Agency classClass IIOur severity:Severe FDA (Drugs)·D-1273-2019·Announced 2019-05-15

Zydus Recalls Carvedilol Tablets Due to Labeling Mix-Up

Zydus Pharmaceuticals is recalling Carvedilol 6.25 mg tablets because one bottle was found labeled as Acyclovir 400 mg.

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: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly given the risk of administering the wrong medication.

Plain-English summary

Zydus Pharmaceuticals USA Inc. is recalling Carvedilol Tablets, USP, 6.25 mg, 500 count bottles. The recall is due to a labeling mix-up where a report was received of one bottle labeled as Acyclovir Tablets USP 400 mg actually containing Carvedilol Tablets 6.25 mg.

The affected product is identified by lot code Z804517 and has an expiration date of November 30, 2020. The product was distributed nationwide. The total quantity involved in the recall is 3,900 units.

Consumers should check their medication for the specific lot code and expiration date. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.

The recalled product

Product: CARVEDILOL (CARVEDILOL)
Brand: CARVEDILOL
Manufacturer: Zydus Pharmaceuticals USA Inc
Category: Drug — Prescription Drug
Hazard: mis-labeling
wrong-medication
Affected units: 3,900

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)

Z804517
exp Nov 30
2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Zydus Pharmaceuticals USA Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same brand · CARVEDILOL

High
Major Pharmaceuticals carvedilol tablets recalled over nitrosamine impurity above FDA limit
FDA (Drugs) · 2025-08-27
High
Carvedilol 12.5 mg tablets recalled over nitrosamine above acceptable intake level
FDA (Drugs) · 2025-08-20
High
Carvedilol 3.125 mg tablets recalled for nitrosamine impurity above intake limit
FDA (Drugs) · 2025-08-20
High
Carvedilol 25 mg tablets recalled over nitrosamine impurity above FDA limit
FDA (Drugs) · 2025-08-20
High
Glenmark carvedilol 12.5 mg tablets exceed the nitrosamine impurity limit
FDA (Drugs) · 2025-08-20

Same manufacturer · Zydus Pharmaceuticals USA Inc

See all →

Severe
FDA Recalls Mirabegron Tablets Over Nitrosamine Impurity
FDA (Drugs) · 2026-08-12
Severe
Erythromycin 500 mg Tablets Recalled for Impurity Above Limits
FDA (Drugs) · 2026-05-27
Severe
Erythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
High
Icosapent ethyl capsules recalled after active ingredient oxidized inside capsule
FDA (Drugs) · 2026-03-18
High
Icosapent ethyl capsules recalled as subpotent after capsule contents leaked
FDA (Drugs) · 2026-01-28

Same hazard · mis labeling