Par Pharmaceutical Inc. recalls BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Par Pharmaceutical recalls BusPIRone Hydrochloride 7.5mg tablets (NDC 49884-725-01) due to failed impurity specifications. This may pose a risk of harmful impurities in the medication.
Recall notice
Failed Impurity /Degradation Specifications
Contact the company & request your remedy
What happened, in plain English
Par Pharmaceutical is recalling BusPIRone Hydrochlor:ide 7.5mg tablets (NDC 49884-725-01) because they failed impurity and degradation tests. This could mean the medication contains harmful substances that might affect your health. Read more at govinfonow.com/recall/36844-par-pharmaceutical-buspirone-hydrochloride-tablets-7-5mg-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36844-par-pharmaceutical-buspirone-hydrochloride-tablets-7-5mg-recall-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1542-2020
Cite this page
“Par Pharmaceutical BusPIRone Hydrochloride Tablets 7.5mg Recall: Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/36844-par-pharmaceutical-buspirone-hydrochloride-tablets-7-5mg-recall-impurity-risk. 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 tablets failed impurity and degradation specifications, meaning they may contain harmful substances that could affect your health. This is a chemical issue with the medication's quality control.
Who’s affected
People who have the specific 7.5mg BusPIRone Hydrochloride tablets with NDC 498884-725-01 and lot number 32091002 are affected. Those taking this medication for medical reasons are at risk.
How to tell if you have this one
Check for the product name 'BusPIRone Hydrochloride Tablets, USP 7.5 mg' and the NDC number 49884-725-01. The lot number 32091002 and expiration date May 2021 are also specific identifiers for this recall.
- Brand
Par Pharmaceutical- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC number 49884-725-01 and lot number 32091002 on the tablet packaging.
Questions people ask
Is this medication safe to take?
The recall states the tablets failed impurity and degradation specifications, so they may contain harmful substances. Do not take these tablets until you contact the manufacturer.
What should I do if I have these tablets?
The recall does not specify a remedy, so contact Par Pharmaceutical directly for guidance on what to do with the medication.
How can I confirm if my tablets are recalled?
Check the NDC number 49884-725-01 and lot number 32091002 on the packaging to confirm if your tablets are part of this recall.
Contact Par Pharmaceutical
We’ve drafted a message you can send Par Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-1542-2020 — Par Pharmaceutical Par Pharmaceutical Hello, I own a Par Pharmaceutical that is covered by recall D-1542-2020 from Par Pharmaceutical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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 qwen3:4b on October 5, 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.