Class III · Low risk
Buprenorphine Sublingual Tablets
Labeling: Label Mix-up
Buprenorphine HCl (Buprenorphine Hydrochloride)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Crystallization; identified as Buprenorphine free base
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05
Affected NDC
42023-0179-05
Compare with the code on your package — it is the most precise check available.
Drug: Buprenorphine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Buprenorphine Hydrochloride NDC 42023-0179 |
.324 mg/mL | Injection Intramuscular|intravenous |
Par Health USA, LLC | Rx · CIII |
- Recalling firm
- Par Health USA, LLC
- NDC code
- 42023-179-05
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0596-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Buprenorphine recalls
See all
Class II · Moderate risk
Buprenorphine Hydrochloride
Crystallization; identified as Buprenorphine free base
Class II · Moderate risk
Buprenorphine Hydrochloride Injection
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II · Moderate risk
Buprenorphine Sublingual Tablets
CGMP Deviations
Class III · Low risk
Buprenorphine Transdermal System
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Other failed specification recalls from 2026
All failed specification recalls
Class II · Moderate risk
Pemrydi Rtu
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Class II · Moderate risk
Pemrydi Rtu
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Class II · Moderate risk
Dicyclomine Hydrochloride Capsules
shortfill; reports of empty capsules.
Class II · Moderate risk
Rising
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
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