Montelukast Sodium Tablets — Class II drug recall D-0518-2023
Ongoing recall by Preferred Pharmaceuticals, Inc., reported 2023-04-12, distributed nationwide. cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
| Recall number | D-0518-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Preferred Pharmaceuticals, Inc., Anaheim, CA, United States |
| Recall initiated | 2023-03-23 |
| Classified | 2023-04-06 |
| Reported by FDA | 2023-04-12 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 68788-9438-03, 68788-9438-06, 68788-9438-09 |
| Lot numbers | F1021I, F3021D, H1721R, L0722E, L0722T |
| Expiration dates | 2023-12-31, 2025-05-31 |
Product
Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Reason for recall
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
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-0518-2023. 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.