FDA Drug recall D-1213-2018
Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Naga…
- FDA Drug
- Class II
- terminated
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class II recall of Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Naga… by Hetero Labs Unit V, citing discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1213-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-20 |
| 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 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
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
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 #: MON17355, Exp 12/19 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1213-2018%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.