Amitriptyline HCL Tablets — Class II drug recall D-1115-2017
Terminated recall by C. O. Truxton, reported 2017-08-30, distributed nationwide. Labeling: Label Mixup; potentially mislabeled
| Recall number | D-1115-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C. O. Truxton, Bellmawr, NJ, United States |
| Recall initiated | 2017-04-20 |
| Classified | 2017-08-22 |
| Reported by FDA | 2017-08-30 |
| Terminated | 2018-09-11 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| NDC | 00463-6352-10 |
| Lot numbers | 03/18, C0260416A |
Product
Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distributed by: Truxton, Inc. Bellmawr, NJ 08031, NDC: 0463-6352-10
Reason for recall
Labeling: Label Mixup; potentially mislabeled
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-1115-2017. 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.