Rugby — Class III drug recall D-0379-2022
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2022-01-26, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0379-2022 |
|---|---|
| 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 | 2,352 boxes |
| Reason classes | specification failure |
| NDC | 00536-1242-07 |
| Lot numbers | AC2106452F |
| Expiration dates | 2023-03-31 |
Product
Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, 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-0379-2022. 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.