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.
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 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
Same brand · ACYCLOVIR
- LowHeritage Pharmaceuticals Recalls Acyclovir Tablets Due to Labeling Errors
FDA (Drugs) · 2021-05-12
- SevereZydus Recalls Acyclovir Sodium Injection Due to Crystallization
FDA (Drugs) · 2021-04-07
- SevereZydus Recalls Acyclovir Sodium Injection Due to Crystallization
FDA (Drugs) · 2021-04-07
- SevereAcyclovir Tablets Recalled Due to Presence of Torsemide Tablets
FDA (Drugs) · 2018-03-07
- LowHetero USA Recalls Acyclovir Tablets Due to Human Hair Presence
FDA (Drugs) · 2017-06-14
Same manufacturer · Zydus Pharmaceuticals USA Inc
See all →- SevereFDA Recalls Mirabegron Tablets Over Nitrosamine Impurity
FDA (Drugs) · 2026-08-12
- SevereErythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
- SevereErythromycin 500 mg Tablets Recalled for Impurity Above Limits
FDA (Drugs) · 2026-05-27
- HighIcosapent ethyl capsules recalled after active ingredient oxidized inside capsule
FDA (Drugs) · 2026-03-18
- HighIcosapent ethyl capsules recalled as subpotent after capsule contents leaked
FDA (Drugs) · 2026-01-28
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02