CLASS III ONGOING Drug recall · Reported 13 May 2026 · FDA Enforcement Report
busPIRone Hydrochloride Tablets, USP, 5 mg recalled
Unichem Pharmaceuticals USA is recalling busPIRone Hydrochloride Tablets, USP, 5 mg, distributed nationwide in the US. The recall was initiated on 13 Apr 2026 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0511-2026
- FDA event ID
- 98728
- Recalling firm
- Unichem Pharmaceuticals USA, East Brunswick, NJ
- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 13 Apr 2026
- FDA classified
- 1 May 2026
- Reported
- 13 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Anxiety & Sleep Medication
Timeline
| 13 Apr 2026 | Recall initiated by company | |
| 1 May 2026 | Classified by FDA | +18 days |
| 13 May 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Subpotent drug
Which lots are affected?
Lot: ZBUL25001, Exp 12/31/2027
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Unichem Pharmaceuticals USA
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Doxazosin Tablets, USP, 4 mg recalled by Unichem Pharmaceuticals USADoxazosin Mesylate | Unichem Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Bisoprolol Fumarate and Hydrochlorothiazide tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Unichem Pharmaceuticals USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS I | Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg recalledCyclobenzaprine Hydrochloride | Unichem Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS III | Clonidine Hydrochloride Tablets, USP, 0.3 mg recalledClonidine Hydrochloride | Unichem Pharmaceuticals USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Topiramate Tablets, USP 50 mg recalled by Unichem Pharmaceuticals UsaTopiramate | Unichem Pharmaceuticals USA | Other | Nationwide |
Other Buspirone recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Buspirone Hydrochloride Tabs USP 10 mg recalledBuspirone Hydrochloride | NCS Healthcare of Kentucky | Packaging Defects | Nationwide |
| Drug | CLASS III | Lisinopril Tablets USP 20 mg recalled by NCS Healthcare of KentuckyBuspirone Hydrochloride | NCS Healthcare of Kentucky | Packaging Defects | Nationwide |
| Drug | CLASS II | BusPIRone Hydrochloride Tablets USP, 7.5 mg recalledBuspirone Hydrochloride | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | BusPIRone Hydrochloride Tablets USP 15 mg recalled by Accord HealthcareBuspirone Hydrochloride | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS II | BusPIRone Hydrochloride Tablets USP 7.5 mg recalled by Accord HealthcareBuspirone Hydrochloride | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |