FDA Drug recall D-0476-2023

Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30

FDA Drug
Class II
terminated
Published 2023-04-05

On 2023-04-05 the FDA classified a Class II recall of Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30 by Direct Rx, citing cGMP deviations.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0476-2023
Classification	Class II
Status	terminated
Initiated	2023-03-13
Published	2023-04-05
Last updated	2026-09-13 11:52 UTC
Company	Direct Rx
Distribution	US

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

Reason

cGMP deviations

Identifiers

code_info	a) [30 count bottles] Lot, expiry: 20JU2211, exp 5/31/2024; b) [90 count bottles] Lot, expiry: 25JU2128 , exp 12/31/… a) [30 count bottles] Lot, expiry: 20JU2211, exp 5/31/2024; b) [90 count bottles] Lot, expiry: 25JU2128 , exp 12/31/2023; 13SE2132 , exp 12/31/2023; 25JU2133 , exp 12/31/2023; 16JU2127 , exp 12/31/2023; 18MY2126 , exp 12/31/2023; 10JU2111 , exp 12/31/2023; 14SE2111 , exp 1/31/2024 ; 14JY2115 , exp 1/31/2024 ; 25OC2113 , exp 2/29/2024 ; 21SE2227 , exp 2/29/2024 ; 10DE2123 , exp 3/31/2024 ; 22NO2115 , exp 3/31/2024 ; 21JA2202 , exp 4/30/2024 ; 29DE2110 , exp 4/30/2024 ; 28FE2227 , exp 4/30/2024 ; 06JU2208 , exp 5/31/2024 ; 30MA2229 , exp 5/31/2024 ; 30AU2216 , exp 6/30/2024 ; 23NO2203 , exp 6/30/2024 ; 14DE2216 , exp 7/31/2025 ; 12JA2305 , exp 7/31/2025 .

code_info

a) [30 count bottles] Lot, expiry: 20JU2211, exp 5/31/2024; b) [90 count bottles] Lot, expiry: 25JU2128 , exp 12/31/…

a) [30 count bottles] Lot, expiry: 20JU2211, exp 5/31/2024; b) [90 count bottles] Lot, expiry: 25JU2128 , exp 12/31/2023; 13SE2132 , exp 12/31/2023; 25JU2133 , exp 12/31/2023; 16JU2127 , exp 12/31/2023; 18MY2126 , exp 12/31/2023; 10JU2111 , exp 12/31/2023; 14SE2111 , exp 1/31/2024 ; 14JY2115 , exp 1/31/2024 ; 25OC2113 , exp 2/29/2024 ; 21SE2227 , exp 2/29/2024 ; 10DE2123 , exp 3/31/2024 ; 22NO2115 , exp 3/31/2024 ; 21JA2202 , exp 4/30/2024 ; 29DE2110 , exp 4/30/2024 ; 28FE2227 , exp 4/30/2024 ; 06JU2208 , exp 5/31/2024 ; 30MA2229 , exp 5/31/2024 ; 30AU2216 , exp 6/30/2024 ; 23NO2203 , exp 6/30/2024 ; 14DE2216 , exp 7/31/2025 ; 12JA2305 , exp 7/31/2025 .

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0476-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.