FDA Drug recall D-0134-2020
Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10
- FDA Drug
- Class III
- terminated
- Published 2019-10-16
On 2019-10-16 the FDA classified a Class III recall of Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10 by Amneal Pharmaceuticals, citing presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0134-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-09-24 |
| Published | 2019-10-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | US |
Product
Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10
Reason
Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
Identifiers
| ndc | 65162-751-03 |
|---|---|
| ndc | 65162-751-10 |
| ndc | 65162-751-50 |
| ndc | 65162-752-03 |
| ndc | 65162-752-10 |
| ndc | 65162-752-50 |
| ndc | 65162-753-03 |
| ndc | 65162-753-10 |
| ndc | 65162-753-50 |
| ndc | 65162-754-03 |
| ndc | 65162-754-10 |
| ndc | 65162-754-50 |
| code_info | Lot # BB02619A, exp. date 04/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Amneal Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0134-2020%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.