12 HR Allergy & Congestion Relief Fexofenadine HCl — Class III drug recall D-0272-2022
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2021-12-15, distributed nationwide. Failed dissolution specifications
| Recall number | D-0272-2022 |
|---|---|
| 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 | 2,496 cartons |
| Reason classes | specification failure |
| NDC | 70000-0518-01 |
| Lot numbers | AC2103329G |
| Expiration dates | 2023-01 |
Product
12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1.
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-0272-2022. 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.