FDA Drug recall D-0047-2025
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India,…
- FDA Drug
- Class III
- ongoing
- Published 2024-11-27
On 2024-11-27 the FDA classified a Class III recall of IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India,… by Dr Reddy S Laboratories, citing failed Tablet/Capsule Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0047-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-10-29 |
| Published | 2024-11-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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
Reason
Failed Tablet/Capsule Specifications
Identifiers
| ndc | 55111-682-09 |
|---|---|
| ndc | 55111-682-01 |
| ndc | 55111-682-05 |
| ndc | 55111-683-30 |
| ndc | 55111-683-50 |
| ndc | 55111-683-09 |
| ndc | 55111-683-01 |
| ndc | 55111-683-05 |
| ndc | 55111-684-30 |
| ndc | 55111-684-50 |
| ndc | 55111-684-60 |
| ndc | 55111-684-09 |
| ndc | 55111-684-01 |
| ndc | 55111-684-05 |
| code_info | Lot #: C5406201, Exp 03/31/2028 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0047-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.