Zydus Recalls Acyclovir Tablets Due to Labeling Error with Carvedilol
Zydus Pharmaceuticals is recalling Acyclovir 400 mg tablets because one bottle was found to contain Carvedilol 6.25 mg tablets due to a label mix-up.
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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or adverse health consequences (such as taking the wrong medication) are rated as Severe (4).
Plain-English summary
Zydus Pharmaceuticals USA Inc is recalling Acyclovir Tablets, USP, 400 mg, 100 count bottles. The recall was initiated after a report indicated that one bottle labeled as Acyclovir 400 mg actually contained Carvedilol Tablets 6.25 mg. This error is attributed to a labeling mix-up.
The affected product is manufactured by Cadila Healthcare Ltd. in India and distributed by Zydus Pharmaceuticals (USA) Inc. in Pennington, NJ. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for Acyclovir 400 mg tablets with NDC 68382-791-01 or related NDCs listed in the recall notice. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have taken the medication and experience any unexpected symptoms.
The recalled product
- Product
- ACYCLOVIR (ACYCLOVIR)
- Brand
- ACYCLOVIR
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Drug
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
- 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 →Related recalls
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