Agency classClass IIOur severity:Severe FDA (Drugs)·D-0866-2016·Announced 2016-06-01

Fresenius Kabi Recalls Octreotide Acetate Injection Due to Impurities

Fresenius Kabi is recalling specific lots of Octreotide Acetate Injection because they failed impurities and degradation specifications.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the provided rubric, as it involves a potential for temporary or medically reversible adverse health consequences.

Plain-English summary

Fresenius Kabi USA, LLC is recalling 355,150 vials of Octreotide Acetate Injection, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial. The recall involves Lot # 6108322 (Exp. 04/16) and Lot # 6108824 (Exp. 07/16). The product was distributed nationwide and in Puerto Rico.

The recall was initiated because the product failed impurities and degradation specifications. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should stop using the affected lots and contact their healthcare provider for further instructions. Consumers should not use the recalled product and should return it to the pharmacy or contact the manufacturer for a replacement or refund.

The recalled product

Product: OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.
Manufacturer: Fresenius Kabi USA, LLC
Category: Drug — Injectable Medication
Hazard: impurities
degradation
Affected units: 355,150

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Lot # 6108322
Exp. 04/16 Lot # 6108824
Exp. 07/16

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Fresenius Kabi USA, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Fresenius Kabi USA, LLC

See all →

Severe
Fresenius Kabi Recalls Tyenne Injection Due to Glass Particles
FDA (Drugs) · 2026-09-02
Critical
Fresenius Kabi Recalls Morphine Syringes Due to Labeling Error
FDA (Drugs) · 2026-08-26
High
Naropin Injection Recall Over Particulate Matter Contamination
FDA (Drugs) · 2026-07-29
Moderate
Glycopyrrolate Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
High
Xylocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29

Same hazard · impurities