“Teva Montelukast Sodium Oral Granules 4mg Recall: Failed Impurities Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33750-teva-montelukast-sodium-oral-granules-4mg-recall-failed-impurities-risk. Based on FDA recall #D-0510-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0510-2023%22&limit=1).
The FDA announced on March 27, 2023, that Teva Pharmaceuticals USA Inc. is recalling Montelukast Sodium Oral Granules USP, 4 mg, due to failed impurity specifications. The recall affects 3,772 cartons distributed nationwide.
The product failed impurities for Sulphoxide and Impurity A. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Teva Pharmaceuticals USA, Inc. has 59 other recalls on record since April 2, 2012. Other recent recalls of similar products include Teva recalling traZODone 50mg tablets on August 24, 2026, and Teva Octreotide Acetate 30mg Kit on April 24, 2026. Recent industry recalls also include Sagent Busulfan Injection on May 4, 2026, QuVa Pharma Methohexital Sodium on June 24, 2026, and OneSource Specialty Pharma Methohexital Sodium on June 7, 2026.
How to tell if you have this one
Check for the carton NDC 0093-7487-56 and packet NDC 0093-7487-19. Look for lot number 3007556A with expiration date 5/2023.
Brand
Teva
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the carton NDC 0093-7487-56, packet NDC 0093-7487-19, and lot number 3007556A.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 5 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-0510-2023 (March 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0510-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.