Carvedilol Tablets Recalled for Foreign Paroxetine Tablets
Zydus Pharmaceuticals is recalling Carvedilol 25 mg tablets nationwide after Paroxetine tablets were found mixed into bottles. Patients should not take affected bottles and contact their pharmacy or doctor.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is a Class II recall involving foreign medication mixed into prescription drug bottles—a serious labeling/packaging defect with clear potential for patient harm. While no illness has been reported, the medication mix-up creates significant risk of adverse drug events in patients with heart conditions taking the wrong medication.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling Carvedilol (Carvedilol) Tablets, USP 25 mg in 500-tablet bottles due to the presence of foreign tablets. Two Paroxetine tablets were found in an affected bottle, creating a serious mix-up in medication.
The recalled product is distributed nationwide in the United States. The affected bottles are identified by lot code Z006279 with an expiration date of 12/31/2022. Approximately 2,880 bottles were distributed.
Patients taking Carvedilol from the recalled lot should stop use immediately and contact their pharmacy or healthcare provider. Carvedilol is used to treat heart conditions, and taking Paroxetine instead or in addition could cause serious health consequences. Consumers should not take tablets from the affected bottles and should return them to their pharmacy for proper handling.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Prescription - Cardiac
- Hazard
- foreign-medication-contamination
- mis-dispensing-risk
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)
- Z006279
- exp 12/31/2022
Distribution
Distributed nationwide across the United States.
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