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Moderate riskFDA DrugClass II

Par Health USA buprenorphine injection recalled for crystallization

Par Health USA's buprenorphine HCl injection (0.3 mg/mL) has been found to contain crystallization identified as buprenorphine free base in certain lots. This affects vials distributed nationwide. The FDA has classified this as a Class II recall.

From the FDA notice · Read the official notice ↗ · All Paragon 28 recalls

What to do

  1. Check if you have buprenorphine from Par Health USA with lot #82886 (expiration 09/30/2026) or lot #89646 (expiration 05/31/2027).
  2. Do not use affected vials.
  3. Contact your pharmacy or healthcare provider for guidance on replacement or alternative medication.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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
Sold in
Nationwide
Made for
All ages (0 months and older)

Details

Units affected
46,334 units
Illnesses reported
None reported
Manufactured in
870 Parkdale Rd, Rochester, MI, United States
Classification
Class II
Recall number
D-0596-2026

In the FDA's words

Description
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 Crystallization; identified as Buprenorphine free base Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027 Distribution: Nationwide in the USA. Affected quantity: 46,334 units
Hazard
Crystallization; identified as Buprenorphine free base

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