Cetirizine Hydrochloride Chewable Tablets — Class III drug recall D-1296-2014
Terminated recall by Caraco Pharmaceutical Laboratories, Ltd., reported 2014-05-07, distributed nationwide. Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing
| Recall number | D-1296-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI, United States |
| Recall initiated | 2014-04-09 |
| Classified | 2014-05-01 |
| Reported by FDA | 2014-05-07 |
| Terminated | 2014-10-07 |
| Distributed | Nationwide (US) |
| Quantity | 128,363 bottles |
| Reason classes | specification failure |
| NDC | 47335-0343-83 |
Product
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
Reason for recall
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
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-1296-2014. 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.