Montelukast Sodium Tablets — Class II drug recall D-1213-2018
Terminated recall by Hetero Labs Limited Unit V, reported 2018-10-03, distributed nationwide. Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
| Recall number | D-1213-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hetero Labs Limited Unit V, Jadcherla Mandal, Mahaboob Nagar, India |
| Recall initiated | 2018-08-20 |
| Classified | 2018-09-26 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2021-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 98,016 bottles |
| 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, MON17355 |
Product
Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.
Reason for recall
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
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-1213-2018. 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.