Notice names this product. ENDO USA’s Buprenorphine Hydrochloride is named in FDA Class II recall D-0527-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Crystallization; identified as Buprenorphine free base Identifying details: Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027. Units affected: 34,293 vials. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Crystallization; identified as Buprenorphine free base
Company / brand: ENDO USA recalls
Affected product: Buprenorphine Hydrochloride recall status
Official ID D-0527-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.