CLASS III Drug recall · Reported 5 Feb 2020 · FDA Enforcement Report
Montelukast Sodium Chewable Tablets, 5 mg recalled
Macleods Pharma Usa is recalling Montelukast Sodium Chewable Tablets, 5 mg, distributed nationwide in the US. The recall was initiated on 20 Jan 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0823-2020
- FDA event ID
- 84749
- Recalling firm
- Macleods Pharma Usa, Plainsboro, NJ
- Brand
- Montelukast Sodium
- Manufacturer
- Macleods Pharmaceuticals Limited
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Jan 2020
- FDA classified
- 31 Jan 2020
- Reported
- 5 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Inhalers & Asthma Medication
Timeline
| 20 Jan 2020 | Recall initiated by company | |
| 31 Jan 2020 | Classified by FDA | +11 days |
| 5 Feb 2020 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Which lots are affected?
Lot #: BMD8901B, Exp. Date 02/2021
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Macleods Pharma Usa
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets USP 150 mcg recalled by Macleods Pharma UsaLevothyroxine Sodium | Macleods Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma USA | Foreign Material | Nationwide |
| Drug | CLASS III | Levofloxacin Tablets, USP 500 mg recalled by Macleods Pharma Usa | Macleods Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Eszopiclone Tablets, USP 1 mg recalled by Macleods Pharma UsaEszopiclone | Macleods Pharma Usa | Packaging Defects | Nationwide |
| Drug | CLASS II | Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma Usa | Potency & Assay | Nationwide |
Other Montelukast recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Montelukast Sodium Tablets, USP 10 mg recalledMontelukast Sodium | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | Montelukast Sodium USP, 10 mg-bottles recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Montelukast Sodium Tablets, USP, 10 mg recalled | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Montelukast Sodium Tablets recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Montelukast Sodium Tablets, USP, 10 mg* recalled by Accord HealthcareMontelukast Sodium | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |