FDA Drugs recall ·
Celecoxib Capsules, 200 mg, 500-count bottle, Rx only… recall
- Recall number
- D-0459-2025
- Date
- (initiated May 9, 2025)
- Company / brand
- Alembic Pharmaceuticals Limited
Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol, Panchmahal, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2,946 500-count bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Batch 2405014780, Exp. Date: Sep. 30, 2027
Distribution
Distributed Nationwide and in PR
States: Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0459-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.