Teva Octreotide Injection Recalled Over Sterility Concerns

This alert was compiled from official government recall data published by the FDA using automated analysis. All facts are sourced directly from official records. Last verified April 7, 2026.

Nearly 20,000 cartons of Octreotide Acetate are being recalled across the United States. Yes, you read that right – 19,869 cartons to be exact. If you or someone you know uses this medication, it's important to pay attention.

Here are the quick facts about this urgent product recall in the United States:

• Product: Octreotide Acetate for Injectable Suspension, 20 mg, Single-dose 8 mL vial
• Manufacturer: Pharmathen International S.A (Greece) for Teva Pharmaceuticals USA, Inc.
• Reason: Lack of assurance of sterility.
• Affected Lots: 4401491, 4401600, 4401603, 4401629 (Exp.: 9/31/2026); 4500594, 4500786, 4500920, 4501007, 4501462 (Exp.: 3/31/2027).
• Distribution: Nationwide in the USA

Why This Recall Matters to You

Nobody wants to find out their medication might not be sterile. This isn't a minor inconvenience; the lack of sterility assurance means there's a risk of contamination, which could lead to serious infections. The recall is classified as Class II, which means that use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Teva Pharmaceuticals USA, Inc. issued this voluntary recall after quality system deficiencies were found during a routine U.S. Food and Drug Administration (FDA) inspection at their contract manufacturer, Pharmathen International S.A. It's sold across the U.S., so whether you're in California, Texas, Florida, New York, or anywhere else in the country, this recall potentially affects you. While this product isn’t typically sold at major U.S. retailers like Walmart, Target, Amazon, or Costco, it's distributed through pharmacies and healthcare providers nationwide.

Understanding the Specifics: Lot Numbers and Expiration Dates

Here’s what to look for. The recalled product is Octreotide Acetate for Injectable Suspension, packaged in a single-dose 8 mL vial. The National Drug Code (NDC) is 0480-9259-08. What's really important is checking the lot number and expiration date printed on the carton. Here are all the affected lots:

• Lot numbers 4401491, 4401600, 4401603, and 4401629, all expiring on 9/31/2026.
• Lot numbers 4500594, 4500786, 4500920, 4501007, and 4501462, all expiring on 3/31/2027.

Double-check your medication against these numbers. If you find a match, keep reading to find out what to do next.

What To Do If You Have Recalled Octreotide Acetate

If you have any of the recalled Octreotide Acetate, here's what you need to do. Don’t panic, but act quickly.

1. Stop using the product immediately and contact your healthcare provider to discuss alternative treatments or medications.
2. Contact Teva Pharmaceuticals USA, Inc. to report the recalled product and inquire about the return process; you can find their contact information on their website or through your pharmacy.
3. If you experience any adverse reactions or health concerns after using the medication, seek immediate medical attention and inform your healthcare provider about the potential contamination.
4. Keep the recalled product in a safe place, away from children and pets, until you receive instructions from Teva Pharmaceuticals on how to return or dispose of it properly.
5. Make sure to tell your doctor you've been using a recalled medication; they may want to monitor you for possible infection.

Teva Pharmaceuticals' Previous Recalls

This isn’t Teva Pharmaceuticals’ first recall. While past recalls don't relate directly to this sterility issue, it’s worth noting that companies sometimes experience recurring problems. This highlights the importance of regular FDA inspections and vigilance from American shoppers. It’s a good idea to stay informed about product recalls, even if you don’t think they affect you directly. You never know when a product you use might be included in a product recall in the United States.

Protecting Yourself as U.S. Consumers

Staying informed about recalls is a crucial part of being a responsible shopper. Here are a few tips to help you protect yourself and your family:

• Sign up for recall alerts from the FDA; this way, you'll get notifications delivered straight to your inbox.
• Regularly check the FDA website for updates on recalls, especially if you use prescription medications.
• Talk to your doctor or pharmacist about any concerns you have about medication safety.
• If you suspect a product is unsafe, report it to the FDA through their MedWatch program.

Taking these steps can help you stay one step ahead and ensure the products you’re using are safe. This recall, like many others, highlights the importance of strong quality control measures and diligent oversight to protect public health.

This recall was announced by the U.S. Food and Drug Administration (FDA). For the official notice and complete details, visit www.fda.gov.

Frequently Asked Questions

Q: What does "lack of assurance of sterility" actually mean?

It means the manufacturer couldn't guarantee that the product was completely free from harmful bacteria or other microorganisms during the production process. This increases the risk of infection if you use the medication.

Q: How do I contact Teva Pharmaceuticals about this recall?

Teva Pharmaceuticals' contact information should be available on their website or through the pharmacy where you obtained the medication; your pharmacist can assist you in finding the right contact channels for reporting the recalled product and inquiring about the return and refund process.

Q: What happens if I already used the recalled Octreotide Acetate?

Contact your healthcare provider immediately and inform them that you used a recalled medication; they can assess your risk of infection and provide appropriate medical advice or treatment if necessary.

Q: Will Teva Pharmaceuticals provide a refund or replacement for the recalled medication?

Yes, Teva Pharmaceuticals should provide a refund or replacement for the recalled Octreotide Acetate; contact them directly to understand their specific return and reimbursement process.

Q: How many recalls has the FDA issued recently?

The FDA issues many recalls each year, spanning food, drugs, medical devices, and other products; the exact number varies but generally falls in the hundreds annually, reflecting the agency's ongoing efforts to monitor and ensure the safety of products available to the U.S. public.