Celecoxib 200 mg Capsules Recalled Due to Foreign Tadalafil Tablet Contamination
AvKARE recalled 3,817 cartons of Celecoxib 200 mg capsules nationwide because one tadalafil 5 mg tablet was found mixed into the product. The contamination poses a risk of medication error if patients unknowingly take the wrong drug.
What this means for you
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 pharmaceutical contamination recall with no reported illnesses or injuries. However, having the wrong medication mixed into a prescription drug product creates a serious risk of medication error and potential adverse drug effects. Per the rubric, risk-of-harm products without reported injury score at 3 (High).
Plain-English summary
AvKARE is recalling 3,817 cartons of Celecoxib 200 mg capsules nationwide. The recalled product is Lot #47881 with expiration date 05/31/2026, packaged as 50-count cartons.
During quality control, one tadalafil 5 mg tablet was discovered mixed into Celecoxib product. Tadalafil is a different medication used to treat erectile dysfunction, while Celecoxib is a nonsteroidal anti-inflammatory drug used for pain and inflammation. The presence of the wrong medication poses a significant risk of medication error if patients unknowingly take the tadalafil instead of their intended Celecoxib dose.
Consumers who have purchased Celecoxib 200 mg capsules from this recall (Lot #47881) should stop using the product immediately and contact their pharmacy or AvKARE. If you have already taken doses from an affected carton, consult a healthcare provider. The product can be identified by Lot #47881 and NDC number 50268-169-15.
The recalled product
- Product
- CELECOXIB (CELECOXIB)
- Brand
- CELECOXIB
- Manufacturer
- AvKARE
- Hazard
- drug-contamination
- wrong-medication
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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