Zydus Pharmaceuticals USA Inc recalls Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed
Zydus Pharmaceuticals USA recalls 400mg Acyclovir tablets due to label mix-up with Carvedilol tablets. Affected bottles may contain incorrect medication. Contact for details.
Recall notice
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Contact the company & request your remedy
What happened, in plain English
Zydus Pharmaceuticals is recalling 100-count bottles of Acyclovir Tablets (400mg) because some bottles were mislabeled and contain Carvedilol instead. This could lead to incorrect medication use if taken without knowing the actual contents. Read more at govinfonow.com/recall/38873-zydus-acyclovir-tablets-400mg-recall-label-mix-up-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38873-zydus-acyclovir-tablets-400mg-recall-label-mix-up-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1272-2019
Cite this page
“Zydus Acyclovir Tablets 400mg Recall: Label Mix-Up Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38873-zydus-acyclovir-tablets-400mg-recall-label-mix-up-risk. Based on FDA recall #D-1272-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1272-2019%22&limit=1).
Why it’s dangerous
The recall is for a labeling error where some bottles of Acyclovir Tablets were mistakenly labeled as Acyclovir but actually contained Carvedilol Tablets. Carvedilol is a different medication with its own risks and uses, so taking it instead of Acyclovir could cause harm.
Who’s affected
People with prescriptions for Acyclovir Tablets 400mg from Zydus Pharmaceuticals. Those who have the specific bottle with NDC 68382-791-01 are most at risk.
How to tell if you have this one
Check for the NDC code 68382-791-01 on the bottle. The product was distributed by Zydus Pharmaceuticals in the US starting November 30, 2020.
- Brand
Zydus Pharmaceuticals- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-1272-2019 | Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-791-01; Z804517, Nov 30, 2020 | N/A | 68382-791-06, 68382-791-16, 68382-791-01, 68382-791-05, 68382-791-10, 68382-791-30, 68382-792-06, 68382-792-16, 68382-792-01, 68382-792-05, 68382-792-10, 68382-792-30 |
| D-1273-2019 | Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05; Z804517, exp Nov 30, 2020 | 3900 | 68382-092-17, 68382-092-01, 68382-092-05, 68382-093-17, 68382-093-05, 68382-093-01, 68382-094-17, 68382-094-01, 68382-094-05, 68382-095-17, 68382-095-01, 68382-095-05 |
What to do — step by step
Check Product Label
Look for the NDC code 68382-791-01 on the bottle to confirm it's the recalled item.
Questions people ask
Is this product safe to use?
The recall indicates a potential mix-up with Carvedilol, which is a different medication. Do not use the product if you're unsure of its contents.
How can I tell if I have the recalled product?
Check for the NDC code 68382-791-01 on the bottle. The product was distributed by Zydus Pharmaceuticals starting November 30, 2020.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact Zydus Pharmaceuticals for guidance.
Contact Zydus Pharmaceuticals
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1272-2019 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-1272-2019 from Zydus Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1272-2019 (April 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1272-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.