Apotex Recalls Piperacillin and Tazobactam Due to Crystallization Risk
Apotex recalls specific lots of Piperacillin and Tazobactam for Injection due to potential crystallization. Check lot numbers and expiration dates immediately.
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Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
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What happened, in plain English
Apotex Corp. is recalling specific lots of Piperacillin and Tazobactam for Injection, USP, manufactured by Hospira Healthcare India Pvt. Ltd. The recall addresses a hazard where the medication may exhibit precipitation or crystallization in the IV bag or line after reconstitution. This issue affects 37,303 vials distributed nationwide. Read more at govinfonow.com/recall/48273-apotex-corp-recalls-piperacillin-and-tazobactam-for-injection-usp-40.
Source Summary by GovInfoNow · govinfonow.com/recall/48273-apotex-corp-recalls-piperacillin-and-tazobactam-for-injection-usp-40 · Updated October 13, 2026 · FDA enforcement record: FDA #D-806-2013
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“Apotex Recalls Piperacillin and Tazobactam Due to Crystallization Risk.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48273-apotex-corp-recalls-piperacillin-and-tazobactam-for-injection-usp-40. Based on FDA recall #D-806-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-806-2013%22&limit=1).
Why it’s dangerous
The recalled vials have the potential to exhibit precipitation or crystallization in the IV bag or IV line upon reconstitution. This physical change can compromise the safety and efficacy of the intravenous antibiotic treatment.
Who’s affected
Healthcare facilities and pharmacies that purchased specific lots of this prescription-only drug between its manufacture and the recall date are affected. Patients receiving these specific reconstituted IV doses are at risk if the medication has crystallized.
How to tell if you have this one
Look for Pharmacy Bulk Package vials labeled 'Piperacillin and Tazobactam for Injection, USP, 40.5 grams'. Check the NDC number 60505-0773-0 and verify if the lot number matches one of the following: 503B015, 503B016, 503B019, 503B020, 503B021, 503B022, 503B024, 503B025, 503B026, 503B027, 503C005, 503C006, 503C007, 503C008, or 503C018.
- Brand
Apotex- Category
Drug
What to do — step by step
Check Lot Numbers
Verify if your inventory includes any of the recalled lot numbers listed in the record.
Stop Distribution
Do not distribute or use any vials from the affected lots immediately.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- 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-806-2013 (March 18, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-806-2013 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.