDA application
- ANDA075682
- Affected lot / code info
- Lot #: C5406201, Exp 03/31/2028
Why it was recalled
Failed Tablet/Capsule Specifications
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 3416 botttles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2024-10-29
- FDA classified
- 2024-11-15
- Posted by FDA
- 2024-11-27
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0047-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.