Zantac 75 mg — Class II drug recall D-0545-2020
Ongoing recall by Sanofi-Aventis U.S. LLC, reported 2019-12-11, distributed nationwide. CGMP Deviations: Presence of NDMA impurity detected in product.
| Recall number | D-0545-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sanofi-Aventis U.S. LLC, Bridgewater, NJ, United States |
| Recall initiated | 2019-10-22 |
| Classified | 2019-12-01 |
| Reported by FDA | 2019-12-11 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 00597-0122-01, 00597-0122-08, 00597-0122-13, 00597-0122-37, 00597-0122-40, 00597-0122-54, 00597-0122-61, 00597-0122-81, 00597-0122-96 |
Product
Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 0597-0122-08 0597-0122-13 0597-0122-37 0597-0122-40 0597-0122-54 0597-0122-61 0597-0122-81 0597-0122-96
Reason for recall
CGMP Deviations: Presence of NDMA impurity detected in product.
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-0545-2020. 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.