Class III U.S. Food and Drug Administration

Unichem Pharmaceuticals USA Inc. busPIRone Hydrochloride Tablets, USP recall: Subpotent drug

Recall published 6 months ago

Subpotent drug

The hazard: Potency, impurity or stability failure

This is a specification failure: testing showed the product does not match what the label promises.

What the notice says: Subpotent drug

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-0511-2026
Published
May 13, 2026
Risk level
Class III
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Unichem Pharmaceuticals USA Inc.
Product type
Prescription & OTC drugs
Units affected
10,875 Bottles
Distribution
Nationwide
Made in
United States
Lot / code info
Lot: ZBUL25001, Exp 12/31/2027

Products covered by this recall

busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.

Check your product

The notice names 12 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.

  • ZBUL25001
  • Exp 12
  • 31
  • 2027 — 10
  • 875 Bottles

Best-by / use-by date

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

  • 12
  • 31
  • 2027 — 10
  • 875 Bottles

NDC number

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

  • 29300-244-05

Package size

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

  • 5 mg
  • 500 count

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

Unichem Pharmaceuticals USA Inc. — This is a specification failure: testing showed the product does not match what the label promises.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Keep the carton and the leaflet — the lot number is usually printed only on the outer pack.
  3. Report any change in how the medicine is working to FDA MedWatch, which is where most of these signals originate.
  4. Do not stop a prescription on your own. For most conditions an uncertain dose is safer than no dose while you get advice.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Unichem Pharmaceuticals USA Inc. — 1 Tower Center Blvd Ste 2200, East Brunswick, NJ, 08816-1145

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 Unichem Pharmaceuticals USA Inc. prescription & otc drugs recalled?

Subpotent drug Subpotent drug

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code ZBUL25001, Exp 12, 31; best-by date 12 or 31. 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?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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