Class II · Moderate risk
Montelukast Sodium Tablets
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Is Montelukast recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Montelukast (14 total). Check the affected lots below.
Most common reason: cGMP deviation (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Montelukast. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Montelukast recalls on record
none so far in 2026; 14 on record, newest first
Class II · Moderate risk
Montelukast Sodium USP
CGMP deviations.
Class III · Low risk
Montelukast Sodium Oral Granules USP
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Class II · Moderate risk
Montelukast Sodium Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Montelukast Sodium Tablets
cGMP deviations
Class II · Moderate risk
Montelukast Sodium Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class III · Low risk
Montelukast Sodium Chewable Tablets
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Class II · Moderate risk
Montelukast Sodium Tablets
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Class I · High risk
Montelukast Sodium Tablets 10 mg
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Class III · Low risk
Montelukast Sodium Oral Granules
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Class III · Low risk
Montelukast sodium tablets
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Class II · Moderate risk
Montelukast Sodium active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Montelukast Sodium
Labeling: Label Mixup: MONTELUKAST SODIUM, CHEW Tablet, 4 mg may be potentially mislabeled as the following drug: DICYCLOMINE HCL, Tablet, 20 mg, NDC 00591079501, Pedigree: AD76639_4, EXP: 5/31/2014.
Class III · Low risk
Montelukast Sodium Tablets
Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).
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