Recall Pulls 70 Generic Drugs From the Market—Here's What to Do If Your Medication Is One of Them (2024)

Key Takeaways

  • A pharmaceutical company called Akorn has issued a voluntary recall of over 70 generic medications, including prescription drugs, nasal sprays, injectables, eye drops, and more.
  • If you have any medications that have been manufactured by Akorn, experts recommend reaching out to your pharmacist or healthcare provider to discuss alternative medication options.
  • Despite the number of medications being pulled off the market, experts say most of these generic drugs are also manufactured by other companies.

Akorn Pharmaceuticals, a generic pharmaceutical manufacturer and distributor that was based in Gurnee, IL, has issued a voluntary recall of various human and animal medications after it filed for bankruptcy and closed shop in February.

According to the Food and Drug Administration (FDA), the company’s shutdown includes closing its Quality activities program that’s connected with over 70 human drugs and 9 veterinary drugs.

“The discontinuation of the Quality program means the company will not be able to support or guarantee that the products will meet all intended specifications through the labeled shelf life of the product,” the company said in a news release.

Akorn products were distributed nationwide to wholesalers, retailers, manufacturers, medical facilities, repackagers, and consumers online. However, the company stated that they are notifying distributors of the recall and are requesting that they notify their customs, consumers, and retailers.

All recalled products should be destroyed and distribution and use of any remaining product on the market should be stopped immediately, the company said.

Here’s what you need to know about which drugs and products are being recalled and what to do if your medication is one of them, according to experts.

How to Tell If Your Medication Is Manufactured by Akorn

Check the label on your prescription or medication. Almost all medications, whether in a bottle or tube, will have a label that specifies the manufacturer.

Which Medications Are Affected By The Recall?

The voluntary recall by Akorn Pharmaceuticals includes more than 70 human drugs, such as prescription medications, anti-seizure medicines, eyedrops, topical creams, pain medications, and allergy medicine, Candy Tsourounis, PharmD, a clinical pharmacist and Professor of Clinical Pharmacy at the University of California San Francisco, told Verywell.

Here’s a full list of the recalled products:

Analgesics

Analgesics, also known as pain killers, are types of medications used to relieve pain. Some of these drugs can be used to treat pain during medical procedures as well.

  • Acetaminophen & Codeine phosphate oral solution, 120 mg & 12 mg per 5 mL
  • Lidocaine Hydrochloride jelly USP, 2%

Antivirals

Antivirals are medications used to treat infections caused by certain types of viruses. For example, antivirals can treat herpes, chickenpox, or influenza virus.

  • Acyclovir oral suspension, 200 mg per 5 mL
  • Amantadine Hydrochloride syrup USP, 50 mg per 5 mL

Antibiotics

Antibiotics are used to treat infections caused by bacteria, such as pneumonia, bronchitis, skin, eye, and ear infections.

  • Acetic Acid otic solution
  • Levofloxacin oral solution
  • Rifampin capsules USP, 150 mg & 300 mg
  • Sulfamethoxazole & Trimethoprim oral suspension USP, 200 mg & 40 mg per 5 mL

Eye Medications

These medications can be used to treat issues related to the eye, including eye infections, dry eyes, vision loss, glaucoma, and itchy eyes caused by allergies. Some of these medications can be used before eye surgery.

  • Apraclonidine ophthalmic solution, 0.5%
  • Artificial Tears
  • Atropine Sulfate ophthalmic solution
  • Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment, 3.5 g
  • Cromolyn Sodium ophthalmic solution, 4%
  • Gonak Hypromellose ophthalmic solution
  • Ketorolac Tromethamine ophthalmic solution, 0.5%
  • Moxifloxacin Hydrochloride solution, 0.5%
  • Neomycin & Polymyxin B sulfates & Bacitracin Zinc ophthalmic ointment
  • Olopatadine solution, 0.1% & 0.2%
  • Pilocarpine, 1%, 2%, & 4%
  • Sodium Chloride ophthalmic ointment
  • Sodium Chloride solution drops
  • Timolol Maleate ophthalmic solution, 0.5%, 2.5, 5, 10, & 15 mL
  • Tobramycin ophthalmic solution, 0.3%
  • Tropicamide ophthalmic solution, 0.5% & 1%

Hair, Skin, and Nail Medications

These medications can be used to treat psoriasis, red, scaly patches, dry skin on the head or scalp, fungal infections of the nails or toenails, eczema, dry skin, burns, or bites.

  • Calcipotriene scalp solution, 0.005%
  • Ciclopirox topical solution. 8%
  • Clobetasol Propionate cream, 0.05%
  • Clobetasol Propionate ointment, 0.05%
  • Clobetasol Propionate shampoo, 0.05%
  • Lidocaine 2.5% & Prilocaine 2.5% cream
  • Lidocaine ointment

Injectables

These injections can be used for various things, including the treatment of high blood pressure, seizures, nausea, and vomiting.

  • Calcitriol injection, 1 mcg & 2 mcg
  • Cetrorelix Acetate for injection, 0.25 mg,single-dose vial
  • Ephedrine injection, 50 mg/mL
  • Granisetron Hydrochloride injection 1 mg/mL
  • Hydralazine Hydrochloride injection
  • Hydromorphone high potency injection USP(ampule and vial)
  • IC-Green Sterile Indocyanine Green injection USP
  • Levetiracetam injection USP, 500 mg per 5 mL single-dose vial
  • Levofloxacin injection, 25 mg/mL
  • Lorazepam injection, 2 mg/mL vial
  • Midazolam injection USP, 1 mg/mL & 5 mg/mL vial
  • Naloxone injection 0.4 mg/mL; 1 mL & 10 mL vial
  • Ropivacaine Hydrochloride injection USP, 2 mg/mL and 5 mg/mL
  • Fentanyl Citrate injection
  • Sufenta (Sufentanil Citrate injection, USP), 50 mcg/mL

Nasal/Nose Medications

Nasal medications can be used for seasonal allergies, sneezing, or nasal congestion.

  • Azelastine Hydrochloride nasal spray, 0.1%
  • Fluticasone Propionate nasal spray, 50 mcg/spray
  • Olopatadine Hydrochloride nasal spray, 665 mcg/spray
  • Promethazine Hydrochloride oral solution

Respiratory/Lung Medications

These types of drugs are used to treat different respiratory issues like breathing problems, asthma, wheezing, coughing, or shortness of breath.

  • Albuterol Sulfate syrup, 2.4 mg per 5 mL
  • Guaifenesin and Codeine Phosphate liquid
  • Promethazine Hydrochloride & Codeine Phosphate oral solution
  • Tobramycin inhalation solution USP, 300 mg/5 mL
  • Xopenex (levalbuterol hydrochloride solution, concentrate)

Stomach/Gastrointestinal Medications

These medications can be used to treat and stop ulcers in the stomach, help with bowel syndrome, soften the stool, alleviate constipation, or help with high blood pressure.

  • Cimetidine Hydrochloride oral solution (to treat and prevent ulcers in the stomachand duodenum)
  • Dicyclomine Hydrochloride injection USP, 20 mg/2 mL
  • Diuril (Chlorothiazide) injection
  • Docu Liquid (Docusate Sodium liquid)
  • Lactulose Syrup oral and oral/rectal
  • Sodium Diuril (Chlorothiazide Sodium) injection

Other Medications

Some of these medications are supplements while others are drugs used to help with seizures, muscle stiffness, anxiety, ear infections, or weight loss.

  • Ferrous Sulfate iron supplement drops
  • Hydrocortisone and Acetic Acidotic solution
  • Levocarnitine oral solution, USP
  • Lidocaine Hydrochloride oral topical solution, USP (viscous) 2%
  • Lorazepam oral concentrate, 2 mg
  • Megestrol Acetate oral suspension, 40 mg/mL
  • Oxcarbazepine oral suspension USP, 300 mg/5 mL
  • Prednisolone Sodium Phosphate oral solution
  • Proparacaine Hydrochloride Ophthalmic Solution, 0.5%
  • Trihexyphenidyl Hydrochloride oral solution
  • Valproic Acid oral solution
  • Vitamin D supplement drops, 50 mL

What Should You Do If Your Medication Is on the List?

The first thing you should do is contact your pharmacist or local pharmacy to determine if there are similar medications that are available on the market, Tsourounis said.

“Usually, the pharmacist would get a notification that the medication is discontinued and they should be able to offer an alternative supplier or alternative product,” she said.

If your pharmacist is unable to find a similar generic medication to the one you are using from another manufacturer, Tsourounis recommends getting in touch with your healthcare provider to discuss if there are any other alternatives available.

Jack Kann, RPh, BS, Director of Pharmacy at South Shore University, told Verywell if Akorn is the only supplier of a specific generic drug, patients will need to have a discussion with their provider to get a new prescription for something else.

“If anyone has any Akorn products at home, call your pharmacy as soon as possible and follow up with your prescriber,” Kann said. “We cannot recommend continuing on with those medications, but they shouldn’t just discontinue the medication either. They need to engage in a conversation with their healthcare professional.”

How Concerning Is the Company’s Shutdown and Drug Recall?

Since most of the drugs being recalled are generics, Tsourounis said that they should still be widely available from other pharmaceutical companies and used by many other patients.

“There’s nothing on this list that makes me say ‘oh my goodness, we’re in trouble’ because many of these medicines have been around for a long time and we have other generic manufacturers who make them,” Tsourounis said. She does acknowledge, however, that there could be some medications on the list that are not manufactured or produced by other companies.

Despite this, Kann noted that the loss of Akorn Pharmaceuticals may lead to drug shortages if other generic manufacturers cannot meet the needs of the consumers who were previously treated with medications prepared by Akorn.

“For other generic manufacturers, it depends on what their manufacturing is and how much extra ability they have in their manufacturing plants to pick up and make additional products,” Kann said. “It may also take some time to ramp up with some of these medications, so product may not be available today, but it may be available within a few weeks.”

What This Means For You

If any of your medications are recalled, experts recommend contacting your pharmacist to see if there are alternative products or suppliers. If there is no similar generic alternative, you should contact your healthcare provider to discuss other medication options.

Recall Pulls 70 Generic Drugs From the Market—Here's What to Do If Your Medication Is One of Them (2024)

FAQs

Recall Pulls 70 Generic Drugs From the Market—Here's What to Do If Your Medication Is One of Them? ›

What This Means For You. If any of your medications are recalled, experts recommend contacting your pharmacist to see if there are alternative products or suppliers. If there is no similar generic alternative, you should contact your healthcare provider to discuss other medication options.

What to do if your medication is recalled? ›

The bottom line

Contact your pharmacy and prescriber if you've been impacted by a recall. You may be able to get a replacement from an unaffected lot. Or, your prescriber may have you continue the medication, stop taking it, or switch you to another treatment.

Why would a medication likely be withdrawn from the market? ›

A drug recall occurs when a medication is removed from the market because the medication is deemed to be defective or possibly harmful. A market withdrawal occurs when a product has a minor violation that would not be subject to FDA legal action. The company removes the product from the market or corrects the problem.

What is removing medications from the market and returning them to the manufacturer called? ›

A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA).

What is the drug recall process? ›

Recall is an action taken to withdraw/remove the drugs from distribution or use including corrective action for which deficiencies are reported in quality, efficacy or safety. The defective products related to quality includes Not of Standard Quality, Adulterated or Spurious drugs.

What do I do if I make a medication error? ›

What to do when medication goes wrong
  1. Stay calm.
  2. Be honest.
  3. Seek medical advice.
  4. Document everything.
  5. Report the incident to your manager.
Aug 12, 2022

What is the FDA recall policy? ›

FDA-Industry Co-operation

Usually, the company will comply. If the firm does not recall the product, then FDA can seek legal action under the FD&C Act. These include seizure of available product, and/or injunction of the firm, including a court request for recall of the product.

What medicine is being recalled in 2024? ›

Medicine Recalls and Notifications

In April 2024, recalls and notifications for medicines were issued on: Class 3 Medicines Recall: Bristol-Myers Squibb Pharmaceuticals Limited, OPDIVO 10 mg/mL concentrate for solution for infusion (nivolumab), EL(24)A/11. Issued 4 April 2024.

What is the difference between a recall and a withdrawal? ›

A withdrawal is when unsafe food is removed from the supply chain before it has reached consumers. A recall is when unsafe food is removed from the supply chain and consumers are advised to take appropriate action, for example, to return or dispose of the unsafe food.

Why are pharmacies out of so many medications? ›

Drug Shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. Manufacturers provide FDA most drug shortage information, and the agency works closely with them to prevent or reduce the impact of shortages.

What is the action taken to remove a drug from the market and have it returned to the manufacturer? ›

Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.

Which medicine is banned in the US? ›

Which medicine is banned in the USA?
  • 1) Oxyphenbutazone. Oxyphenbutazone is a drug that is a non-opioid painkiller. ...
  • 2) Nimesulide. ...
  • 3) Propoxyphene. ...
  • 4) Nitrofurazone. ...
  • 5) Nandrolone Decanoate. ...
  • 1) Valdecoxib. ...
  • 2) Pemoline. ...
  • 3) Sibutramine.
Jan 31, 2022

What drugs have been pulled from the market? ›

Significant withdrawals
Drug nameWithdrawnRemarks
Flupirtine2018Liver toxicity.
Gatifloxacin2006Increased risk of dysglycemia.
Gemtuzumab ozogamicin (Mylotarg)2010No improvement in clinical benefit; risk for death. Returned to market in 2017.
Glafenine1984Anaphylaxis.
115 more rows

What to do when a medication is recalled? ›

What to Do if a Drug You're Taking Is Recalled
  1. Don't panic. Remember that most drug recalls are for minor issues.
  2. Get educated. To find out more about drug recalls, visit the FDA website. ...
  3. Play it safe. ...
  4. Safely discard recalled drugs. ...
  5. Call your doctor.
Mar 31, 2024

Which drug recall is the most serious? ›

Class I Recalls by the US Food and Drug Administration (FDA) are the most severe type of FDA recall. In a Class-I recall there is a potential for serious injury or death.

Can you sue for a drug recall? ›

If you suffered injury from a recalled drug, in all likelihood you have a product liability suit against the drug manufacturer. Most such suits become class action lawsuits — some of them massive — that proceed in the federal courts.

Drug Recall Guide | What to Do If Your Drug Is ...Drugwatch.comhttps://www.drugwatch.com ›

If your prescription medication is on a recall list, keep taking your medication as directed until you talk to your health care provider or pharmacist. Consumer...
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug...
If the medicine you are using and being recalled is not a prescription medicine, you should first stop taking it. Then you can return the medicine to the place ...

Do you get a refund for a drug recall? ›

Additionally, a company may suggest a patient or consumer return the product to the store in which they purchased it. Stores generally have a return and refund policy when a company announces a product recall.

What do you do with medication that has been tampered with? ›

If you find a prescription package that has a break in its integrity, return it to the pharmacy and ask for assistance.

Can you sue for recall medication? ›

But sometimes, the recalls are due to more serious problems, including contamination, incorrect dosages, or severe side effects and injuries. When people suffer serious harm after taking dangerous medications, they can file compensation claims against the pharmaceutical companies that make those drugs.

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