Fexofenadine HCl — Class III drug recall D-0275-2022
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2021-12-15, distributed nationwide. Failed dissolution specifications
| Recall number | D-0275-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2021-11-12 |
| Classified | 2021-12-07 |
| Reported by FDA | 2021-12-15 |
| Terminated | 2023-06-23 |
| Distributed | Nationwide (US) |
| Quantity | 2,928 cartons |
| Reason classes | specification failure |
| NDC | 43598-0823, 43598-0823-14, 43598-0823-31, 43598-0823-35 |
| Lot numbers | AC2103329A |
Product
Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ, 08640, Made in India NDC Walmart Inc., Bentonville, AR 72716, Product of India, NDC 43598-823-31.
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-0275-2022. 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.