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? ›

Contact your pharmacy: If your lot number is on the recall list, your pharmacy may be able to get you a replacement medication from an unaffected lot. Your pharmacist can also suggest alternatives if you were taking an OTC product that was recalled. Contact your prescriber: Recalls may involve minor issues.

What to do if your medication is recalled? ›

If a prescription medication that you have been taking is recalled, do not panic. Stop taking the medication immediately, and call your doctor or contact a pharmacist and ask for a recommended replacement. Read the available materials from the FDA or the manufacturer to understand the reason for the recall.

How does the FDA decide if a drug may need to be recalled? ›

Health Hazard Evaluation

An evaluation of the health hazard presented by a product being recalled or considered for recall is conducted by FDA and takes into account, but need not be limited to, the following factors: Whether any disease or injuries have already occurred from the use of the product.

What is the process of medication recall? ›

A drug recall may be conducted on a company's own initiative or by FDA request. FDA's role in a recall is to oversee a company's recall strategy, assess the adequacy of the company's action and classify the recall. Visit recalls background and definitions page to learn about recall classifications.

What is a best practice when handling drug recalls? ›

  • Effective recalls.
  • Establish recall procedures and train staff.
  • Know FDA contacts and resources for guidance.
  • Communicate early and transparently to FDA.

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

Speaking with the patient and the family about an error has been shown to generally reduce the incidence of lawsuits. Nevertheless, be sure to follow your facility's policy. Once the patient is taken care of, report the error according to your organization's policy.

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. When you open the outer packaging at home, check the label to be certain the drug is what it should be and that the label is intact and contains the information you expect to see.

What happens when a product is recalled? ›

Typically, the instructions will indicate that you need to do one of the following: Return the product to the store where you bought it for a refund. Dispose of the product properly so that other people or animals cannot eat it. (This is particularly important if you opened the product.)

Which FDA 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.

When a medication has been recalled, which of the following actions should a pharmacy technician take? ›

Final answer: A pharmacy technician should notify the pharmacist of a medication recall, check and remove additional units from inventory, and inform affected patients about the recall and next steps hence, b. Notify the pharmacist about the recall and follow their instructions for handling the medication. is correct.

Can you sue for recall medication? ›

An attorney can analyze your case to let you know if you have grounds to bring a medical malpractice and/or product liability lawsuit for the recalled drug. Then, your lawyer can guide you through the legal process to pursue the justice and financial compensation that you need to move forward.

Do you get a refund for a drug recall? ›

You can return the product to the place of purchase and ask for a refund -- stores generally have return and refund policies when a recall has been issued. Your doctor or pharmacist can recommend an alternative medicine to use during the recall.

What is the procedure of recall? ›

Mandate a “stop sale.” If the product has been sold to consumers, contact the sellers (distribution) and ask them to make a listing of all consumers who received the product. Get the Recall Committee input as to how to handle all contacts outside the company, such as consumers, agents, dealers, media, etc.

Which is the most serious type of drug recall? ›

Class I recall: This is the most serious type of recall. This is when a product is removed from the market because there is a high likelihood that it will cause serious adverse health outcomes or death.

How do you handle a product recall? ›

5 Tips for an Effective Product Recall Procedure
  1. Notify regulatory agencies. ...
  2. Isolate your product. ...
  3. Contact consumers and stakeholders. ...
  4. Respond and remedy. ...
  5. Maintain brand integrity.
Nov 30, 2023

What is the most common reason for drug recall? ›

Problems during or after manufacturing can make a safe drug harmful. Examples include bacterial contamination, incorrect labeling, and improper storage. Bad behavior by drug makers may affect drug safety.

What does it mean when a drug is recalled? ›

A recall is a voluntary action taken by a company to remove a defective drug product from the market or warn patients and consumers about a potential risk. The list below includes voluntary drug recalls in which public notification has been issued. Visit FDA's role in drug recalls for more information.

What is the recall policy in a hospital? ›

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.

Top Articles
Latest Posts
Recommended Articles
Article information

Author: Greg O'Connell

Last Updated:

Views: 5429

Rating: 4.1 / 5 (62 voted)

Reviews: 85% of readers found this page helpful

Author information

Name: Greg O'Connell

Birthday: 1992-01-10

Address: Suite 517 2436 Jefferey Pass, Shanitaside, UT 27519

Phone: +2614651609714

Job: Education Developer

Hobby: Cooking, Gambling, Pottery, Shooting, Baseball, Singing, Snowboarding

Introduction: My name is Greg O'Connell, I am a delightful, colorful, talented, kind, lively, modern, tender person who loves writing and wants to share my knowledge and understanding with you.