Apotex Recalls Piperacillin/Tazobactam Vials Due to Crystallization Risk
Apotex recalls 52,398 vials of Piperacillin and Tazobactam for Injection due to potential crystallization. Check lot numbers 503B023-503C020.
Stop using this now
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Contact the company
What happened, in plain English
Apotex Corp. is recalling approximately 52,398 Pharmacy Bulk Package vials of Piperacillin and Tazobactam for Injection because the drug may crystallize when reconstituted. This precipitation can occur in the IV bag or line, which poses a serious safety risk if administered to patients. The recall affects specific lots manufactured by Hospira Healthcare India Pvt. Ltd. distributed nationwide. Read more at govinfonow.com/recall/47930-apotex-corp-recalls-piperacillin-and-tazobactam-for-injection-usp-40.
Source Summary by GovInfoNow · govinfonow.com/recall/47930-apotex-corp-recalls-piperacillin-and-tazobactam-for-injection-usp-40 · Updated October 13, 2026 · FDA enforcement record: FDA #D-835-2013
Cite this page
“Apotex Recalls Piperacillin/Tazobactam Vials Due to Crystallization Risk.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/47930-apotex-corp-recalls-piperacillin-and-tazobactam-for-injection-usp-40. Based on FDA recall #D-835-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-835-2013%22&limit=1).
Why it’s dangerous
The hazard is that the medication may exhibit precipitation or crystallization in the IV bag or line after reconstitution. If administered, these crystals could cause serious adverse events for the patient, as the integrity of the sterile injectable product is compromised.
Who’s affected
Healthcare facilities and pharmacies that purchased these specific Pharmacy Bulk Package vials are affected. Patients receiving this medication from the recalled lots are at risk of exposure to crystallized drug particles.
How to tell if you have this one
Check if you have Pharmacy Bulk Package vials of Piperacillin and Tazobactam for Injection, USP, 40.5 grams, manufactured by Hospira for Apotex Corp. Look for NDC 60505-0773-0 and the following lot numbers: 503B023 (Exp. 08/13); 503B028 through 503B033 (Exp. 11/13); 503C001 through 503C004 (Exp. 12/13); 503C009 (Exp. 01/14); 503C010, 503C011, 503C012, 503C014 (Exp. 02/14); and 503C015, 503C016, 503C017, 503C019, 503C020 (Exp. 04/14).
- Brand
Apotex- Category
Drug
What to do — step by step
Stop Using Recalled Lots
Immediately stop using any vials matching the listed lot numbers and expiration dates.
Contact Apotex Corp
Reach out to Apotex Corp. in Weston, FL for further instructions on returning or disposing of the product.
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 4.7 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.
Questions people ask
Which lot numbers are included in this recall?
The recalled lots are 503B023, 503B028-503B033, 503C001-503C004, 503C009, 503C010-503C012, 503C014, and 503C015-503C017, 503C019-503C020.
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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-835-2013 (May 10, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-835-2013 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.