FDA Drug recall D-0246-2021
Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd
- FDA Drug
- Class II
- terminated
- Published 2021-02-10
On 2021-02-10 the FDA classified a Class II recall of Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd by Taro Pharmaceuticals U, citing CGMP deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0246-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-08 |
| Published | 2021-02-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Taro Pharmaceuticals U |
| Distribution | US |
Product
Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672-4001-1
Reason
CGMP deviations.
Identifiers
| ndc | 51672-4001-6 |
|---|---|
| ndc | 51672-4001-5 |
| ndc | 51672-4001-1 |
| ndc | 51672-4001-2 |
| ndc | 51672-4002-6 |
| ndc | 51672-4002-4 |
| ndc | 51672-4002-5 |
| ndc | 51672-4002-1 |
| ndc | 51672-4002-2 |
| ndc | 51672-4003-6 |
| ndc | 51672-4003-5 |
| ndc | 51672-4003-1 |
| ndc | 51672-4003-2 |
| ndc | 51672-4004-6 |
| ndc | 51672-4004-5 |
| ndc | 51672-4004-1 |
| ndc | 51672-4004-2 |
| code_info | AC05096, AC05098, and AC05099; Exp 10/31/2022 |
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-0246-2021%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.