Class II U.S. Food and Drug Administration

ENDO USA, Inc. Buprenorphine Hydrochloride, Injection, 0.3mg/mL recall: Crystallization; identified as Buprenorphine free base

Recall published 5 months ago

Crystallization; identified as Buprenorphine free base

The hazard: Drug safety concern

A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

What the notice says: Crystallization; identified as Buprenorphine free base

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0527-2026
Published
May 20, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
ENDO USA, Inc.
Product type
Prescription & OTC drugs
Units affected
34,293 vials
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027

Products covered by this recall

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

Check your product

The notice names 14 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 84132
  • Exp 02
  • 28
  • 2027

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 02
  • 28
  • 2027
  • 03
  • 31
  • 2027 — 34
  • 293 vials

NDC number

On the carton and again on the bottle or blister label.

  • 42023-179-05

Package size

Match the net weight or the piece count on the front of the pack.

  • 0.3 mg
  • 1 mL

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

ENDO USA, Inc. — A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

  1. Check the lot number on your pack against the codes listed above.
  2. Keep the carton; the lot number is often printed only on the outer pack.
  3. Report side effects you think the product caused to FDA MedWatch.
  4. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: ENDO USA, Inc. — 870 Parkdale Rd, Rochester, MI, 48307-1740

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was ENDO USA, Inc. prescription & otc drugs recalled?

Crystallization; identified as Buprenorphine free base Crystallization; identified as Buprenorphine free base

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 84132, Exp 02, 28; best-by date 02 or 28. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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