Celecoxib Capsules 200 mg recalled for foreign tablets inside bottles
Alembic Pharmaceuticals is recalling Celecoxib 200 mg capsules after a customer found a Tadalafil 5 mg tablet inside a sealed 500-count bottle. The contamination was discovered through a customer complaint.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class II recall involving a foreign object (unapproved medication) in a sealed prescription drug container presents a significant contamination issue that could result in unintended drug ingestion and potential patient harm, meeting the criteria for Severe classification.
Plain-English summary
Alembic Pharmaceuticals Limited is recalling Celecoxib Capsules, 200 mg, because a customer complaint identified a Tadalafil 5 mg tablet inside a sealed 500-count bottle. The affected product is batch 2405014780 with an expiration date of September 30, 2027, distributed nationwide and in Puerto Rico.
The presence of a foreign tablet in a sealed container presents a safety risk. Consumers who have this product and suspect they may have received contaminated bottles should stop using it and contact their pharmacy or healthcare provider.
Patients taking this medication should not stop treatment without consulting their healthcare provider. If you have the recalled batch number, contact Alembic Pharmaceuticals or your pharmacy for instructions on how to proceed.
The recalled product
- 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
- Manufacturer
- Alembic Pharmaceuticals Limited
- Category
- Drug — Prescription / NSAID
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Batch 2405014780
- Exp. Date: Sep. 30
- 2027
Distribution
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