The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0549-2023·Announced 2023-05-03

Drug Recall: Buspirone Tablets Over Manufacturing Process Deviations

Northwind Pharmaceuticals is recalling Buspirone Hydrochloride 7.5 mg tablets due to manufacturing process deviations. The FDA Class II recall affects bottles distributed nationwide.

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: FDA Class II recall with no reported illnesses or injuries. CGMP deviations without specific adverse events constitute a voluntary precautionary recall, which the rubric classifies as Moderate severity.

Plain-English summary

Northwind Pharmaceuticals LLC is recalling Buspirone Hydrochloride Tablets USP, 7.5 mg, supplied in 30-count bottles, NDC 51655-511-52. The FDA classified this as a Class II recall due to Current Good Manufacturing Practice (CGMP) deviations.

The affected product was distributed nationwide across the United States. The recall involves six bottles with lot number F117312201 and expiration date of June 30, 2024.

The recall was initiated voluntarily by Northwind Pharmaceuticals on March 16, 2023. The company notified customers through multiple channels including email, fax, letter, press release, telephone, and direct visits.

The recalled product

Product
BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Brand
BUSPIRONE HYDROCHLORIDE
Manufacturer
Northwind Pharmaceuticals LLC
Category
Drug
Hazard
Affected units
6

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#: F117312201
  • Exp. Date 06/30/2024

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Northwind Pharmaceuticals LLC 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 7 products in this recall →

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