CLASS II Drug recall · Reported 30 Aug 2017 · FDA Enforcement Report
Amitriptyline HCL Tablets, USP 50 mg recalled by C. O. Truxton
C. O. Truxton is recalling Amitriptyline HCL Tablets, USP 50 mg, distributed nationwide in the US. The recall was initiated on 20 Apr 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1115-2017
- FDA event ID
- 77082
- Recalling firm
- C. O. Truxton, Bellmawr, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Apr 2017
- FDA classified
- 22 Aug 2017
- Reported
- 30 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
- Drug class
- Antidepressants
Timeline
| 20 Apr 2017 | Recall initiated by company | |
| 22 Aug 2017 | Classified by FDA | +124 days |
| 30 Aug 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mixup; potentially mislabeled
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Is Amitriptyline HCL Tablets, USP 50 mg recalled?
Yes. C. O. Truxton recalled Amitriptyline HCL Tablets, USP 50 mg on 20 Apr 2017. The recall is Class II and its status is Terminated. Recall number D-1115-2017.
Why was it recalled?
Labeling: Label Mixup; potentially mislabeled
Which lots are affected?
Lot # C0260416A; Exp. 03/18
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from C. O. Truxton
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenobarbital Tablets USP, 100 mg, a) bottles recalled by C. O. Truxton | C. O. Truxton | Labeling Errors | Nationwide |
| Drug | CLASS II | Phenobarbital Tablets USP, 60 mg recalled by C. O. Truxton | C. O. Truxton | Labeling Errors | Nationwide |
| Drug | CLASS II | Phenobarbital Tablets USP, 15 mg recalled by C. O. Truxton | C. O. Truxton | Labeling Errors | Nationwide |
| Drug | CLASS I | Phenobarbital Tablets USP, 15 mg recalled by C. O. Truxton | C. O. Truxton | Other | Nationwide |
| Drug | CLASS I | Phenobarbital Tablets USP, 30 mg recalled by C. O. Truxton | C. O. Truxton | Labeling Errors | Nationwide |
Other Amitriptyline recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amitriptyline HCl USP for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
| Drug | CLASS III | Amitriptyline HCl Tablets, USP 25 mg recalled by Sandoz IncorporatedAmitriptyline Hydrochloride | Sandoz Incorporated | Packaging Defects | Nationwide |