Teva Recalls Octreotide Acetate Kits Over Sterility Concerns
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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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, drugs.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,159 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 24, 2026.
Frequently Asked Questions
Common questions about this FDA recall.