Children's Cetirizine Hydrochloride Chewable Tablets — Class III drug recall D-0857-2017
Terminated recall by Sun Pharmaceutical Industries, Inc., reported 2017-05-31, distributed nationwide. Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
| Recall number | D-0857-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharmaceutical Industries, Inc., Cranbury, NJ, United States |
| Recall initiated | 2017-04-18 |
| Classified | 2017-05-23 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2018-05-18 |
| Distributed | Nationwide (US) |
| Quantity | 13,200 bottles |
| Reason classes | specification failure |
| NDC | 47335-0343-83 |
| Lot numbers | 11/17, JKR5135A |
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 for recall
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
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-0857-2017. 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.