Sandoz Amitriptyline 25mg Tablets Recall: Cross Contamination Risk
Sandoz recalls 25mg Amitriptyline HCl tablets due to cross contamination with imipramine. Affected lots expire August 2019. Consumers should contact Sandoz for details.
Lower-risk recall
Cross Contamination With Other Product: Imipramine
Contact the company
What happened, in plain English
Sandoz is recalling 25mg Amitriptyline HCl tablets that may contain imipramine due to cross contamination. This could cause unintended medication effects if taken. The recall affects specific lot numbers and expiration dates. Read more at govinfonow.com/recall/41557-sandoz-amitriptyline-25mg-tablets-recall-cross-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41557-sandoz-amitriptyline-25mg-tablets-recall-cross-contamination-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0943-2017
Cite this page
“Sandoz Amitriptyline 25mg Tablets Recall: Cross Contamination Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41557-sandoz-amitriptyline-25mg-tablets-recall-cross-contamination-risk. Based on FDA recall #D-0943-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0943-2017%22&limit=1).
Why it’s dangerous
The tablets may have been contaminated with imipramine during manufacturing, which is a different medication. Taking these contaminated tablets could lead to unintended medication effects or interactions.
Who’s affected
People who have the specific lot numbers of 25mg Amitriptyline HCl tablets from Sandoz, with expiration dates of August 2019. Those using these tablets for medical treatment are most at risk.
How to tell if you have this one
Check the product label for the lot numbers: GR3831 or GR3832, and expiration date of August 2019. The tablets are 25mg Amitriptyline HCl, packaged in 100-count or 1000-count bottles.
- Brand
Sandoz- Category
Drug
What to do — step by step
Check Product Details
Look for lot numbers GR3831, GR3832, and expiration date August 2019 on the tablet packaging.
Contact Sandoz
Reach out to Sandoz for further instructions on what to do with the recalled tablets.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed throughout the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these tablets?
The recall does not require immediate discontinuation; contact Sandoz for specific instructions.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0943-2017 (June 16, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0943-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.