Teva octreotide for injectable suspension recalled

Official notice

13 Jan 2026

Last checked

13 Jan 2026

Critical riskHealth Canada

An official Health Canada notice concerns Teva octreotide for injectable suspension recalled. Teva Canada Limited is recalling all strengths (lots listed above) of the prescription drug Octreotide as a precautionary measure due to deficiencies in Good Manufacturing Practices (GMP) identified at its foreign manufacturing site. GMPs ensure drugs meet the appropriate quality standards for their intended use before they are sold. The deficiencies identified could lead to potential quality issues with the products, including microbiological contamination (leading to compromised sterility), contamination with foreign particles and concerns related to dosing accuracy. Potential serious health risks associated with these deficiencies include: Skin and muscle infections at the injection site, including cellulitis or abscess Severe blood infection Blood clots Hypersensitivity reactions, including life threatening allergic reactions Inflammatory reactions/lumps at the injection site Lack of therapeutic effect due to an insufficient dose Symptoms of overdose, such as hot flushes, frequent urination, fatigue, depression, anxiety and lack of concentration, or worsened side effects. Teva Octreotide acetate for injectable suspension is a long-acting prescription medication used to treat certain hormone-related disorders, including acromegaly (a condition caused by too much growth hormone), as well as severe diarrhea and flushing caused by certain tumors. Health Canada is monitoring the company's recall and investigation, including its implementation of corrective and preventive actions. The Department will inform the public if any new health risks are identified. Published 2026-01-13.

What to do now

If you have an affected product, do not use it. Speak to your health care professional immediately to obtain an alternative or replacement product. If you are unsure whether your product is affected, check with your pharmacy. Seek medical attention if you have used this product and are experiencing symptoms of infection, or other unexpected symptoms or side effects. Return affected product(s) to the pharmacy where it was purchased for proper disposal. Consult a health care professional if you have used the affected product and have health concerns. Contact Teva Canada Limited by calling toll-free at 1-800-268-4127, option 3, or by email at druginfo@tevacanada.com, if you have questions about this recall. Report any health product-related side effects or complaints to Health Canada.

Recall number

81478

Official notice

2026-01-13

The hazard

Teva Canada Limited is recalling all strengths (lots listed above) of the prescription drug Octreotide as a precautionary measure due to deficiencies in Good Manufacturing Practices (GMP) identified at its foreign manufacturing site. GMPs ensure drugs meet the appropriate quality standards for their intended use before they are sold. The deficiencies identified could lead to potential quality issues with the products, including microbiological contamination (leading to compromised sterility), contamination with foreign particles and concerns related to dosing accuracy. Potential serious health risks associated with these deficiencies include: Skin and muscle infections at the injection site, including cellulitis or abscess Severe blood infection Blood clots Hypersensitivity reactions, including life threatening allergic reactions Inflammatory reactions/lumps at the injection site Lack of therapeutic effect due to an insufficient dose Symptoms of overdose, such as hot flushes, frequent urination, fatigue, depression, anxiety and lack of concentration, or worsened side effects. Teva Octreotide acetate for injectable suspension is a long-acting prescription medication used to treat certain hormone-related disorders, including acromegaly (a condition caused by too much growth hormone), as well as severe diarrhea and flushing caused by certain tumors. Health Canada is monitoring the company's recall and investigation, including its implementation of corrective and preventive actions. The Department will inform the public if any new health risks are identified.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

4401203R 4401202 4400915, 4501460 4401309 4401501 4401231 4401065, 4501296 4401394 4500804 4500219 4401208 4500218 4401207 4400955 4400918

Other

RA RA-81478

Recall Numbers

81478

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Affected products

Product 1

Product - Teva Octreotide for injection 10 mg/vial - kit, Lot - 4401203R 4401202 4400915

Product 2

Product - Teva Octreotide for injection 20 mg/vial - kit, Lot - 4501460 4401309 4401501 4401231 4401065

Product 3

Product - Teva Octreotide for injection 30 mg/vial - kit, Lot - 4501296 4401394 4500804 4500219 4401208 4500218 4401207 4400955 4400918

Risk / hazard

Teva Canada Limited is recalling all strengths (lots listed above) of the prescription drug Octreotide as a precautionary measure due to deficiencies in Good Manufacturing Practices (GMP) identified at its foreign manufacturing site. GMPs ensure drugs meet the appropriate quality standards for their intended use before they are sold. The deficiencies identified could lead to potential quality issues with the products, including microbiological contamination (leading to compromised sterility), contamination with foreign particles and concerns related to dosing accuracy. Potential serious health risks associated with these deficiencies include: Skin and muscle infections at the injection site, including cellulitis or abscess Severe blood infection Blood clots Hypersensitivity reactions, including life threatening allergic reactions Inflammatory reactions/lumps at the injection site Lack of therapeutic effect due to an insufficient dose Symptoms of overdose, such as hot flushes, frequent urination, fatigue, depression, anxiety and lack of concentration, or worsened side effects. Teva Octreotide acetate for injectable suspension is a long-acting prescription medication used to treat certain hormone-related disorders, including acromegaly (a condition caused by too much growth hormone), as well as severe diarrhea and flushing caused by certain tumors. Health Canada is monitoring the company's recall and investigation, including its implementation of corrective and preventive actions. The Department will inform the public if any new health risks are identified.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Teva Canada Limited by calling toll-free

Phone

1-800-268-4127

Brand: All Strengths Of Teva Octreotide For Injectable Suspension Kit With The Lot Numbers Noted Below. Contact: Teva Canada Limited by calling toll-free. Phone 1-800-268-4127.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

App estimate

critical

Recall details

Recall number

81478

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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