D-0459-2025 Class II Ongoing
FDA drug recall D-0459-2025 was initiated by Alembic Pharmaceuticals Limited on May 9, 2025 and is designated Class II. Reason for recall: Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule The recall status is ongoing. Affected quantity: 2,946 500-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 18, 2025
- Initiation Date
- May 9, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,946 500-count bottles
Product Description
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 for Recall
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Distribution Pattern
Distributed Nationwide and in PR
Code Information
Batch 2405014780, Exp. Date: Sep. 30, 2027
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0459-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026