CLASS I ONGOING Drug recall · Reported 3 Oct 2018 · FDA Enforcement Report
Montelukast Sodium Tablets 10 mg recalled by Hetero Labs Limited Unit V
Hetero Labs Limited Unit V is recalling Montelukast Sodium Tablets 10 mg, distributed nationwide in the US. The recall was initiated on 15 Aug 2018 and the FDA has classified it as Class I.
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-0081-2019
- FDA event ID
- 80803
- Recalling firm
- Hetero Labs Limited Unit V, Jadcherla Mandal, Mahaboob Nagar
- Brand
- Montelukast Sodium
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 15 Aug 2018
- FDA classified
- 17 Oct 2018
- Reported
- 3 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Inhalers & Asthma Medication
Timeline
| 15 Aug 2018 | Recall initiated by company | |
| 3 Oct 2018 | Published in enforcement report | +49 days |
| 17 Oct 2018 | Classified by FDA | +14 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
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, 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
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Which lots are affected?
Lot #: MON17384, Exp 12/19
Where was it sold?
U.S.A. 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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 Hetero Labs Limited Unit V
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg recalledPantoprazole Sodium | Hetero Labs Limited (Unit V) | Other | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets USP, 50 mg recalled | Hetero Labs Limited (Unit V) | Other | Nationwide |
| Drug | CLASS II | Montelukast Sodium Tablets, 10 mg* recalledMontelukast Sodium | Hetero Labs Limited Unit V | Other | Nationwide |
| Drug | CLASS II | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg recalledValsartan | Hetero Labs Limited Unit V | Potency & Assay | Nationwide |
| Drug | CLASS II | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg recalledValsartan | Hetero Labs Limited Unit V | 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 II | Montelukast Sodium Tablets, USP, 10 mg* recalled by Accord HealthcareMontelukast Sodium | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |