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Unrated Drug recall · FDA · Published November 9, 2021

Par Sterile Products Recalls Buprenorphine Injections Due to Crystallization Risk

Par Sterile Products recalls buprenorphine injections that may crystallize, causing potential safety issues. This recall affects specific lots manufactured between 2021 and 2023.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0087-2024DrugPar Sterile Products ›
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Contact the company

Recalling firmPAR Sterile Products LLC870 Parkdale Rd · Rochester, MI 48307-1740
✎ GovInfoNow plain-language explainer

Par Sterile Products is recalling buprenorphine injections that could crystallize, which might lead to safety concerns. This recall affects specific lots with expiration dates from November 2021 to February 2023. Read more at govinfonow.com/recall/35571-par-sterile-products-recalls-buprenorphine-injections-due-to-crystallization-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/35571-par-sterile-products-recalls-buprenorphine-injections-due-to-crystallization-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0087-2024

Cite this page

“Par Sterile Products Recalls Buprenorphine Injections Due to Crystallization Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35571-par-sterile-products-recalls-buprenorphine-injections-due-to-crystallization-risk. Based on FDA recall #D-0087-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0087-2024%22&limit=1).

Par Sterile Products LLC recalled Buprenorphine HCl Injection due to crystallization hazards, according to the FDA. The agency announced the Class II recall on November 9, 2021.

How to tell if you have it

  • Brand: Par Sterile Products
  • Product: Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial (supplied in packages of 5 vials)
  • NDC: 42023-179-05
  • Lot No: 343716, Exp. Date: 11/2021
  • Lot No: 350565, Exp. Date: 07/2022
  • Lot No: 26921, Exp. Date: 07/2022
  • Lot No: 36227, Exp. Date: 02/2023
  • Distribution: Nationwide USA

The hazard

The recall addresses crystallization identified as Buprenorphine free base within the vials. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Par Sterile Products LLC has issued three other recalls since April 28, 2017. Other recent recalls of similar products include Par Health Buprenorphine Injection Recall: Crystallization Risk (June 12, 2026), Par Health Recalls Buprenorphine Injections Due to Crystallization (September 8, 2026), and Endo USA Buprenorphine Injection Recall: Crystallization Risk (March 13, 2026).

How to tell if you have this one

Check for the product name 'Buprenorphine HCl, Injection, 0.3mg/mL' in packages of 5 vials. Look for lot numbers 343716 (exp. 11/2021), 350565 (exp. 07/2022), 26921 (exp. 07/2022), or 36227 (exp. 02/2023).

  • Brand
    Par Sterile Products
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the lot number and expiration date on the vial packaging to determine if it is part of the recalled lots.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.9 years after the firm started it.

1. Firm started the recall: Nov 9, 202112. FDA classified it Class II: Nov 4, 202323. Published in FDA’s Enforcement Report: Nov 15, 202334. FDA terminated the recall: Sep 29, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0087-2024 (November 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0087-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA