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.
Montelukast Sodium Chewable Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10
Affected NDC
33342-0111-10
Compare with the code on your package — it is the most precise check available.
Drug: Montelukast
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Montelukast sodium NDC 33342-0111 |
MONTELUKAST 5 mg/1 | Tablet, Chewable Oral |
Macleods Pharmaceuticals Limited | Rx |
- Recalling firm
- Macleods Pharma Usa Inc
- NDC code
- 33342-111-10
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0823-2020 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Montelukast recalls
See all
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
Other recalls by Macleods Pharma Usa Inc
All 2020 recalls
Class II · Moderate risk
Levothyroxine Sodium Tablets USP 150 mcg
Subpotent Drug
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
Presence of foreign substance: plastic-like substance.
Class III · Low risk
Levofloxacin Tablets
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Class II · Moderate risk
Eszopiclone Tablets
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
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