The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0558-2022·Announced 2022-02-23

Diazepam Oral Solution Recalled for Failed Impurity Specifications

Lannett Company is recalling Diazepam Oral Solution (Concentrate) 5 mg/mL due to out-of-specification results for related substances, indicating failed impurities and degradation testing.

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 is an FDA Class II recall involving a drug quality defect (failed impurity/degradation specifications). No illnesses or injuries are reported in the source text. Per the rubric, Class II recalls with no reported hospitalization or injury are typically scored as 2 (Moderate).

Plain-English summary

Lannett Company, Inc. is recalling Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), in 30 mL bottles with dropper, NDC 0527-1768-36. The recall affects approximately 23,598 bottles that were distributed nationwide in the USA.

The recall was initiated because testing identified out-of-specification results for related substances, indicating that the product failed impurities and degradation specifications.

Affected lots are: Lot #2664A, Lot #2664B (expiration date 07/2022), and Lot #2874A, Lot #2874B (expiration date 01/2023).

Patients taking this medication should consult their healthcare provider or pharmacist about the recall. Individuals with questions may contact Lannett Company, Inc.

The recalled product

Product
Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1768-36.
Manufacturer
Lannett Company, Inc.
Category
Drug — Prescription / Quality Defect
Hazard
Affected units
23,598

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 (6)

  • Lot #: 2664A
  • 2664B
  • Exp. date 07/2022
  • 2874A
  • 2874B
  • Exp. date 01/2023

Distribution

Distributed nationwide across the United States.

Related recalls

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