The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0476-2023·Announced 2023-04-05

Drug Recall: Montelukast Sodium Tablets Due to Manufacturing Deviations

Direct Rx is recalling Montelukast Sodium 10 mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects approximately 508 bottles distributed across the United States.

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 initiated by the manufacturer for manufacturing process deviations, with no specific identified product defect. The voluntary nature of the recall supports a Moderate severity rating.

Plain-English summary

Direct Rx is recalling Montelukast Sodium Tablets, USP, 10 mg distributed nationwide in the United States. The recall affects 30-count bottles (NDC 61919-0009-30) and 90-count bottles (NDC 61919-0009-90) packaged and distributed by Direct Rx in Dawsonville, Georgia. Multiple lot codes are affected with expiration dates ranging from December 2023 through July 2025.

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing. This is a voluntary, firm-initiated recall classified as FDA Class II.

Approximately 13 units of the 30-count bottles and 495 units of the 90-count bottles were distributed. Patients using this medication should consult their healthcare provider or pharmacist regarding their current supply and whether any action is needed.

The recall was terminated on June 17, 2024.

The recalled product

Product
Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Manufacturer
Direct Rx
Category
Drug
Hazard

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 (20)

  • a) [30 count bottles] Lot
  • expiry: 20JU2211
  • exp 5/31/2024
  • b) [90 count bottles] Lot
  • expiry: 25JU2128
  • exp 12/31/2023
  • 13SE2132
  • 25JU2133
  • 16JU2127
  • 18MY2126
  • 10JU2111
  • 14SE2111
  • exp 1/31/2024
  • 14JY2115
  • 25OC2113
  • exp 2/29/2024
  • 21SE2227
  • 10DE2123
  • exp 3/31/2024
  • 22NO2115

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Direct Rx 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 11 products in this recall →

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