CLASS II Drug recall · Reported 2 Sep 2020 · FDA Enforcement Report
BusPIRone Hydrochloride Tablets, USP 7.5 mg recalled
Par Pharmaceutical is recalling BusPIRone Hydrochloride Tablets, USP 7.5 mg, distributed nationwide in the US. The recall was initiated on 10 Aug 2020 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-1542-2020
- FDA event ID
- 86202
- Recalling firm
- Par Pharmaceutical, Chestnut Ridge, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Aug 2020
- FDA classified
- 25 Aug 2020
- Reported
- 2 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Anxiety & Sleep Medication
Timeline
| 10 Aug 2020 | Recall initiated by company | |
| 25 Aug 2020 | Classified by FDA | +15 days |
| 2 Sep 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurity /Degradation Specifications
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 7.5 mg NDC# 49884-725-01
Where it was distributed
Product was distributed to 9 major distributors throughout the United States.
Questions about this recall
Why was it recalled?
Failed Impurity /Degradation Specifications
Which lots are affected?
Lot # 32091002, exp. date May 2021
Where was it sold?
Product was distributed to 9 major distributors throughout 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.
More recalls from Par Pharmaceutical
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Glycopyrrolate Tablets, USP 1 mg recalled by Par Pharmaceutical | Par Pharmaceutical | Potency & Assay | NY |
| Drug | CLASS III | PrediniSONE Tablets, USP 5 mg recalled by Par PharmaceuticalPrednisone | Par Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Frovatriptan Succinate Tablets, 2.5mg recalled by Par Pharmaceutical | Par Pharmaceutical | Labeling Errors | Nationwide |
| Drug | CLASS I | Mycophenolate Mofetil for Injection, USP 500 mg Dose Vials recalledMycophenolate Mofetil | Par Pharmaceutical | Particulate Matter | Nationwide |
| Drug | CLASS III | Pramipexole dihydrochloride extended release tablets, 0.75 mg recalled | Par Pharmaceutical | Potency & Assay | 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, 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 |