Cetirizine HCl Chewable Tablet — Class III drug recall D-1115-2015
Terminated recall by Sandoz, Inc, reported 2015-06-10, distributed nationwide. Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity a
| Recall number | D-1115-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz, Inc, Princeton, NJ, United States |
| Recall initiated | 2015-04-15 |
| Classified | 2015-06-03 |
| Reported by FDA | 2015-06-10 |
| Terminated | 2016-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 1,023,430 units |
| Reason classes | specification failure |
| NDC | 66394-0041-06 |
| Lot numbers | DP3841, DP5237, DP5238, DP5238A, DP5238B, DR7807, DR9954, DR9959, DV5838 |
| Expiration dates | 2015-05, 2015-07 |
Product
Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College Road West, Princeton, NJ 08540. NDC 66394-041-06
Reason for recall
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
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-1115-2015. 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.