Pfizer Inc. recalls Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy
Pfizer recalls Unasyn (ampicillin/sulbacatam) injections due to particulate matter found after reconstitution. Affected items were made in Italy with specific lot numbers and expiration dates.
Use caution until it’s fixed
Presence of Particulate Matter: particulate matter identified after reconstitution.
Contact the company & request your remedy
What happened, in plain English
Pfizer is recalling Unasyn injections that may contain particulate matter after being reconstituted. This could cause serious injury if the particles enter the bloodstream during injection. Read more at govinfonow.com/recall/37088-pfizer-unasyn-injection-recall-particulate-matter-after-reconstitution.
Source Summary by GovInfoNow · govinfonow.com/recall/37088-pfizer-unasyn-injection-recall-particulate-matter-after-reconstitution · Updated October 5, 2026 · FDA enforcement record: FDA #D-1306-2020
Cite this page
“Pfizer Unasyn injection recall: Particulate matter after reconstitution.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37088-pfizer-unasyn-injection-recall-particulate-matter-after-reconstitution. Based on FDA recall #D-1306-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1306-2020%22&limit=1).
Why it’s dangerous
Particulate matter can be present in the reconstituted injection solution. If injected, these particles may cause serious injury or complications in the bloodstream.
Who’s affected
Healthcare professionals who use Unasyn injections for medical treatment. Patients receiving these injections are at risk if the particulate matter enters their bloodstream.
How to tell if you have this one
Check for vials with NDC 0049-0013-81 and cartons with NDC 0049-0013-83. The lot number is 3301612, and the expiration date is February 2022.
- Brand
Pfizer- Category
Drug
What to do — step by step
Check for Particulate Matter
Inspect the reconstituted solution for visible particles before use.
Questions people ask
Is this product safe to use?
The recall states particulate matter may be present after reconstitution, so it is not safe to use without checking for particles.
What should I do if I have this product?
The recall does not specify a remedy, so contact Pfizer directly for guidance.
How can I tell if I have the recalled product?
Look for vials with NDC 0049-0013-81 and cartons with NDC 0049-0013-83, lot number 3301612, and expiration date February 2022.
Contact Pfizer
We’ve drafted a message you can send Pfizer to request your refund or repair — edit it as you like.
Subject: Recall D-1306-2020 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-1306-2020 from Pfizer. 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-1306-2020 (May 29, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1306-2020 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.