Limited official informationFDA Drug Enforcement ReportsRecall date: May 20, 2026

Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 4...

Full official product description

Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.

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Compare the complete identifiers. Name similarity alone is not a confirmed match.

Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.

Affected variants from the official event record
Product or model	Codes and lots	Quantity	Recall number
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.	Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027	34,293 vials	D-0527-2026

The agency's statement is shown without a site-authored severity score.

Crystallization; identified as Buprenorphine free base

Agency classification: Class II

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

The linked agency record controls if any information differs.

Official scope

USA Nationwide

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.