Endo USA Recalls Buprenorphine Hydrochloride Injection
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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 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
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 ↗
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 (929 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.