Class II U.S. Food and Drug Administration

Zydus Pharmaceuticals Inc Entecavir Tablets, USP, 1 mg, 30 Tablets recall: Failed Impurity/Degradation Specifications

Recall published 1+ years ago

Failed Impurity/Degradation Specifications

The hazard: Potency, impurity or stability failure

An out-of-specification result prompted this notice — potency, an impurity, or stability over the shelf life.

What the notice says: Failed Impurity/Degradation Specifications

Why it matters: The product failed a specification test: it may contain more or less active ingredient than the label states, carry an impurity, or degrade before its expiry date. A sub-potent dose can leave a condition untreated; a super-potent one can cause an overdose.

Symptoms and when to call a doctor

The risk depends entirely on the drug. For a medicine where dose matters closely — a blood thinner, an anti-epileptic, a thyroid or heart medicine, insulin — talk to your prescriber before changing anything. Seek urgent care if you have symptoms that suggest too much drug, or if the condition the medicine controls starts breaking through.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0657-2025
Published
September 24, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Zydus Pharmaceuticals Inc
Product type
Prescription & OTC drugs
Units affected
4440 bottles
Distribution
Nationwide
Made in
United States
Lot / code info
Lot E309377, Exp 11/30/2025

Products covered by this recall

Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • E309377
  • Exp 11
  • 30
  • 2025 — 4440 bottles

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 11
  • 30
  • 2025 — 4440 bottles

NDC number

On the carton and again on the bottle or blister label.

  • 68382-921-06

Package size

Match the net weight or the piece count on the front of the pack.

  • 1 mg

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Potency

Zydus Pharmaceuticals Inc — An out-of-specification result prompted this notice — potency, an impurity, or stability over the shelf life.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Do not stop a prescription on your own. For most conditions an uncertain dose is safer than no dose while you get advice.
  3. Call your prescriber or pharmacist and ask whether to swap the lot, re-test, or change nothing.
  4. Keep the carton and the leaflet — the lot number is usually printed only on the outer pack.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Zydus Pharmaceuticals (USA) Inc — 73 Route 31 N, Pennington, NJ, 08534-3601

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Zydus Pharmaceuticals Inc prescription & otc drugs recalled?

Failed Impurity/Degradation Specifications Failed Impurity/Degradation Specifications

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code E309377, Exp 11, 30; best-by date 11 or 30. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above before you do anything else.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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