Children's Cetirizine HCl Chewable Tablets 5 mg — Class III drug recall D-008-2013
Terminated recall by Sandoz Incorporated, reported 2012-10-24, distributed nationwide. Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin este
| Recall number | D-008-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Incorporated, Broomfield, CO, United States |
| Recall initiated | 2012-09-20 |
| Classified | 2012-10-18 |
| Reported by FDA | 2012-10-24 |
| Terminated | 2013-01-14 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00781-5283, 00781-5283-06, 00781-5283-64, 00904-5878-33 |
| Lot numbers | BT2862, BT7986, BT7994, BW0652, BW0665, CA3437, CC1961 |
Product
Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33
Reason for recall
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
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-008-2013. 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.