CLASS III Drug recall · Reported 13 Mar 2013 · FDA Enforcement Report
Montelukast Sodium Tablets, 10 mg (base) recalled
Glenmark Generics Inc. USA is recalling Montelukast Sodium Tablets, 10 mg (base), distributed nationwide in the US. The recall was initiated on 13 Feb 2013 and the FDA has classified it as Class III.
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-182-2013
- FDA event ID
- 64338
- Recalling firm
- Glenmark Generics Inc. USA, Mahwah, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Feb 2013
- FDA classified
- 5 Mar 2013
- Reported
- 13 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Inhalers & Asthma Medication
Timeline
| 13 Feb 2013 | Recall initiated by company | |
| 5 Mar 2013 | Classified by FDA | +20 days |
| 13 Mar 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count tablets per bottle (NDC 68462-392-90), Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).
Which lots are affected?
02122956, 02123226, 02123269, 02123480, 02123481, 02122933, 02122955, 02123062, 02123075, 02123085, 02123114, 02123115, 02123124, 02123125, 02123189, 02123199, 02123205, 02123219, 02123253, 02123270, 02123289, 02123295, 02123320, 02123333, 02123343, 02123349, 02123411, 02123421, 02123431, Exp 09/14 and 10/14
Where was it sold?
Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Glenmark Generics Inc. USA
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ranitidine Tablets USP, 150 mg recalled by Glenmark Generics Inc., U | Glenmark Generics Inc. USA | Foreign Material | Nationwide |
| Drug | CLASS III | Glenmark Topiramate Tablets, 200 mg recalledTopiramate | Glenmark Generics Inc. USA | Other | Nationwide |
| Drug | CLASS III | Glenmark Pravastatin Sodium Tablets ,40 mg bottle recalledPravastatin Sodium | Glenmark Generics Inc. USA | Other | Nationwide |
| Drug | CLASS III | Glenmark Gabapentin Tablets, a) 600mg bottle recalledGabapentin | Glenmark Generics Inc. USA | Other | Nationwide |
| Drug | CLASS II | Naproxen Tablets recalled by Glenmark Generics Inc., UNaproxen Sodium | Glenmark Generics Inc. USA | Packaging Defects | 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 II | Montelukast Sodium Tablets, USP, 10 mg* recalled by Accord HealthcareMontelukast Sodium | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |