Agency classClass IIOur severity:Severe FDA (Drugs)·D-0753-2021·Announced 2021-08-25

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.

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: 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
Affected units: 2,880

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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