Fexofenadine Hydrochloride Tablets — Class III drug recall D-0654-2026
Ongoing recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2026-07-08, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0654-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2026-06-01 |
| Classified | 2026-06-30 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 9,048 bottles |
| Reason classes | specification failure |
| NDC | 66336-0561-30 |
| Lot numbers | DNF0922A, DNF0923B, DNG0283A |
| Expiration dates | 2026-10-31, 2027-03-31 |
Product
Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30
Reason for recall
Failed Impurities/Degradation 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-0654-2026. 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.