Par Pharma Recalls BusPIRone Tablets Due to Impurity Issues
Par Pharmaceutical recalls 11,347 bottles of BusPIRone Hydrochloride Tablets 7.5 mg due to failed impurity specifications. Check your lot number.
Recall notice
Failed Impurity /Degradation Specifications
Contact the company
What happened, in plain English
Par Pharmaceutical Inc. is recalling one lot of BusPIRone Hydrochloride Tablets, USP 7.5 mg because the product failed impurity and degradation specifications. The affected batch consists of 11,347 bottles distributed to major distributors across the United States. The record does not specify what actions consumers should take or if the medication is unsafe to use. Read more at govinfonow.com/recall/36844-par-pharma-recalls-buspirone-tablets-due-to-impurity-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/36844-par-pharma-recalls-buspirone-tablets-due-to-impurity-issues · Updated October 11, 2026 · FDA enforcement record: FDA #D-1542-2020
Cite this page
“Par Pharma Recalls BusPIRone Tablets Due to Impurity Issues.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36844-par-pharma-recalls-buspirone-tablets-due-to-impurity-issues. Based on FDA recall #D-1542-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1542-2020%22&limit=1).
Why it’s dangerous
The recall was issued because the tablets failed impurity and degradation specifications. The provided record does not explain what these impurities are or how they might affect patient safety.
Who’s affected
Individuals who were prescribed BusPIRone Hydrochloride Tablets 7.5 mg and purchased them from major distributors in the United States before August 10, 2020. The specific risk to health is not described in the provided record.
How to tell if you have this one
Check your medication bottle for NDC# 49884-725-01 and Lot # 32091002 with an expiration date of May 2021. The product was distributed to nine major distributors throughout the United States.
- Brand
Par Pharmaceutical- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed to 9 major distributors throughout the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1542-2020 (August 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1542-2020 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.