Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Div
Summary
The FDA issued a Class II for Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic by Alembic Pharmaceuticals Limited. Reason: Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule.
Details
Source
Drug Recall
External ID
D-0459-2025
Action Date
2025-06-18
Status
Ongoing
Category
drug
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
Lot/Code Info: Batch 2405014780, Exp. Date: Sep. 30, 2027
Quantity Affected: 2,946 500-count bottles
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
Distributed Nationwide and in PR
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-09
Company
Panchmahal
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 54 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Alembic Pharmaceuticals Limited has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Alembic Pharmaceuticals Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Alembic Pharmaceuticals Limited have FDA actions?
Alembic Pharmaceuticals Limited has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0459-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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