Teva Recalls Octreotide Acetate Kits Over Sterility Concerns

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Teva Pharmaceuticals USA is voluntarily recalling 2,200 kits of Octreotide Acetate for Injectable Suspension due to lack of assurance of sterility.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 24, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, drugs) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Teva Pharmaceuticals USA, Inc. initiated a voluntary recall of Octreotide Acetate for Injectable Suspension after quality system deficiencies were identified during a routine FDA inspection at the contract manufacturer, resulting in a lack of assurance of sterility.

Which Products Are Affected

The recall affects Octreotide Acetate for Injectable Suspension, 30 mg, in single-dose kits for gluteal intramuscular use. Each kit contains an 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1" 19-gauge safety injection needle. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21. Lot: 45011002, Exp. 03/31/2027. 2,200 kits distributed nationwide in the USA. Recall number D-0519-2026.

What You Should Do

Consumers should stop using the affected product and contact Teva Pharmaceuticals for return or refund instructions.

Why This Matters

This Class II recall addresses a potential sterility issue with a prescription drug distributed nationwide.

Source

FDA recall D-0519-2026; Teva Pharmaceuticals USA, Inc.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Teva Pharmaceuticals USA is voluntarily recalling 2,200 kits of Octreotide Acetate for Injectable Suspension due to lack of assurance of sterility.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.