The Recall Desk
HighFDA (Drugs)·D-0602-2021·Announced 2021-06-09

Buspirone Hydrochloride Tablets Recalled for Foreign Tablet Contamination

Oxford Pharmaceuticals is recalling 6,864 bottles of Buspirone Hydrochloride Tablets, 15 mg, distributed nationwide due to the presence of foreign tablets or capsules in the product.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving foreign tablet contamination in a prescription medication, creating a risk of patient harm through unintended drug exposure. Although no reported illnesses or injuries are stated in the source text, the hazard is significant and involves risk of administering an unknown substance to patients.

Plain-English summary

Oxford Pharmaceuticals, LLC is recalling Buspirone Hydrochloride Tablets, USP, 15 mg, 100-count bottles (Lot #C21021A, expiration 03/2023, NDC 69584-093-10) distributed nationwide. Approximately 6,864 bottles are affected by this recall.

The recall is due to the presence of foreign tablets or capsules in the product. This contamination could result in patients receiving unintended medication.

Patients taking this product should discontinue use and contact their pharmacy or healthcare provider. Consumers who have this medication should return it to the place of purchase or contact Oxford Pharmaceuticals for further instructions.

The recalled product

Product
BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Brand
BUSPIRONE HYDROCHLORIDE
Manufacturer
Oxford Pharmaceuticals, LLC
Hazard
  • foreign-tablet-contamination
  • product-contamination
  • wrong-medication-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: C21021A
  • Exp. 03/2023

UPCs (1)

  • 0369584093502

Distribution

Distributed nationwide across the United States.