Stop using now Drug recall · FDA · Published July 30, 2012

Genentech Trastuzumab Kit Recall: Glass Particulates in Diluent

Genentech recalls 2,140 Trastuzumab Kits due to potential glass particulates in the Bacteriostatic Water diluent vial. Check lot numbers if you have this investigational drug.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-135-2013Drug Genentech ›

Stop using this now

Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates.

Take action

Contact the company

Recalling firmGenentech Inc1 DNA Way · South San Francisco, CA 94080-4990

✎ GovInfoNow plain-language explainer

Genentech Inc. is recalling 2,140 Trastuzumab Kits distributed nationwide because one lot of the included Bacteriostatic Water for Injection diluent may contain glass particulates. This kit contains a vial of Trastuzumab and reconstitution instructions for investigational use only. The presence of glass particles in an injectable solution poses a risk to patients receiving this treatment. Read more at govinfonow.com/recall/48606-genentech-inc-recalls-trastuzumab-kit-containing-1-vial-trastuzumab-nominal.

Source Summary by GovInfoNow · govinfonow.com/recall/48606-genentech-inc-recalls-trastuzumab-kit-containing-1-vial-trastuzumab-nominal · Updated October 13, 2026 · FDA enforcement record: FDA #D-135-2013

Cite this page

“Genentech Trastuzumab Kit Recall: Glass Particulates in Diluent.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48606-genentech-inc-recalls-trastuzumab-kit-containing-1-vial-trastuzumab-nominal. Based on FDA recall #D-135-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-135-2013%22&limit=1).

The Food and Drug Administration announced on July 30, 2012, that Genentech Inc. voluntarily recalled Trastuzumab Kits due to the potential presence of glass particulate matter in the diluent vials. The agency issued recall number D-135-2013 for the Class I product.

How to tell if you have it

Brand: Genentech
Product: Trastuzumab Kit
NDC: 50242-903-69
Lot #: 454138
Trastuzumab Lot #: 886618
Bacteriostatic Water for Injection, USP Lot #: 08-368-DK-01
Expiration dates: 07/14 (diluent and Trastuzumab)
Units affected: 2,140 kits

The hazard

One lot of Bacteriostatic Water for Injection, USP diluent vials packed with the investigational Trastuzumab Kits has the potential to contain glass particulates. The FDA classified this as a Class I recall, indicating a high risk of adverse health consequences.

Context

GovInfoNow's records show Genentech, Inc. has 9 other recalls on record since 2022-10-18. Other recent recalls include the 2024-05-20 Genentech Cathflo Activase recall for deformed stoppers and the 2022-10-18 Genentech Susvimo Ocular Implant recall for a defective delivery system. Similar products have faced particulate hazards, including the 2026-08-06 Mallinckrodt Acthar Gel recall, the 2026-05-12 Sun Pharmaceutical DOXOrubin Liposome Injection recall, and the 2026-08-10 Fresenius Kabi Tyenne Injection recall.

How to tell if you have this one

Check if you have a Trastuzumab Kit manufactured by Hospira, Inc. for Genentech, Inc. Look for NDC 50242-903-69. Specifically verify the following lot numbers: Trastuzumab Lot #886618 (Exp 12/14), Bacteriostatic Water Lot #08-368-DK-01 (Exp 07/14), and Kit Lot #454138 (Exp 07/14).

Brand
Genentech
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop using the kit immediately
Do not use or administer the Trastuzumab Kit if it matches the recalled lot numbers due to the risk of glass particulates.
Contact your healthcare provider
Reach out to the medical professional managing your investigational treatment to discuss next steps and potential replacement options.

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 8 months after the firm started it.

Jul 30, 2012Firm started the recall
Jan 22, 2013FDA classified it Class I
Jan 30, 2013Published in FDA’s Enforcement Report
Mar 25, 2013FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/48606-genentech-inc-recalls-trastuzumab-kit-containing-1-vial-trastuzumab-nominal">Genentech Trastuzumab Kit Recall: Glass Particulates in Diluent (GovInfoNow)</a>

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-135-2013 (July 30, 2012) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-135-2013 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.