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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Oxford Pharmaceuticals, LLC: BusPIRone Hydrochloride Tablets Recalled for Foreign Tablets/Capsules

Agency Publication Date: June 2, 2021
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Summary

Oxford Pharmaceuticals, LLC is recalling 6,864 bottles of BusPIRone Hydrochloride Tablets, USP, 15 mg (generic Buspar), a prescription medication used to treat anxiety. The recall was initiated because of the presence of foreign tablets or capsules found within the medication bottles. If you have a 100-count bottle from the affected lot, you should contact your healthcare provider or pharmacist immediately for guidance and return the product to your pharmacy.

Risk

The presence of foreign tablets or capsules in a prescription bottle can lead to the accidental ingestion of the wrong medication. This poses a risk of adverse drug reactions or serious health complications depending on the identity of the unintended medication and the patient's underlying health conditions.

What You Should Do

  1. Check your medication bottle for BusPIRone Hydrochloride Tablets, USP, 15 mg in 100-count bottles with NDC 69584-093-10.
  2. Verify if your bottle belongs to Lot C21021A with an expiration date of 03/2023.
  3. If your bottle matches these identifiers, contact your healthcare provider or pharmacist immediately to discuss your treatment and for guidance on how to handle the medication.
  4. Return any unused portion of the affected medication to the pharmacy where it was purchased for a refund.
  5. Contact Oxford Pharmaceuticals, LLC at 301 Leaf Lake Pkwy, Birmingham, Alabama, for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: BusPIRone Hydrochloride Tablets, USP, 15 mg (100-count bottle)
Model:
NDC 69584-093-10
Lot Numbers:
C21021A (Exp. 03/2023)
Date Ranges: 03/2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87873
Status: Resolved
Manufacturer: Oxford Pharmaceuticals, LLC
Sold By: Retail Pharmacies
Manufactured In: United States
Units Affected: 6,864 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.