Nortriptyline HCl Capsules — Class II drug recall D-0246-2021
Terminated recall by Taro Pharmaceuticals U.S.A., Inc., reported 2021-02-10, distributed nationwide. CGMP deviations.
| Recall number | D-0246-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, United States |
| Recall initiated | 2021-01-08 |
| Classified | 2021-02-01 |
| Reported by FDA | 2021-02-10 |
| Terminated | 2023-09-07 |
| Distributed | Nationwide (US) |
| Quantity | 44,256 bottles |
| Reason classes | cgmp |
| NDC | 51672-4001, 51672-4001-01, 51672-4001-02, 51672-4001-05, 51672-4001-06, 51672-4002, 51672-4002-01, 51672-4002-02, 51672-4002-04, 51672-4002-05, 51672-4002-06, 51672-4003, 51672-4003-01, 51672-4003-02, 51672-4003-05, 51672-4003-06, 51672-4004, 51672-4004-01, 51672-4004-02, 51672-4004-05, 51672-4004-06 |
| Expiration dates | 2022-10-31 |
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 for recall
CGMP deviations.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0246-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.