Class II U.S. Food and Drug Administration

Par Health USA, LLC Buprenorphine Hydrochloride, Injection 0.3 mg/mL recall: Crystallization

Recall published 18 days ago

Crystallization

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

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-0876-2026
Published
October 7, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Par Health USA, LLC
Product type
Prescription & OTC drugs
Units affected
154210 bottles
Distribution
Nationwide
Made in
United States
Lot / code info
Lot#:83912, Exp Date 10/2026 Lot#:84234, Exp Date 11/2026 Lot#:84990, Exp Date 11/2026 Lot#:85003, Exp Date 12/2026 Lot#:86443, Exp Date 01/2027 Lot#:89909, Exp Date 05/2027

Products covered by this recall

Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05

Check your product

The notice names 16 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.

  • 83912
  • 2026 Lot
  • 84990
  • 86443
  • 2027 Lot

Best-by / use-by date

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

  • 10
  • 2026 Lot
  • 11
  • 12
  • 01
  • 2027 Lot
  • 05
  • 2027 — 154210 bottles

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

Par Health USA, LLC — 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. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
  3. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  4. Keep the carton; the lot number is often printed only on the outer pack.

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: Par Health USA, LLC — 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 Par Health USA, LLC prescription & otc drugs recalled?

Crystallization Crystallization

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 83912, 2026 Lot, 84990; best-by date 10 or 2026 Lot. 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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