Equate Maximum Strength Ranitidine Tablets — Class II drug recall D-0318-2020
Completed recall by Apotex Inc., reported 2019-11-20, distributed nationwide. GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
| Recall number | D-0318-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Inc., North York, N/A, Canada |
| Recall initiated | 2019-09-24 |
| Classified | 2019-11-12 |
| Reported by FDA | 2019-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 162,344 bottles |
| Reason classes | chemical contamination, specification failure |
| NDC | 49035-0117-06 |
Product
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed By: Wal-Mart Stores, Inc. Bentonville, AR 72716
Reason for recall
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
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-0318-2020. 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.