Has ENDO USA, Inc. had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for ENDO USA, Inc. so far. Argus ingests new FDA enforcement records daily.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

FDA Class II Recall: BUPRENORPHINE HYDROCHLORIDE by ENDO USA, Inc.

Key facts

Recalling firm	ENDO USA, Inc.
Manufacturer	Par Health USA, LLC
Brand name	BUPRENORPHINE HYDROCHLORIDE
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.
Classification	Class II
Recall number	D-0527-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Crystallization; identified as Buprenorphine free base

In short: ENDO USA, Inc. recalled Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05. on 2026-05-20. FDA classified this action as a Class II recall (recall number D-0527-2026). Reason for recall: Crystallization; identified as Buprenorphine free base. Recall status: Ongoing. This is a drug-category FDA recall record. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is ENDO USA, Inc. and the affected product is described in FDA's record as: Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.. FDA's stated reason for the recall is: Crystallization; identified as Buprenorphine free base. The recall is tracked under FDA recall number D-0527-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05. -- and the recall number D-0527-2026. If it matches, stop using or distributing it and contact ENDO USA, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

ENDO USA, Inc.’s FDA history

Argus HQ has recorded 1 total FDA action tied to ENDO USA, Inc.: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Has ENDO USA, Inc. had other FDA recalls or enforcement actions?: This is the only FDA action Argus HQ has on file for ENDO USA, Inc. so far. Argus ingests new FDA enforcement records daily.
What is the FDA recall number for this event?: FDA recall number D-0527-2026.
What is the current status of this recall?: Status as recorded by FDA: Ongoing.
Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

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Full FDA history for ENDO USA, Inc.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Class II Recall: BUPRENORPHINE HYDROCHLORIDE by ENDO USA, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-endo-usa-inc-d-0527-2026

MLA

"FDA Class II Recall: BUPRENORPHINE HYDROCHLORIDE by ENDO USA, Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-endo-usa-inc-d-0527-2026.

Chicago

Argus HQ Research. "FDA Class II Recall: BUPRENORPHINE HYDROCHLORIDE by ENDO USA, Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-endo-usa-inc-d-0527-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_endo_usa_inc_d_0527_2026_2026,
  title = {FDA Class II Recall: BUPRENORPHINE HYDROCHLORIDE by ENDO USA, Inc.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-endo-usa-inc-d-0527-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗