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Class III: unlikely to cause harmOngoing

Unichem Pharmaceuticals busPIRone Hydrochloride Tablets Recall

busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by…

Unichem Pharmaceuticals USA Inc. · East Brunswick, NJ

Risk level
Class III
Reported by FDA
May 13, 2026
Recall ID
D-0511-2026
Check your lot numberHow we source this data

Summary

Unichem Pharmaceuticals recalled busPIRone Hydrochloride Tablets starting Apr 13, 2026. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0511-2026 on May 13, 2026. Reason: Subpotent drug. Status: Ongoing.

Why it was recalled

Subpotent drug

Product description

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.

Lot numbers, UPCs & expiration codes

Lot: ZBUL25001, Exp 12/31/2027

Where it was sold

USA Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0511-2026
Classification
Class III
Status
Ongoing
Recall initiated
Apr 13, 2026
FDA report date
May 13, 2026
Quantity
10,875 Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Unichem Pharmaceuticals USA Inc.

Original FDA data

Every field from FDA enforcement report D-0511-2026, exactly as published.

Show all FDA fields
City
East Brunswick
State
NJ
Status
Ongoing
Country
United States
Event ID
98728
Address
1 Tower Center Blvd Ste 2200
Code information
Lot: ZBUL25001, Exp 12/31/2027
Postal code
08816-1145
Report date
May 13, 2026
Product type
Drugs
Recall number
D-0511-2026
Classification
Class III
Recalling firm
Unichem Pharmaceuticals USA Inc.
Product quantity
10,875 Bottles
Reason for recall
Subpotent drug
Voluntary / mandated
Voluntary: Firm initiated
Product description
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.
Distribution pattern
USA Nationwide
Recall initiation date
Apr 13, 2026
Initial firm notification
Letter
Center classification date
May 1, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0511-2026, published May 13, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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