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.
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: 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
- 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.
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