Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Is Octreotide recalled?
Yes — there is an active recall. 4 ongoing FDA recalls mention Octreotide (11 total). Check the affected lots below.
Most common reason: Sterility / contamination (7 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Octreotide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Octreotide recalls in 2026
4 initiated in 2026, 11 in total — newest first
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class I · High risk
Octreotide Acetate Injection 500 mcg/mL
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Class II · Moderate risk
Octreotide Acetate Injection 50 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Octreotide Acetate Injection 100 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Octreotide Acetate Injection 1000 mcg/5mL
Lack of Assurance of Sterility
Class II · Moderate risk
Octreotide Acetate Injection
Failed Impuities/Degradation Specifications
Class II · Moderate risk
Octreotide Acetate Injection
Failed Impuities/Degradation Specifications
Class II · Moderate risk
Octreotide Acetate Injection
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.