CLASS II Drug recall · Reported 9 Jun 2021 · FDA Enforcement Report
BusPIRone Hydrochloride Tablets, USP, 15 mg recalled
Oxford Pharmaceuticals is recalling BusPIRone Hydrochloride Tablets, USP, 15 mg, distributed nationwide in the US. The recall was initiated on 5 May 2021 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-0602-2021
- FDA event ID
- 87873
- Recalling firm
- Oxford Pharmaceuticals, Birmingham, AL
- Manufacturer
- Oxford Pharmaceuticals, LLC
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 5 May 2021
- FDA classified
- 2 Jun 2021
- Reported
- 9 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Anxiety & Sleep Medication
Timeline
| 5 May 2021 | Recall initiated by company | |
| 2 Jun 2021 | Classified by FDA | +28 days |
| 9 Jun 2021 | 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
Presence of Foreign Tablets/Capsules
Product as listed by the FDA
BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10
Where it was distributed
USA Nationwide.
Questions about this recall
Is BusPIRone Hydrochloride Tablets, USP, 15 mg recalled?
Yes. Oxford Pharmaceuticals recalled BusPIRone Hydrochloride Tablets, USP, 15 mg on 5 May 2021. The recall is Class II and its status is Completed. Recall number D-0602-2021.
Why was it recalled?
Presence of Foreign Tablets/Capsules
Which lots are affected?
Lot #: C21021A, Exp. 03/2023
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 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 21 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 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, 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 |