CLASS III Drug recall · Reported 12 Jul 2017 · FDA Enforcement Report
Amitriptyline HCl Tablets, USP 25 mg recalled by Sandoz Incorporated
Sandoz is recalling Amitriptyline HCl Tablets, USP 25 mg, distributed nationwide in the US. The recall was initiated on 16 Jun 2017 and the FDA has classified it as Class III.
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-0943-2017
- FDA event ID
- 77567
- Recalling firm
- Sandoz, Broomfield, CO
- Manufacturer
- Sandoz Inc
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Jun 2017
- FDA classified
- 6 Jul 2017
- Reported
- 12 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Antidepressants
Timeline
| 16 Jun 2017 | Recall initiated by company | |
| 6 Jul 2017 | Classified by FDA | +20 days |
| 12 Jul 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross Contamination With Other Product: Imipramine
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Product was distributed throughout the United States
Questions about this recall
Why was it recalled?
Cross Contamination With Other Product: Imipramine
Which lots are affected?
Lot #: a) GR3831, GS9690, Exp. 08/2019; b) GR3832, Exp. 08/2019.
Where was it sold?
Product was distributed throughout the United States
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS III | Focalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalin | Sandoz | Other | Nationwide |
| Drug | CLASS II | Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide | Sandoz | Manufacturing (CGMP) Deviations | Nationwide |
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| Drug | CLASS I | Buffered Penicillin G Potassium for Injection recalled by SandozPenicillin G Potassium | Sandoz | Labeling Errors | Nationwide |
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Other Amitriptyline recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amitriptyline HCL Tablets, USP 50 mg recalled by C. O. Truxton | C. O. Truxton | Labeling Errors | Nationwide |