CLASS II ONGOING Drug recall · Reported 3 May 2023 · FDA Enforcement Report
BusPIRone Hydrochloride Tablets USP, 7.5 mg recalled
Northwind Pharmaceuticals is recalling BusPIRone Hydrochloride Tablets USP, 7.5 mg, distributed nationwide in the US. The recall was initiated on 16 Mar 2023 and the FDA has classified it as Class II.
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-0549-2023
- FDA event ID
- 91944
- Recalling firm
- Northwind Pharmaceuticals, Indianapolis, IN
- Manufacturer
- Northwind Health Company, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Mar 2023
- FDA classified
- 26 Apr 2023
- Reported
- 3 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Anxiety & Sleep Medication
Timeline
| 16 Mar 2023 | Recall initiated by company | |
| 26 Apr 2023 | Classified by FDA | +41 days |
| 3 May 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52
Where it was distributed
Nationwide with the United States
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot#: F117312201, Exp. Date 06/30/2024
Where was it sold?
Nationwide with the United States
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
6 other products · FDA event 91944This product is part of a recall event; the main page for the event is Tadalafil Tablets, USP 20 mg recalled by Northwind Pharmaceuticals.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Tadalafil Tablets, USP 20 mg recalled by Northwind PharmaceuticalsTadalafil | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Glimepiride Tablets, USP 2mg recalled by Northwind PharmaceuticalsGlimepiride | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Atorvastatin Calcium Tablets, USP, 10 mg recalledAtorvastatin Calcium | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Doxazosin Tablets, USP, 4mg recalled by Northwind PharmaceuticalsDoxazosin | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Tadalafil Tablets, USP 5 mg recalled by Northwind PharmaceuticalsTadalafil | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Glimepiride Tablets, USP 4mg recalled by Northwind PharmaceuticalsGlimepiride | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Northwind Pharmaceuticals
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim Tablets recalledSulfamethoxazole And Trimethoprim | Northwind Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Glimepiride Tablets, USP 4mg recalled by Northwind PharmaceuticalsGlimepiride | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Tadalafil Tablets, USP 5 mg recalled by Northwind PharmaceuticalsTadalafil | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Doxazosin Tablets, USP, 4mg recalled by Northwind PharmaceuticalsDoxazosin | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Atorvastatin Calcium Tablets, USP, 10 mg recalledAtorvastatin Calcium | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
Other Buspirone recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | busPIRone Hydrochloride Tablets, USP, 5 mg recalledBuspirone Hydrochloride | Unichem Pharmaceuticals USA | Potency & Assay | Nationwide |
| 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 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 |