Par Sterile Products Recalls Buprenorphine Injections Due to Crystallization Risk
Par Sterile Products recalls buprenorphine injections with crystalline particulates that could cause injection site reactions. Affected lots from 2018-01 to 2018-10 are included in this recall.
Lower-risk recall
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
Contact the company
What happened, in plain English
Par Sterile Products is recalling buprenorphine injections that may contain crystalline particles. These particles could cause injection site reactions if the product is used. The recall affects specific lots manufactured between January and October 2018. Read more at govinfonow.com/recall/41636-par-sterile-products-recalls-buprenorphine-injections-due-to-crystallization-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41636-par-sterile-products-recalls-buprenorphine-injections-due-to-crystallization-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0698-2017
Cite this page
“Par Sterile Products Recalls Buprenorphine Injections Due to Crystallization Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41636-par-sterile-products-recalls-buprenorphine-injections-due-to-crystallization-risk. Based on FDA recall #D-0698-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0698-2017%22&limit=1).
Why it’s dangerous
The injections may contain white crystalline particles that adhere to the vial. These particles could cause injection site reactions when the product is administered.
Who’s affected
Patients prescribed buprenorphine injections for opioid use disorder are affected. Those using the recalled lots are most at risk.
How to tell if you have this one
Check for the product name 'Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial' with NDC 42023-179-01. The affected lots range from 821102 to 824183 with expiration dates from January 2018 to October 2018.
- Brand
Par Sterile Products- Category
Drug
What to do — step by step
Check Product Lot Number
Look for the lot numbers 821102, 821103, 821104, 821106, 821107, 821108, 821884, 821885, 821886, 821887, 822767, 824183 on the vial.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the 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 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- 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-0698-2017 (April 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0698-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.