CLASS II Drug recall · Reported 5 Apr 2023 · FDA Enforcement Report
Montelukast Sodium Tablets recalled by Direct Rx
Direct Rx is recalling Montelukast Sodium Tablets, USP, distributed nationwide in the US. The recall was initiated on 13 Mar 2023 and the FDA has classified it as Class II.
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-0476-2023
- FDA event ID
- 91921
- Recalling firm
- Direct Rx, Dawsonville, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Mar 2023
- FDA classified
- 24 Mar 2023
- Reported
- 5 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Inhalers & Asthma Medication
Timeline
| 13 Mar 2023 | Recall initiated by company | |
| 24 Mar 2023 | Classified by FDA | +11 days |
| 5 Apr 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
cGMP deviations
Which lots are affected?
a) [30 count bottles] Lot, expiry: 20JU2211, exp 5/31/2024; b) [90 count bottles] Lot, expiry: 25JU2128 , exp 12/31/2023; 13SE2132 , exp 12/31/2023; 25JU2133 , exp 12/31/2023; 16JU2127 , exp 12/31/2023; 18MY2126 , exp 12/31/2023; 10JU2111 , exp 12/31/2023; 14SE2111 , exp 1/31/2024 ; 14JY2115 , exp 1/31/2024 ; 25OC2113 , exp 2/29/2024 ; 21SE2227 , exp 2/29/2024 ; 10DE2123 , exp 3/31/2024 ; 22NO2115 , exp 3/31/2024 ; 21JA2202 , exp 4/30/2024 ; 29DE2110 , exp 4/30/2024 ; 28FE2227 , exp 4/30/2024 ; 06JU2208 , exp 5/31/2024 ; 30MA2229 , exp 5/31/2024 ; 30AU2216 , exp 6/30/2024 ; 23NO2203 , exp 6/30/2024 ; 14DE2216 , exp 7/31/2025 ; 12JA2305 , exp 7/31/2025 .
Where was it sold?
Nationwide in the USA
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
10 other products · FDA event 91921This product is part of a recall event; the main page for the event is Glimepiride recalled by Direct Rx.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Glimepiride recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Simvastatin recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Simvastatin, USP, 40 mg recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Ropinirole recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Glimepiride recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Glimepiride recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Ropinirole recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Simvastatin recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Finasteride recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Simvastatin recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Direct Rx
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Duloxetine D/R, a) 30 mg recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine D/R, 30 mg, 30 Caps recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine D/R, 20 mg, 30 Caps recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophth Solution recalled by Direct Rx | Direct Rx | Packaging Defects | 5 states |
| Drug | CLASS II | Ibuprofen 800mg, Generic for: Motrin, Each tablet contains recalled | Direct Rx | 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, USP, 10 mg* recalled by Accord HealthcareMontelukast Sodium | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS III | Montelukast Sodium Chewable Tablets, 5 mg recalledMontelukast Sodium | Macleods Pharma Usa | Potency & Assay | Nationwide |