Buprenorphine HCl Injection Recall
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Par Health USA, LLC is recalling 46,334 units of Buprenorphine HCl Injection due to crystallization identified as Buprenorphine free base.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 1, 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, drug.
What Happened
Par Health USA, LLC initiated a voluntary recall of Buprenorphine HCl Injection after crystallization was identified as Buprenorphine free base.
Which Products Are Affected
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use (NDC 42023-179-05). Affected lots are 82886 (exp 09/30/2026) and 89646 (exp 05/31/2027). A total of 46,334 units were distributed nationwide in the USA.
What You Should Do
The recall was initiated voluntarily by the firm via letter. Consumers with questions should contact the recalling firm.
Why This Matters
This Class II recall affects a prescription opioid medication distributed across the United States.
Source
FDA recall number D-0596-2026
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 (784 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 1, 2026.
Frequently Asked Questions
Common questions about this FDA recall.