Antihistamine & Nasal Decongestant — Class III drug recall D-0270-2022
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2021-12-15, distributed nationwide. Failed dissolution specifications
| Recall number | D-0270-2022 |
|---|---|
| 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 | 2,352 cartons |
| Reason classes | specification failure |
| NDC | 00536-1242-34 |
| Lot numbers | AC2103329H |
| Expiration dates | 2023-01 |
Product
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0536-1242-34.
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-0270-2022. 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.