Endo USA Recalls Buprenorphine Hydrochloride Injection

Source: FDA · United States

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Endo USA, Inc. is voluntarily recalling two lots of Buprenorphine Hydrochloride Injection due to the presence of particulate matter identified as Buprenorphine free base.

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

This notice was issued by FDA on June 2, 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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

Endo USA, Inc. initiated a voluntary recall of Buprenorphine Hydrochloride Injection after particulate matter identified as Buprenorphine free base was found in the product.

Which Products Are Affected

Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, NDC 42023-179-05. Affected lots are 84132 (Exp 02/28/2027) and 87693 (Exp 03/31/2027). A total of 34,293 vials are affected. The product was distributed nationwide in the United States. Recall number D-0527-2026. Classification: Class II.

What You Should Do

Consumers and healthcare providers should check product lots and contact their pharmacist or healthcare provider regarding the recall.

Why This Matters

The presence of particulate matter in an injectable drug may pose a risk of adverse events if administered.

Source

FDA recall notice - Recall D-0527-2026, report date 20260520.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Endo USA, Inc. is voluntarily recalling two lots of Buprenorphine Hydrochloride Injection due to the presence of particulate matter identified as Buprenorphine free base.
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.