FDA Drug recall D-0386-2022
Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Re…
- FDA Drug
- Class III
- terminated
- Published 2022-01-26
On 2022-01-26 the FDA classified a Class III recall of Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Re… by Dr Reddy S Laboratories, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0386-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-01-04 |
| Published | 2022-01-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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
Failed Dissolution Specifications
Identifiers
| code_info | Lot #s: 79C002625B, Exp. 4/30/2022; AC2103328G, Exp. 1/31/2023; AC2106452C, Exp. 3/31/2023. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2025-07-23 · Dr Reddy S Laboratories - Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyd…
FDA Drug · Class I · 2025-04-23 · Dr Reddy S Laboratories - Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ…
FDA Drug · Class III · 2024-12-18 · Dr Reddy S Laboratories
All Dr Reddy S Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0386-2022%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.