Montelukast sodium tablets — Class III drug recall D-0623-2017
Terminated recall by Hetero USA Inc, reported 2017-04-05, distributed nationwide. Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a b
| Recall number | D-0623-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hetero USA Inc, Piscataway, NJ, United States |
| Recall initiated | 2017-01-07 |
| Classified | 2017-03-29 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2017-08-08 |
| Distributed | Nationwide (US) |
| Quantity | 65,664 bottles |
| NDC | 31722-0726, 31722-0726-01, 31722-0726-10, 31722-0726-30, 31722-0726-31, 31722-0726-32, 31722-0726-90 |
| Lot numbers | 01/18, MON16001B |
Product
Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-726-30
Reason for recall
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
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-0623-2017. 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.