FDA Drug recall D-0081-2019
Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -…
- FDA Drug
- Class I
- ongoing
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class I recall of Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -… by Hetero Labs Unit V, citing labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0081-2019 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2018-08-15 |
| Published | 2018-10-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hetero Labs Unit V |
| Distribution | US |
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
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Identifiers
| ndc | 31722-726-30 |
|---|---|
| ndc | 31722-726-90 |
| ndc | 31722-726-01 |
| ndc | 31722-726-10 |
| ndc | 31722-726-31 |
| ndc | 31722-726-32 |
| code_info | Lot #: MON17384, Exp 12/19 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0081-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.