Ranitidine Tablets — Class II drug recall D-0617-2020
Terminated recall by Preferred Pharmaceuticals, Inc, reported 2019-12-18, distributed in CA, FL. CGMP Deviations: Presence of NDMA impurity detected in product.
| Recall number | D-0617-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Preferred Pharmaceuticals, Inc, Anaheim, CA, United States |
| Recall initiated | 2019-12-02 |
| Classified | 2019-12-09 |
| Reported by FDA | 2019-12-18 |
| Terminated | 2023-05-09 |
| Distributed | CA, FL |
| Quantity | 316 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 68788-7078-03, 68788-7078-06 |
| Lot numbers | 12/20, I2519H, I2719O, J1419O, J2819L |
Product
Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
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-0617-2020. 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.