FDA Drug recall D-0857-2017
Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind
- FDA Drug
- Class III
- terminated
- Published 2017-05-31
On 2017-05-31 the FDA classified a Class III recall of Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind by Sun Pharmaceutical Industries, citing failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0857-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-04-18 |
| Published | 2017-05-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83.
Reason
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Identifiers
| code_info | Lot #: JKR5135A, Exp 11/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0857-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.