FDA Drug recall D-0273-2024
Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30
- FDA Drug
- Class II
- completed
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class II recall of Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30 by Sun Pharmaceutical Industries, citing CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0273-2024 |
| Classification | Class II |
| Status | completed |
| Initiated | 2024-01-18 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India.
Reason
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Identifiers
| ndc | 51660-998-30 |
|---|---|
| ndc | 51660-998-55 |
| ndc | 51316-800-90 |
| ndc | 51316-800-70 |
| ndc | 51316-800-45 |
| ndc | 51316-800-30 |
| ndc | 51316-800-15 |
| ndc | 51316-800-08 |
| code_info | Lot #s: a) DNE0792A Exp. 06/31/2025; DNE1027A Exp. 08/31/2025. b) DNE0793A Exp. 06/31/2025. c) DNE0789A, DNE0790A, DNE…Lot #s: a) DNE0792A Exp. 06/31/2025; DNE1027A Exp. 08/31/2025. b) DNE0793A Exp. 06/31/2025. c) DNE0789A, DNE0790A, DNE0791A Exp. 06/2025, DNE1026A Exp. 08/31/025. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0273-2024%22
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