Dr — Class III drug recall D-0382-2022
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2022-01-26, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0382-2022 |
|---|---|
| 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 | 9,912 boxes |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00343598823140, 00343598823317, 00343598823355 |
| Expiration dates | 2022-08-31, 2023-01-31, 2023-03-31 |
Product
Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, 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-0382-2022. 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.