Drug record
What four public record sets show for montelukast. Saved Nov 10, 2026.
| Shortage | Not on the FDA shortage list | Details |
|---|---|---|
| Pharmacy cost | $0.043 each for the lowest-cost generic | Details |
| Medicare Part D, 2024 | $142.0 million | Details |
| FDA recall records | 14 | Details |
Whether the FDA lists this drug as in short supply.
1 product being discontinued. A maker has told the FDA it will stop making these. That is one maker leaving, not a shortage of the drug:
The list changes daily, and it covers the national supply. A pharmacy near you can be out of a drug that is not listed, or have one that is. See today's status.
The national average price retail pharmacies pay to buy it (NADAC).
The lowest-cost generic on file is Montelukast Sod 10 Mg Tablet: pharmacies pay about $0.043 each, or $1.30 for 30.
| Product as surveyed | Type | Pharmacy pays | For 30 | Price since |
|---|---|---|---|---|
| MONTELUKAST SOD 10 MG TABLET | Generic | $0.043 per each | $1.30 | Oct 21, 2026 |
| MONTELUKAST SOD 4 MG GRANULES | Generic | $0.780 per each | $23.39 | Oct 21, 2026 |
| MONTELUKAST SOD 4 MG TAB CHEW | Generic | $0.078 per each | $2.35 | Oct 21, 2026 |
| MONTELUKAST SOD 5 MG TAB CHEW | Generic | $0.072 per each | $2.17 | Oct 21, 2026 |
| SINGULAIR 10 MG TABLET | Brand | $9.23 per each | $276.82 | Oct 21, 2026 |
| SINGULAIR 5 MG TABLET CHEW | Brand | $9.27 per each | $278.22 | Jan 1, 2026 |
This is not your price. NADAC is the national average that retail pharmacies pay to buy the drug, from the Medicaid survey for the week of Nov 11, 2026. What you pay adds the pharmacy's markup and dispensing fee and depends on your insurance or any discount card. "For 30" is shown only for products priced per tablet or capsule. Brand prices here are before any rebates.
Medicare Part D spending by product, from the latest annual file (2024).
In 2024, Medicare Part D plans and their members paid $142.0 million for the 2 products below. That is down 7% from $152.8 million in 2020.
| Product | 2024 spending | People | Per prescription | Per person, year | 2020 spending |
|---|---|---|---|---|---|
| Montelukast Sodium Montelukast Sodium | $136.3 million | 3,177,221 | $10.93 | $42.89 | $152.8 million |
| Singulair Montelukast Sodium | $5.7 million | 2,574 | $516.01 | $2,222.23 | — |
Spending is the gross amount paid at the pharmacy by Part D plans and patients, before manufacturer rebates, which can be large for brand drugs. The same person can use more than one product, so people are not added up across rows. A dash means the file suppresses a small number or has no figure for that year.
Recalls reported to the FDA that name this drug.
The FDA has 14 recall records that name montelukast in the product description (1 Class I · 8 Class II · 5 Class III). 2 are still marked ongoing.
Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.
Reason: 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 USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30
Reason: CGMP deviations.
Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
Reason: Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Reason: cGMP deviations
Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b) 90-count bottle NDC 16729-119-15 UPC 3 16729 11915 3; c) 1,000-count bottle NDC 16729-119-17 UPC 3 16729 11917 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Reason: CGMP Deviations: recalling drug products following an FDA inspection.
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
Reason: Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.
Reason: Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30
Reason: Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Reason: Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-726-30
Reason: Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Montelukast Sodium active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Reason: 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.
A recall covers specific lots from one company, not every bottle of the drug. Records include combination products and compounded versions that name this ingredient. Class I is the most serious: use could cause serious harm. Class II may cause temporary or reversible harm. Class III is unlikely to cause harm. To check a bottle, match the lot number on the label. See the live list. Do not stop a medicine because of a recall without asking your pharmacist.
These are saved records as of Nov 10, 2026; the sources update daily to yearly. For current figures open the live report for montelukast. This page is public-record information, not medical advice.