CLASS II Drug recall · Reported 8 Mar 2023 · FDA Enforcement Report
Montelukast Sodium Tablets, USP, 10 mg* recalled by Accord Healthcare
Accord Healthcare is recalling Montelukast Sodium Tablets, USP, 10 mg*, distributed in Puerto Rico. The recall was initiated on 7 Feb 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-0400-2023
- FDA event ID
- 91657
- Recalling firm
- Accord Healthcare, Durham, NC
- Brand
- Montelukast Sodium
- Manufacturer
- Accord Healthcare Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Feb 2023
- FDA classified
- 2 Mar 2023
- Reported
- 8 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Inhalers & Asthma Medication
Timeline
| 7 Feb 2023 | Recall initiated by company | |
| 2 Mar 2023 | Classified by FDA | +23 days |
| 8 Mar 2023 | Published in enforcement report | +6 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: recalling drug products following an FDA inspection.
Product as listed by the FDA
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
Where it was distributed
United States including Puerto Rico and Canada
Questions about this recall
Why was it recalled?
CGMP Deviations: recalling drug products following an FDA inspection.
Which lots are affected?
Batches: a) R2000831, Exp. Date 11/30/2023; R2000832, Exp. Date 11/30/2023; R2200661, Exp. Date 5/31/2025; b)R2000836, R2000837, R2000838, R2000840, R2000842, R2000835, R2000841, R2000833, Exp. Date 11/30/2023; R2100310, R2100311, R2100314, R2100312, R2100313, R2100315, R2100316, R2100317, R2100318, Exp. Date 2/29/2024; R2100859, Exp. Date 5/31/2024; R2100940, R2100993, Exp. Date 7/31/2024; c) R2000473, Exp. Date 8/31/2023; R2000517, Exp. Date 9/30/2023; R2100036, R2100005, R2100037, R2100002, R2100040, R2100044, R2100045, R2100039, R2100038, R2100104, R2100047, R2100048, R2100046, R2100049, R2100056, R2100057, R2100101, R2100058, R2100050, R2100103, R2100102, R2100116, R2100108, R2100105, R2100123, R2100117, R2100118, R2100121, R2100122, R2100128, R2100119, R2100124, Exp. Date 12/31/2023; R2100124, R2100182, R2100184, R2100183, R2100188, R2100189, R2100186, R2100222, R2100197, R2100198, R2100203, R2100192, R2100196, R2100202, R2100199, R2100200, R2100223, R2100224, R2100225, R2100226, R2100228, R2100245, R2100227, R2100230, R2100229, Exp. Date 1/31/2024; R2100246, R2100253, R2100249, R2100251, R2100248, R2100263, R2100254, R2100264, R2100265, R2100266, R2100255, R2100256, R2100257,Exp. Date 2/29/2024; R2100445, R2100446, R2100449, R2100450, R2100451, Exp. Date 3/31/2024; R2100544, R2100545, R2100549, R2100550, R2100567, R2100568, R2100574, R2100576, R2100577, Exp. Date 4/30/2024; R2100594, R2100610, R2100600, R2100624, R2100626, R2100662, R2100661, R2100629, R2100776, R2100693, R2100681, R2100684, Exp. Date 5/31/2024; R2100725, R2100724, R2100726, R2100816, R2100804, R2100815, R2100834, R2100841, Exp. Date 6/30/2024; R2200188, R2200196, R2200195, Exp. Date 1/31/2025; R2200368, R2200366, R2200503, Exp. Date 3/31/2025; R2200659, R2200660, R2200751, R2200759, R2200761, R2200763, Exp. Date 5/31/2025; R2201016, R2201014, Exp. Date 7/31/2025;
Where was it sold?
United States including Puerto Rico and Canada
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
66 other products · FDA event 91657This product is part of a recall event; the main page for the event is Dofetilide Capsules 250 mcg (0.25 mg) recalled by Accord Healthcare.
More recalls from Accord Healthcare
All 106| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium | Accord Healthcare | 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 III | Montelukast Sodium Chewable Tablets, 5 mg recalledMontelukast Sodium | Macleods Pharma Usa | Potency & Assay | Nationwide |