Drug Expiration Dates - Are Expired Drugs Still Safe to Take? (2024)

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Aug 1, 2024.

You pull a bottle of medicine from your cabinet, but see it expired a year ago. You may ask:

• Can I safely take a medication if it has reached the drug expiration date?
• Are there recommendations about the best way to store my medications?
• Which drugs should never be used past their expiration date?

For many patients, these questions arise because medications can be expensive and it is costly to frequently replace expired -- but unused -- medications. But is it safe to use medicines past their expiration date?

What does an expiration date mean?

The expiration date is the final day that the manufacturer guarantees the full potency and safety of a medication.

Drug expiration dates exist on most medication labels, including prescription, over-the-counter (OTC) and dietary (herbal) supplements. U.S. pharmaceutical manufacturers are required by law to place expiration dates on prescription products prior to marketing.

For legal and liability reasons, manufacturers will not make recommendations about the stability of drugs past the original expiration date.However, for most drugs, it's just an arbitrary date, usually 1 to 5 years out, that the manufacturer selects to test drug stability. Once the container of medication is opened after production, that expiration date is no longer guaranteed.

How are drug expiration dates determined?

The expiration date of a drug is estimated using stability testing under good manufacturing practices as determined by the Food and Drug Administration (FDA).

Drug products marketed in the US typically have an expiration date that extends from 12 to 60 months from the time of manufacturer. Once the original container is opened, either by the patient or the health care provider who dispenses the drug, that original expiration date on the container can no longer be relied upon; but the actual shelf life of the drug may be much longer as stability studies have shown.

At the pharmacy, "beyond-use" dates are often put on the prescription bottle label given to the patient. These dates often say "do not use after..." or "discard after..." and are required by the Board of Pharmacy in many states. These dates are typically one year from the date of fill. But why would these expiration dates be different?

• According to manufacturers, the stability of a drug cannot be guaranteed once the original bottle is opened.
• Heat, humidity, light and other storage factors can affect stability.

Pharmacies, both retail and hospital, nursing homes, and consumers toss away billions of dollars of medications each year based on stamped expiration dates on stock bottles. In fact, according to one report from Allen and colleagues, hospitals alone discard over $800 million in drugs annually.

The United States Pharmacopeia (USP), the body that sets the standards for pharmaceutical quality in the U.S., recommends using "beyond use" dates. The "beyond use" date would never be later than the expiration date on the manufacturer's bottle.

Do expired medications lose their potency?

The best evidence suggesting that some drugs can last past their expiration date is from the Shelf Life Extension Program (SLEP) undertaken by the FDA for the Department of Defense.

The original purpose of the SLEP program was twofold: to determine the actual shelf life of stockpiled military medications for future use, and to save government dollars.

• Over 3000 lots, representing 122 different drug products, were assessed in the SLEP program. Potency, pH, water content, dissolution, physical appearance, or presence of impurities were assessed.
• Based on stability data, expiration dates on 88% of the lots were extended beyond their original expiration date for an average of 66 months. Of these, roughly 12% more lots remained stable for at least 4 years after the expiration date. Of these 2652 lots, only 18% were terminated due to failure.
• Examples of common drug products that were tested with no failures included amoxicillin, ciprofloxacin, diphenhydramine, and morphine sulfate injection. Drug expiration extension dates on these products ranged from 12 months to 184 months (over 15 years). Biologics are not included in the SLEP program.
• Potassium iodide (KI), which has been stockpiled in the US for a radiation emergency, showed no significant degradation over many years in the SLEP study and per a CDER guidance on shelf life published in 2004.
• In 2022, the Department of Health and Human Services (HHS) stated that expirations dates could be extended for many years for certain stockpiled influenza antivirals such as Tamiflu 30, 45 and 75 mg capsules (not generic) and Relenza inhalation powder if stored under labeled conditions and for emergency use in individual states.

There are no published reports of human toxicity due to ingestion, injection, or topical application of a current drug formulation after its expiration date, as reported by The Medical Letter.

These results suggest that many drug products may have extended shelf lives beyond their expiration date. However, it is difficult for any one consumer or health care provider to know which product in a medicine cabinet could have an extended shelf life or expiration date.

The ability for a drug to have an extended shelf life would be dependent upon the actual drug ingredients, presence of preservatives, temperature fluctuations, light, humidity, and other storage conditions.

Additionally, the drug lots tested in the SLEP program were kept in their original packaging. Once a drug is repackaged into another container, as often happens in the pharmacy, the shelf-life could decline due to environmental variations.

Is it safe to take expired medications?

The U.S. Food and Drug Administration (FDA) recommends never taking drugs beyond their expiration date as it is risky with many unknown variables. For example, how your drug is stored before and after you receive it, chemical make-up, and original manufacturing date can all affect potency of a drug.

The antibiotic tetracycline is one case in point. Former reports have been published that tied degraded tetracycline use with a form of renal tubular (kidney) damage known as "Fanconi Syndrome."

Solid dosage forms, such as tablets and capsules, appear to be the most stable dosage form past their expiration date. Drugs that exist in solution or as a reconstituted suspension, and that require refrigeration (such as amoxicillin suspension), may not have the required potency if used when outdated. Loss of potency can be a major health concern, especially when treating an infection with an antibiotic. Additionally, antibiotic resistance may occur with sub-potent medications.

Drugs that exist in solution, especially injectable drugs, should be discarded if the product forms a precipitate or looks cloudy or discolored. Liquid drugs such as eye or ear drops or solutions, oral liquids, or topical solutions may undergo evaporation of solvents over time.

Expired medications that contain preservatives, such as ophthalmic (eye) drops, may be unsafe past their expiration date. Outdated preservatives may allow bacterial growth in the solution.

Although expired medication may still work in some instances, patients are still advised not to take it. The medication might not be as strong as it needs to be to help.

Can you use an expired EpiPen?

The manufacturer states that EpiPen autoinjectors should not be used after the expiration date as the epinephrine has been shown to lose its potency. Epinephrine is an unstable chemical subject to degradation.

EpiPens are used in anaphylaxis, a life-threatening situation due to nuts and other foods, insect stings, or medications. There can be a major health threat or risk of death linked with an expired EpiPen. Always keep up with refills for injectors before they expire to prevent a mishap due to a subpotent medication. Check with your healthcare provider about using an out-of-date EpiPen.

The FDA requires that epinephrine autoinjector expiration dates ensure that the devices contain at least 90% of the original dose of epinephrine.

• In a study of over 30 pens that had expired up to 7.5 years earlier, the decrease in epinephrine content was proportional to the number of months past the expiration date.
• Another small study found that out of 46 autoinjector devices, 80% (37 devices) still retained 90% epinephrine content after a median expiration date of two years. Devices up to 6 months past the labeled expiration date maintained 100% of epinephrine content. The authors do note that they did NOT test the expired injectors’ effectiveness during an anaphylaxis emergency.
• In one study of over 100 outdated pens up to 11 years past expiration and kept in emergency EMS vehicles, only 13% to 31% of the labeled dose remained.

Epinephrine autoinjectors are often carried in a purse or pocket from place to place and may be subject to variable heat and humidity conditions. Also, be sure to replace any epinephrine injectors that may be stored at your child's school before they expire, too.

In addition, epinephrine autoinjectors or syringes have become more affordable and are covered by most insurance carriers due to the availability of generics at the pharmacy. Manufacturers may be able to offer copays, coupons or patient assistance, as well.

Learn more: EpiPen Financial Assistance

Does naloxone (Narcan) lose it's potency?

The opioid receptor antagonist naloxone has been available as an injectable solution since the 1970's and more recently as easier-to-use nasal sprays like Narcan. These products, used to reverse an opioid overdose, are often carried or stored by first responders, including fire fighters, law enforcement and emergency medical services (EMS), as well as in households through community access programs.

A 2019 study analyzed intravenous naloxone (not nasal formulations) to determine the quality and stability of expired naloxone HCl solutions for injection. Expired samples dated from 1990 to 2018 were collected from EMS or law enforcement. Most tested samples were found to contain more than 90% of labeled naloxone, including those stored for nearly 30 years. The researchers stated that expired intravenous products may still meet USP standards and suggest further studies, especially for newer formulations.

Narcan nasal spray was first approved in 2015 as a prescription drug and in March 2023 the FDA cleared Narcan 4 mg nasal spray as the first naloxone product cleared for over-the-counter (OTC), nonprescription use.

In January 2024, the FDA reported that Emergent BioSolutions extended the shelf-life of newly manufactured Narcan (naloxone hydrochloride) 4 milligram (mg) Nasal Spray products from 3-years to 4-years. This action was taken at the request of the FDA and is the latest of multiple steps to prevent overdoses and reduce overdose-related deaths by expanding access to naloxone and other overdose reversal agents.

Which medications are unsafe after their expiration date?

There's really no way to know if a drug is safe unless its tested in a lab for potency, but here are some common sense measures:

• Insulin is used to control blood sugar in diabetes and may be susceptible to degradation after its expiration date.
• Oral nitroglycerin (NTG), a medication used for angina (chest pain), may lose its potency quickly once the medication bottle is opened. Replace products approaching their expiration date.
• Vaccines, biologicals or blood products could also be subject to quick degradation once the expiration date is reached.
• One review has noted that outdated tetracycline antibiotics, chemotherapy agents, antiviral drugs, aminoglycosides, and anticonvulsants may lead to Fanconi Syndrome.
• Medicines that look old, powdery or crumbling, drugs with a strong smell, or dried up medicine (as in the case of ointments or creams) should always be discarded (expired or not).
• Eye drops should always be disposed of after their expiration date. Do not reuse single-use eye drops, as they typically do not contain preservatives.
• Discard any expired injectable medication. If expired or not, always discard injections if cloudy, discolored or with visible floating particles.

How should I store my medicines to maintain their shelf life?

Proper storage of medications may help to extend their potency. The bathroom and medicine cabinet are not ideal places to store medications due to heat and humidity. Similarly, medications should not be left in a hot car or glovebox, or in freezing weather.

Most oral, solid medications remain most stable in dry, cool spaces away from light. Keep the prescription bottle caps tightly closed and always keep medications out of reach of children and pets.

Look at your package insert for proper storage instructions, or ask your pharmacist. Be careful to follow any instructions for refrigeration or freezing.

Bottom Line

Should patients use expired medications or not? It's always best to use medications that are NOT expired; it's just the safest route.

If a medication is essential for a chronic and potentially life-threatening disease, for example, a heart condition, cancer treatment, seizure, or severe allergy, get a new prescription before it expires and keep up with refills as needed. If you choose to take an expired medication and you notice the drug has little or no effect, the medication should be replaced immediately.

These drugs may potentially pose serious problems if they're expired:

• A biologic product
• Insulin
• A refrigerated liquid or other medicine
• Eye drops
• Injectable medicine
• A specially compounded medication
• Any drug that looks like it is degraded, crumbling, or has a bad odor should be discarded and replaced immediately; do not use.
• Discard expired injectable medications. If expired or not, always discard injections if cloudy, discolored or with visible floating particles.

Ask your pharmacist or doctor questions about expired medications who can offer the best information and advice specific to your situation. When in doubt, it's always best to get a new, unexpired medication and safely discard the old one.

This is not all the information you need to know about drug expiration dates for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.

See also

• Common Drug Side Effects
• Does grapefruit juice interact with my medications?
• Generic vs Brand Drugs: Your FAQs Answered
• How do I remember to take my medications?
• How do I stop my medication safely?
• How to Safely Dispose of Your Old Medications
• Imprint Code FAQs - For Oral Medications
• Injection Types and Sites
• Medical Conversions - How many mL in a teaspoon?
• Pill splitting - Is it safe?
• Top 5 Ways to Avoid Drug Errors
• Top 9 Ways to Prevent a Deadly Drug Interaction
• What are pharmaceutical salt names?
• What are the risks vs. benefits of medications?
• What is the half-life of a drug?
• What is the placebo effect?

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circ*mstances.

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