FDA Drug recall D-0943-2017
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…
- FDA Drug
- Class III
- terminated
- Published 2017-07-12
On 2017-07-12 the FDA classified a Class III recall of 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… by Sandoz, citing cross Contamination With Other Product: Imipramine.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0943-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-06-16 |
| Published | 2017-07-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sandoz |
| Distribution | US |
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
Cross Contamination With Other Product: Imipramine
Identifiers
| ndc | 0781-1486-10 |
|---|---|
| ndc | 0781-1486-01 |
| ndc | 0781-1486-31 |
| ndc | 0781-1487-10 |
| ndc | 0781-1487-01 |
| ndc | 0781-1487-31 |
| ndc | 0781-1488-10 |
| ndc | 0781-1488-01 |
| ndc | 0781-1488-31 |
| ndc | 0781-1489-31 |
| ndc | 0781-1489-01 |
| ndc | 0781-1489-10 |
| ndc | 0781-1490-10 |
| ndc | 0781-1490-01 |
| ndc | 0781-1490-31 |
| ndc | 0781-1491-10 |
| ndc | 0781-1491-01 |
| ndc | 0781-1491-31 |
| code_info | Lot #: a) GR3831, GS9690, Exp. 08/2019; b) GR3832, Exp. 08/2019. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0943-2017%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.