Recall of Octreotide Acetate Injection by Teva Pharmaceuticals
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Teva Pharmaceuticals is recalling 1,897 cartons of Octreotide Acetate for Injectable Suspension due to potential lack of sterility assurance.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 7, 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.
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What Happened
Teva Pharmaceuticals USA, Inc. is recalling Octreotide Acetate for Injectable Suspension because of quality system deficiencies identified during a routine FDA inspection at the contract manufacturer, leading to a lack of assurance of sterility.
Which Products Are Affected
The affected products are Octreotide Acetate for Injectable Suspension, 10 mg, Single-dose 8 mL vial, with NDC codes including 0480-9257, 0480-9259, and 0480-9262. Specific lots involved are 4401619 (expiration date 09/30/2026) and 4501005 (expiration date 03/31/2027). A total of 1,897 cartons are affected, distributed nationwide in the USA.
What You Should Do
Consumers should stop using the affected product immediately and contact Teva Pharmaceuticals USA, Inc. for instructions on returns or refunds. Reach out to them at 400 Interpace Pkwy Bldg A, Parsippany, NJ 07054-1120, as initially notified via letter.
Why This Matters
This recall ensures patient safety by addressing potential sterility issues in prescription drugs, which could impact health if not sterile; it underscores the need for rigorous manufacturing standards in pharmaceuticals.
Source
FDA Recall Announcement: Recall Number D-0404-2026
Original source: FDA Official Notice ↗
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