Macleods Pharma USA recalls 5mg Montelukast chewable tablets due to failed dissolution testing in one batch. Affected products have NDC 33342-111-10 and Lot BMD8901B. No specific remedy provided in recall notice.
Macleods Pharma USA is recalling 5mg Montel: 90-count chewable tablets that failed dissolution testing in one manufacturing batch. This could mean the medication doesn't work properly for some users, though the recall doesn't specify how many people are affected or what to do. Read more at govinfonow.com/recall/37405-macleods-montelukast-tablets-recall-failed-dissolution-testing-risk.
“Macleods Montelukast Tablets Recall: Failed Dissolution Testing Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37405-macleods-montelukast-tablets-recall-failed-dissolution-testing-risk. Based on FDA recall #D-0823-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0823-2020%22&limit=1).
The FDA announced on Jan. 20, 2020, that Macleods Pharma USA Inc voluntarily recalled Montelukast Sodium Chewable Tablets due to failed dissolution specifications. The agency issued recall number D-0823-2020 for the affected product.
Testing revealed low out-of-specification results in one lot of the product. The recall is classified as Class III.
Context
GovInfoNow's records show Macleods Pharma USA, Inc has 20 other recalls on record since Dec. 24, 2015. Other recent recalls include a Feb. 26, 2026 Levothyroxine Tablets recall for subpotent drug risk and a May 7, 2024 Losartan/HCTZ recall for foreign substance hazards. Similar product recalls involving failed dissolution specifications include Teva Metoprolol Succinate Tablets on Jan. 29, 2026, Sun Pharmaceutical Lisdexamfetamine Capsules on Oct. 28, 2025, and Lannett Niacin Extended-release Tablets on May 27, 2026.
How to tell if you have this one
Check for NDC code 33342-111-10 and lot number BMD8901B on the bottle. The product was manufactured in Plainsboro, NJ and expires February 2021.
Brand
Macleods
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for NDC 33342-111-10 and lot number BMD8901B on the bottle label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0823-2020 (January 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0823-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.