The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0379-2023·Announced 2023-03-08

FDA recalls Buspirone Hydrochloride tablets for manufacturing practice deviations

Accord Healthcare is recalling approximately 25,812 bottles of Buspirone Hydrochloride 30mg tablets due to manufacturing practice deviations discovered during an FDA inspection.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 FDA Class II recall is driven by manufacturing practice deviations without documented illnesses or injuries. Per the rubric, this represents a High (3) severity rating as it is a risk-of-harm scenario without reported injury.

Plain-English summary

Accord Healthcare, Inc. is recalling Buspirone Hydrochloride Tablets USP 30 mg in 60-count bottles (NDC 16729-289-12, batch P2105551, expiration July 31, 2024) due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection.

Approximately 25,812 bottles have been affected. The recalled product was distributed throughout the United States, including Puerto Rico and Canada.

Consumers in possession of the recalled medication should contact their healthcare provider or pharmacist for guidance. Do not stop taking the medication or discard it without consulting a healthcare provider.

The recalled product

Product
BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Brand
BUSPIRONE HYDROCHLORIDE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Antianxiety
Hazard
Affected units
25,812

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)

  • Batches: P2105551
  • Exp. Date 7/31/2024

UPCs (2)

  • 0316729289016
  • 316729289122

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 67 recalled by Accord Healthcare, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 67 products in this recall →

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