Apotex Piperacillin-Tazobactam Injections May Have Lower Potency
Apotex recalls 4.5g/vial Piperacillin-Tazobactam injections due to high impurities reducing drug potency. Patients should not use these products as they may not work effectively.
Lower-risk recall
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
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What happened, in plain English
Apotex is recalling certain piperacillin-tazobactam injections because they contain high levels of impurities that reduce the drug's potency. This means the medication may not work as intended, potentially leading to ineffective treatment. Read more at govinfonow.com/recall/40555-apotex-piperacillin-tazobactam-injections-may-have-lower-potency.
Source Summary by GovInfoNow · govinfonow.com/recall/40555-apotex-piperacillin-tazobactam-injections-may-have-lower-potency · Updated October 7, 2026 · FDA enforcement record: FDA #D-0840-2018
Cite this page
“Apotex Piperacillin-Tazobactam Injections May Have Lower Potency.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40555-apotex-piperacillin-tazobactam-injections-may-have-lower-potency. Based on FDA recall #D-0840-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0840-2018%22&limit=1).
Why it’s dangerous
The injections contain high levels of impurities that reduce the drug's potency. This means the medication may not work effectively when used as intended, potentially leading to treatment failure.
Who’s affected
Patients prescribed this medication by a doctor. Those using the recalled product for infections may not receive effective treatment.
How to tell if you have this one
Check for NDC 60505-0688-4 with lots 502H001 (exp. 01/2019), 502H003-502H005 (exp. 04/2019), or 502H009-502H012 (exp. 05/2019).
- Brand
Apotex- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Nationwide in the USA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0839-2018 | Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0687-4; Lots: 501G014 Exp. 05/2018; 501G015 Exp.09/2018; 501G016, 501G017, 501G018, 501G019, 501G020, 501G021, 501G022, 501G023 Exp. 10/2018; 501G024, 501G025, 501G026, 501G027, 501G028, 501G029 501G030, Exp. 11/2018, 501H001, 501H002, 501H003, 501H004, 501H005, 501H006, 501H007, 501H008, Exp. 12/2018; 501H009, Exp. 04/2019; 501H012, 501H013 Exp. 06/2019; 501H018, 501H019, Exp. 09/2019. | 121693 vials |
| D-0840-2018 | Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4; Lots: 502H001 Exp. 01/2019; 502H003, 502H004, 502H005, Exp. 04/2019; 502H009, 502H012, Exp. 05/2019. | 13453 vials |
What to do — step by step
Check Product Details
Look for NDC 60505-0688-4 with specific lots and expiration dates listed in the recall notice.
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 5.4 years after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class I
- 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-0840-2018 (May 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0840-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.