Montelukast Sodium Tablets 10 mg — Class I drug recall D-0081-2019
Ongoing recall by Hetero Labs Limited Unit V, reported 2018-10-03, distributed nationwide. Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Lo
| Recall number | D-0081-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hetero Labs Limited Unit V, Jadcherla Mandal, Mahaboob Nagar, India |
| Recall initiated | 2018-08-15 |
| Classified | 2018-10-17 |
| Reported by FDA | 2018-10-03 |
| Distributed | Nationwide (US) |
| Quantity | 98,016 bottles |
| Reason classes | labeling |
| NDC | 31722-0726, 31722-0726-01, 31722-0726-10, 31722-0726-30, 31722-0726-31, 31722-0726-32, 31722-0726-90 |
| Lot numbers | 12/19, MON17384 |
Product
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 for recall
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0081-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.