Amitriptyline HCl Tablets — Class III drug recall D-0943-2017
Terminated recall by Sandoz Incorporated, reported 2017-07-12, distributed nationwide. Cross Contamination With Other Product: Imipramine
| Recall number | D-0943-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Incorporated, Broomfield, CO, United States |
| Recall initiated | 2017-06-16 |
| Classified | 2017-07-06 |
| Reported by FDA | 2017-07-12 |
| Terminated | 2019-01-14 |
| Distributed | Nationwide (US) |
| Quantity | 38,234 bottles |
| NDC | 00781-1486, 00781-1486-01, 00781-1486-10, 00781-1486-31, 00781-1487, 00781-1487-01, 00781-1487-10, 00781-1487-31, 00781-1488, 00781-1488-01, 00781-1488-10, 00781-1488-31, 00781-1489, 00781-1489-01, 00781-1489-10, 00781-1489-31, 00781-1490, 00781-1490-01, 00781-1490-10, 00781-1490-31, 00781-1491, 00781-1491-01, 00781-1491-10, 00781-1491-31 |
| Expiration dates | 2019-08 |
Product
Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540
Reason for recall
Cross Contamination With Other Product: Imipramine
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-0943-2017. 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.