FDA Drug recall D-0615-2020
Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10
- FDA Drug
- Class II
- ongoing
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10 by Amneal Pharmaceuticals, citing CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0615-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-11-22 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | US |
Product
Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.
Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Identifiers
| ndc | 53746-253-60 |
|---|---|
| ndc | 53746-253-01 |
| ndc | 53746-253-18 |
| ndc | 53746-253-05 |
| ndc | 53746-253-10 |
| ndc | 53746-254-30 |
| ndc | 53746-254-01 |
| ndc | 53746-254-02 |
| code_info | HB03718A 3/2020 HB03818A 3/2020 HB03918A 3/2020 HB04018A 3/2020 HC01618A 3/2020 HC14618A 5/2020 HC14718A 5/2020…HB03718A 3/2020 HB03818A 3/2020 HB03918A 3/2020 HB04018A 3/2020 HC01618A 3/2020 HC14618A 5/2020 HC14718A 5/2020 HC14818A 5/2020 HC14918A 5/2020 HC15018A 5/2020 HK02318A 9/2020 HK02418A 9/2020 HK02518A 9/2020 HK02618A 9/2020 HD03119A 3/2021 HD03219A 3/2021 HE03119A 4/2021 HE03219A 4/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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All Amneal Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0615-2020%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.