FDA Drug recall D-0459-2025
Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389…
- FDA Drug
- Class II
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389… by Alembic Pharmaceuticals, citing presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0459-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-09 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Alembic Pharmaceuticals |
| Distribution | US |
Product
Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71
Reason
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Identifiers
| ndc | 62332-140-30 |
|---|---|
| ndc | 62332-140-60 |
| ndc | 62332-140-91 |
| ndc | 62332-140-08 |
| ndc | 62332-141-30 |
| ndc | 62332-141-31 |
| ndc | 62332-141-91 |
| ndc | 62332-141-08 |
| ndc | 62332-141-60 |
| ndc | 62332-141-71 |
| ndc | 62332-142-30 |
| ndc | 62332-142-31 |
| ndc | 62332-142-91 |
| ndc | 62332-142-71 |
| ndc | 62332-142-08 |
| ndc | 62332-142-60 |
| ndc | 62332-143-30 |
| ndc | 62332-143-60 |
| ndc | 62332-143-71 |
| ndc | 62332-143-10 |
| ndc | 2405014780 |
| code_info | Batch 2405014780, Exp. Date: Sep. 30, 2027 |
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-0459-2025%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.