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Drug FDA Class II Ongoing Foreign material

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

Alembic Pharmaceuticals Limited Published Jun 18, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Alembic Pharmaceuticals Limited or your place of purchase with questions, and see the source record below for full details.
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

Hazards

Tadalafil 5mg Tablet · primary

Affected products (1)

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

CELECOXIB · 2,946 500-count bottles

NDC: 62332-140, 62332-141, 62332-142, 62332-143, 62332-140-30, 62332-140-60, 62332-140-91, 62332-140-08, 62332-141-30, 62332-141-31, 62332-141-91, 62332-141-08, 62332-141-60, 62332-141-71, 62332-142-30, 62332-142-31, 62332-142-91, 62332-142-71, 62332-142-08, 62332-142-60, 62332-143-30, 62332-143-60, 62332-143-71, 62332-143-10, 2405014780
Code info: Batch 2405014780, Exp. Date: Sep. 30, 2027

Affected areas

Nationwide

Timeline

  1. Initiated
    May 9, 2025
  2. Published
    Jun 18, 2025
Recall number
D-0459-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.