Celecoxib Capsule
FDA Recall NDC 62332-142
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Celecoxib (NDC 62332-142). A significant event, classified as Class II, was initiated on May 09, 2025 by Alembic Pharmaceuticals Inc.. The reported reason for this action was: "Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
May 2025 Class II Recall: Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Recall Number
Class II Ongoing
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
May 09, 2025
Jun 18, 2025
2,946 500-count bottles
Recall Profile & Regulatory Data
Event ID
96840
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Alembic Pharmaceuticals Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide and in PR
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
Batch or Lot Expiration Information
Batch# Batch 2405014780, Exp. Date: Sep. 30, 2027
Affected Packages Involved in this Recall
62332-140-30Product
62332-140-60Product
62332-140-91Product
62332-140-08Product
62332-141-30Product
62332-141-31Product
62332-141-91Product
62332-141-08Product
62332-141-60Product
62332-141-71Product
62332-142-30Product
62332-142-31Product
62332-142-91Product
62332-142-71Product
62332-142-08Product
62332-142-60Product
62332-143-30Product
62332-143-60Product
62332-143-71Product
62332-143-10Product
2405014780Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
