FDA Drug recall D-0269-2022
Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distributed by: Dr. Reddy…
- FDA Drug
- Class III
- terminated
- Published 2021-12-15
On 2021-12-15 the FDA classified a Class III recall of Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distributed by: Dr. Reddy… by Dr Reddy S Laboratories, citing failed dissolution specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0269-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-11-12 |
| Published | 2021-12-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, NDC 43598-823-14.
Reason
Failed dissolution specifications
Identifiers
| ndc | 43598-823-14 |
|---|---|
| ndc | 43598-823-31 |
| ndc | 43598-823-35 |
| code_info | Lot #: AC2103329F, Exp 1/2023 |
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-0269-2022%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.