Ranitidine Oral Solution — Class II drug recall D-1004-2020
Terminated recall by Precision Dose Inc., reported 2020-03-18, distributed nationwide. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
| Recall number | D-1004-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Precision Dose Inc., South Beloit, IL, United States |
| Recall initiated | 2019-11-13 |
| Classified | 2020-03-12 |
| Reported by FDA | 2020-03-18 |
| Terminated | 2022-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 224,940 units |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 68094-0204-59, 68094-0204-61, 68094-0204-62 |
| Lot numbers | 1592, 501290, 501326, 501501, 501679 |
| Expiration dates | 2019-11-30, 2020-04-30 |
Product
Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080
Reason for recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
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-1004-2020. 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.