FDA Drug recall D-0616-2020
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02
- FDA Drug
- Class II
- ongoing
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02 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-0616-2020 |
| 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 300 mg, 250-count bottles, NDC 53746-254-02.
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 | HB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020…HB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020 HF13818A 6/2020 HK02818A 9/2020 HK02918A 9/2020 HK03018A 9/2020 HK03118A 9/2020 HL08418A 11/2020 HL08518A 11/2020 HL08618A 11/2020 HL08718A 11/2020 HB01419A 1/2021 HB05619A 1/2021 HB05719A 1/2021 HB05819A 1/2021 HB05919A 1/2021 HB06019A 1/2021 HB06119A 1/2021 |
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-0616-2020%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.