CVS Health — Class III drug recall D-0385-2022
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2022-01-26, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0385-2022 |
|---|---|
| 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 | 41,784 boxes |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00050428290538, 00050428436189 |
| Expiration dates | 2022-04-30, 2022-08-31, 2023-01-31 |
Product
CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI, 02895, 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-0385-2022. 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.