Understanding the Reasons: Why Was Amitriptyline Recalled?

October 9, 2025 •

3 min read

Several batches of generic amitriptyline have been recalled in recent years by regulatory bodies like Health Canada and Singapore's HSA due to quality control issues. Patients often ask, "Why was amitriptyline recalled?" to understand if their medication is affected, but it's important to differentiate specific batch recalls from the general safety profile of the medication itself.

Quick Summary

Several recalls for specific lots of amitriptyline and its brand-name version, Elavil, have occurred due to contamination with nitrosamine impurities like NDMA and NNORT, as well as labeling errors. The brand Elavil was discontinued for business reasons, not for safety concerns. Generic amitriptyline remains widely available and is considered safe when not part of an affected batch.

Key Points

Nitrosamine Impurities: The most recent recalls of amitriptyline were due to unacceptable levels of nitrosamine compounds like NDMA and NNORT found in specific batches.
Not an Immediate Risk: Health authorities confirmed that the nitrosamine impurity risk was tied to long-term, high-level exposure, and patients faced no immediate danger.
Labeling Error Recall: A separate recall in 2017 was a precautionary measure due to a label mix-up with phenobarbital tablets by one specific manufacturer.
Brand Name Elavil Discontinued: The brand name Elavil was voluntarily discontinued around 2000, but not for reasons of safety or effectiveness, as confirmed by the FDA.
Generic Amitriptyline Still Available: Despite brand discontinuation and batch-specific recalls, generic amitriptyline remains widely available and is still prescribed.
Consult a Professional: Patients with concerns about their medication should always speak to a pharmacist or doctor before making any changes.

Multiple reasons behind amitriptyline recalls

The history of amitriptyline recalls is marked by two primary issues: manufacturing contamination and labeling errors. While specific lots have been affected, the drug itself, and its generic versions, remain widely available and prescribed for various conditions. Understanding the distinct reasons for each recall helps clarify the nature of the safety issues involved.

Nitrosamine impurity recalls

Starting around 2021, several pharmaceutical manufacturers initiated recalls for certain batches of amitriptyline and its active metabolite, nortriptyline, due to the presence of nitrosamine impurities. These recalls primarily impacted products sold under generic names or brand names like Apo-Amitriptyline and Elavil.

Nitrosamines, such as N-nitrosodimethylamine (NDMA) and N-nitroso-nortriptyline (NNORT), are classified as probable human carcinogens, meaning long-term exposure above acceptable levels may increase the risk of cancer. Health authorities, including Health Canada and the Singapore Health Sciences Authority (HSA), have issued advisories and managed these recalls.

It is crucial to note that health authorities have emphasized that there is no immediate risk to patients taking the affected medication. The potential cancer risk is associated with long-term exposure to levels of impurities exceeding safety limits, not with short-term use. As a result, patients are typically advised to continue their medication and consult their pharmacist or physician rather than immediately stopping treatment.

Labeling mix-up recall

In May 2017, a voluntary nationwide recall was issued by C.O. Truxton, Inc., for specific lots of Amitriptyline HCL Tablets, USP 50mg. The recall was prompted by a potential label mix-up where bottles of amitriptyline might have been mislabeled with tablets of phenobarbital, a sedative and anticonvulsant.

This recall was not related to the quality of the medication itself but to a packaging error. A mix-up could potentially lead to serious health issues, as taking the wrong medication poses significant health risks. This particular recall has since been completed and terminated by the FDA.

Discontinuation of the brand name Elavil

The brand name version of amitriptyline, Elavil, was discontinued by its manufacturer around the year 2000. Unlike the impurity or labeling recalls, this was a business decision and was not based on safety concerns.

In 2017, the FDA officially confirmed that Elavil was not withdrawn from the market for reasons of safety or effectiveness. While the branded version is no longer sold, generic amitriptyline remains available for prescription. This distinction is important for patients who may be confused about why a familiar brand is no longer available.

Comparing reasons for amitriptyline recalls


Recall Event	Primary Reason	Affected Products	Impact on Safety	Status
Nitrosamine Impurity	Manufacturing contamination with nitrosamines (e.g., NDMA, NNORT) above acceptable levels.	Specific lots of Apo-Amitriptyline (Canada), Apo-Amitriptyline (Singapore), Elavil (Canada).	Low, long-term risk. No immediate harm, potential cancer risk with prolonged exposure above safe levels. Patients usually advised to continue unless instructed otherwise.	Recalls for specific lots have been completed. Ongoing regulatory monitoring.
Labeling Mix-up	Packaging error resulting in a label mix-up with phenobarbital.	Specific lots of Amitriptyline HCL Tablets, USP 50mg by C.O. Truxton, Inc.	Immediate potential risk if wrong medication is taken. Could lead to serious adverse effects like intoxication.	Recall completed and terminated by FDA.
Elavil Discontinuation	Brand-name drug removed from market due to a business decision by the manufacturer.	Brand-name Elavil (all dosages).	None. The drug was not withdrawn for safety or effectiveness reasons.	Discontinued. Generic versions widely available.

Conclusion: Navigating medication recalls

Recalls for amitriptyline have occurred for several different reasons over the years, most notably due to nitrosamine impurities and a past labeling mix-up. It is important to distinguish these isolated incidents, which affect specific batches, from the overall safety of the medication, which remains widely prescribed and available as a generic. Regulatory agencies have acted swiftly to inform the public and ensure patient safety while emphasizing that the risks associated with most recalls were low and related to long-term exposure. By understanding the specific reasons behind each recall, patients can stay informed and address any concerns with their healthcare provider. For additional information on medication safety and recalls, authoritative resources like the U.S. Food and Drug Administration (FDA) website are valuable resources.

Frequently Asked Questions

There is no current, blanket recall for all amitriptyline products. Recalls for specific batches have occurred in the past, primarily due to nitrosamine impurities. Patients should check with their pharmacy to confirm if their specific lot number was affected by a past recall.

A nitrosamine impurity, such as NDMA, is a substance that can form during certain drug manufacturing processes. It is classified as a probable human carcinogen, meaning long-term exposure to levels above a safe limit may increase the risk of cancer.

A brand name recall typically refers to a specific product sold under a trade name (e.g., Elavil), while a generic recall refers to products containing the same active ingredient sold under their generic name (e.g., amitriptyline). A generic manufacturer can have a recall, but other generic manufacturers and the original brand may not be affected.

The brand name Elavil was voluntarily discontinued by its manufacturer for business-related reasons and was not recalled for safety concerns. Generic amitriptyline is a therapeutic equivalent and is still widely available.

If a recall is initiated, the manufacturer will issue specific lot numbers and expiry dates for the affected products. You can compare this information, often found on the medication bottle, to the recall notice or consult your pharmacist.

No. Healthcare authorities advise against suddenly stopping your medication, as the risks associated with an untreated condition often outweigh the potential, long-term risks of impurity exposure. Always speak with your doctor or pharmacist first.

Yes, drug recalls are not uncommon and can happen for various reasons, including quality control issues, labeling errors, and discovery of potential contaminants. Regulatory agencies like the FDA and Health Canada maintain ongoing oversight to ensure drug safety.