ranitidine hydrochloride — Class II drug recall D-0826-2020
Terminated recall by PD-Rx Pharmaceuticals, Inc., reported 2020-02-12, distributed in AZ, CA, FL, IL, IN, KY, ME, MS…. CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above establi
| Recall number | D-0826-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK, United States |
| Recall initiated | 2020-01-10 |
| Classified | 2020-02-04 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2021-03-23 |
| Distributed | AZ, CA, FL, IL, IN, KY, ME, MS, OK, OR, PA, TN |
| Reason classes | chemical contamination, cgmp |
| NDC | 43063-0844-01, 43063-0844-14, 43063-0844-30, 43063-0844-60, 43063-0844-90 |
| Expiration dates | 2020-05-31, 2020-11-30 |
Product
ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
Reason for recall
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
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-0826-2020. 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.