FDA drug recalls · openFDA

Is MONTELUKAST SODIUM recalled?

The FDA has recorded 2 recalls of MONTELUKAST SODIUM (2023) , recalled under brand like MONTELUKAST SODIUM.

Class I (most serious)

Class II

Class III

ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of MONTELUKAST SODIUM ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

CGMP Deviations: recalling drug products following an FDA inspection. 1

Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b Class II Terminated

Accord Healthcare, Inc. 2023-02-07 lots: Batches: a) R2000831, Exp. Date 11/30/2023; R2000832, Exp. Date 11/30/2023; R2200661, Exp. Date 5/31/2025; b)R2000836, R2000837, R2000838, R2000840, R2000842, R2000835, R2000841, R2000833, Exp. Date 11/30/2023; R2100310, R2100311, R2100314, R2100312, R2100313, R2100315, R2100316, R2100317, R2100318, Exp. Date 2/29/2024; R2100859, Exp. Date 5/31/2024; R2100940, R2100993, Exp. Date 7/31/2024; c) R2000473, Exp. Date 8/31/2023; R2000517, Exp. Date 9/30/2023; R2100036, R2100005, R2100037, R2100002, R2100040, R2100044, R2100045, R2100039, R2100038, R2100104, R2100047, R2100048, R2100046, R2100049, R2100056, R2100057, R2100101, R2100058, R2100050, R2100103, R2100102, R2100116, R2100108, R2100105, R2100123, R2100117, R2100118, R2100121, R2100122, R2100128, R2100119, R2100124, Exp. Date 12/31/2023; R2100124, R2100182, R2100184, R2100183, R2100188, R2100189, R2100186, R2100222, R2100197, R2100198, R2100203, R2100192, R2100196, R2100202, R2100199, R2100200, R2100223, R2100224, R2100225, R2100226, R2100228, R2100245, R2100227, R2100230, R2100229, Exp. Date 1/31/2024; R2100246, R2100253, R2100249, R2100251, R2100248, R2100263, R2100254, R2100264, R2100265, R2100266, R2100255, R2100256, R2100257,Exp. Date 2/29/2024; R2100445, R2100446, R2100449, R2100450, R2100451, Exp. Date 3/31/2024; R2100544, R2100545, R2100549, R2100550, R2100567, R2100568, R2100574, R2100576, R2100577, Exp. Date 4/30/2024; R2100594, R2100610, R2100600, R2100624, R2100626, R2100662, R2100661, R2100629, R2100776, R2100693, R2100681, R2100684, Exp. Date 5/31/2024; R2100725, R2100724, R2100726, R2100816, R2100804, R2100815, R2100834, R2100841, Exp. Date 6/30/2024; R2200188, R2200196, R2200195, Exp. Date 1/31/2025; R2200368, R2200366, R2200503, Exp. Date 3/31/2025; R2200659, R2200660, R2200751, R2200759, R2200761, R2200763, Exp. Date 5/31/2025; R2201016, R2201014, Exp. Date 7/31/2025;

Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, Class II Terminated

Dr. Reddy's Laboratories, Inc. 2023-10-13 lots: Lot # C2305569, Exp. date 03/31/2026

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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