The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0375-2023·Announced 2023-03-08

Buspirone Hydrochloride tablets recalled for manufacturing practice deviations

Accord Healthcare is recalling Buspirone Hydrochloride 7.5 mg tablets (23,784 bottles) distributed in the US, Puerto Rico, and Canada due to manufacturing practice deviations identified during 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This recall is classified as FDA Class II with no reported illnesses or injuries and manufacturing practice deviations identified during inspection. Per the severity rubric, precautionary recalls with theoretical hazards and no adverse events are rated Moderate (2).

Plain-English summary

Accord Healthcare, Inc. is recalling certain Buspirone Hydrochloride Tablets USP 7.5 mg that were distributed in the United States, including Puerto Rico and Canada. The product was manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India, and packaged in 100-count bottles.

The recall affects approximately 23,784 bottles with the following batch numbers and expiration dates: Batch P2105532 (expiration 6/30/2024) and Batch P2200348 (expiration 12/31/2024).

The recall was initiated following an FDA inspection that identified deviations from Current Good Manufacturing Practice (CGMP) standards. No illnesses or injuries associated with this product have been reported.

The recalled product

Product
BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Brand
BUSPIRONE HYDROCHLORIDE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Prescription / Manufacturing
Hazard
Affected units
23,784

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 (4)

  • Batches: P2105532
  • Exp. Date 6/30/2024
  • P2200348
  • Exp. Date 12/31/2024

UPCs (1)

  • 0316729289016

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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