FDA Drug recall D-0825-2020
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…
- FDA Drug
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of 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… by Spectrum Laboratory Products, citing CGMP Deviations: Presence of NDMA impurity detected in product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0825-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-14 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Spectrum Laboratory Products |
| Distribution | AZ, CA, FL, GA, NJ, PA, RI, SC, TX, UT, WY |
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
CGMP Deviations: Presence of NDMA impurity detected in product.
Identifiers
| code_info | Lot #:11E0585, Exp. October 2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0825-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.