Hikma Pharmaceuticals USA Inc. recalls Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by:
Hikma Pharmaceuticals recalls 0.3 mg/mL Buprenorphine HCl injection vials due to sub-potent drug levels found in stability testing. Affected lots expire 02/28/2021.
Lower-risk recall
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Contact the company & request your remedy
What happened, in plain English
Hikma Pharmaceuticals is recalling Buprenorphine HCl injection vials that tested sub-potent due to assay results from stability testing. This could mean the medication is less effective than labeled, potentially requiring higher doses for treatment. Read more at govinfonow.com/recall/36842-hikma-buprenorphine-injection-recall-sub-potent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36842-hikma-buprenorphine-injection-recall-sub-potent-drug-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1533-2020
Cite this page
“Hikma Buprenorphine Injection Recall: Sub-potent Drug Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/36842-hikma-buprenorphine-injection-recall-sub-potent-drug-risk. Based on FDA recall #D-1533-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1533-2020%22&limit=1).
Why it’s dangerous
The drug tested below the specified potency level during stability testing. This means the medication may not work as intended, requiring higher doses for the same effect. However, it does not pose an immediate safety risk like injury or death.
Who’s affected
Prescription patients using the recalled Buprenorphine HCl injection vials for pain management. Healthcare providers who dispensed these vials are also affected.
How to tell if you have this one
Check for vials labeled 'Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL' with lot numbers 2005023.1, 2005024.1, or 2005025.1 that expired by February 28, 2021.
- Brand
Hikma Pharmaceuticals- Category
Drug
What to do — step by step
Check Vial Details
Look for the lot numbers 2005023.1, 2005024.1, or 2005025.1 on the vial label.
Questions people ask
Is this product dangerous?
No immediate safety risk like injury or death, but the drug may be less potent than labeled, requiring higher doses for effectiveness.
What should I do if I have this product?
Check the lot numbers on the vial. If it matches 2005023.1, 2005024.1, or 2005025.1, contact Hikma Pharmaceuticals for instructions.
How can I tell if I have the recalled product?
The product has lot numbers 2005023.1, 2005024.1, or 2005025.1 and expires by February 28, 2021.
Contact Hikma Pharmaceuticals
We’ve drafted a message you can send Hikma Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1533-2020 — Hikma Pharmaceuticals Hikma Pharmaceuticals Hello, I own a Hikma Pharmaceuticals that is covered by recall D-1533-2020 from Hikma Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-1533-2020 (August 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1533-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.