Ranitidine Hydrochloride — Class II drug recall D-0825-2020
Terminated recall by Spectrum Laboratory Products, reported 2020-02-12, distributed in AZ, CA, FL, GA, NJ, PA, RI, SC…. CGMP Deviations: Presence of NDMA impurity detected in product.
| Recall number | D-0825-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectrum Laboratory Products, Gardena, CA, United States |
| Recall initiated | 2020-01-14 |
| Classified | 2020-02-04 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2023-12-05 |
| Distributed | AZ, CA, FL, GA, NJ, PA, RI, SC, TX, UT, WY |
| Countries outside the US | AE, CA |
| Reason classes | chemical contamination, cgmp, specification failure |
| Lot numbers | 11E0585 |
| Expiration dates | 2023-10-20 |
Product
Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram
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-0825-2020. 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.