Leader — Class III drug recall D-0386-2022
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2022-01-26, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0386-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2022-01-04 |
| Classified | 2022-01-18 |
| Reported by FDA | 2022-01-26 |
| Terminated | 2023-10-20 |
| Distributed | Nationwide (US) |
| Quantity | 10,536 boxes |
| Reason classes | specification failure |
| NDC | 70000-0518-01 |
| Lot numbers | 79C002625B, AC2103328G, AC2106452C |
| Expiration dates | 2022-04-30, 2023-01-31, 2023-03-31 |
Product
Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardinal Health, Dublin, Ohio 43077, Made in India.
Reason for recall
Failed Dissolution Specifications
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-0386-2022. 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.