Celecoxib Capsules Recalled for Foreign Tablet Contamination
AvKARE is recalling Celecoxib 200 mg capsules because one tadalafil 5 mg tablet was found in a 500-count bottle. The contamination poses a risk of unintended drug exposure to patients.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving contamination by a foreign drug substance. Although no illnesses or injuries have been reported in the source text, the presence of an unintended medication in a prescription drug bottle creates a risk of significant harm from medication error, placing it in the "High" category per the rubric's criterion for risk-of-harm products.
Plain-English summary
AvKARE is recalling Celecoxib 200 mg capsules (NDC 50268-169-15, Lot #47881, expiration 05/31/2026) nationwide in the USA. The recall was initiated after one tadalafil 5 mg tablet was discovered in a 500-count bottle of the celecoxib capsules.
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to reduce pain and inflammation. Tadalafil is a different medication with a different therapeutic purpose. The presence of a tadalafil tablet in a celecoxib bottle creates a risk that a patient may unknowingly take the wrong medication.
Affected customers who have this product should stop using it and contact their pharmacy or healthcare provider. Patients should not dispose of the medication in household trash or water; they should use a medication take-back program or follow FDA disposal guidelines.
The recalled product
- Product
- CELECOXIB (CELECOXIB)
- Brand
- CELECOXIB
- Manufacturer
- AvKARE
- 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 (2)
- Lot #47881
- Exp 05/31/2026
Distribution
Distributed nationwide across the United States.
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