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# Action Against BPI Methylene Blue Injection Asked
- URL: https://www.fdaweb.com/action-against-bpi-methylene-blue-injection-asked/
- Published: 2023-12-07T12:00:00.000Z
- Updated: 2026-09-14T14:18:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155941

Zydus Pharmaceuticals is asking FDA to “investigate and take prompt enforcement action against methylene blue injection of BPI Labs.” A 12/6 [citizen petition](https://downloads.regulations.gov/FDA-2023-P-5366-0001/attachment%5F1.pdf?ref=fdaweb.com) says the BPI product currently on the market has not been evaluated by FDA for safety or efficacy.

The petition says that similar products have been the subject of FDA Warning Letters for safety reasons. It also claims that unapproved methylene blue injection is marketed with claims to treat or cure serious diseases like drug-induced methemoglobinemia. “However,” it says, “there is no scientific evidence to support these claims. In fact, some of these products may actually make the condition worse. We believe FDA has a responsibility to remove these unapproved products from the market.”

Among the specific FDA actions requested by Zydus are that the agency:

- inspect BPI and its contract manufacturers to ensure compliance with current good manufacturing practices (CGMPs) including compliant pharmacovigilance systems to timely manage and report complaints and adverse events;
- inspect the BPI active pharmaceutical ingredient supplier to ensure compliance with CGMPs;
- remove from the market unapproved methylene blue injection products that pose a health and safety risk to the public;
- remove from the market any unapproved methylene blue injection that lack evidence of effectiveness and safety, including those that compete with a drug lawfully marketed under an FDA-approved ANDA/NDA;
- stop BPI’s importation of unapproved methylene blue injection and associated active pharmaceutical ingredients;
- issue a mandate requiring BPI to apply for FDA approval for its methylene blue injection;
- ensure the establishment of a pharmacovigilance system for BPI’s unapproved methylene blue injection to monitor severity and side effects associated with it;
- require BPI to submit data and information about the safety of its unapproved methylene blue injection to establish that the product’s labeling contains appropriate precautions, warnings, contraindications, and adverse reaction information consistent with the labeling for the approved product; and
- declare BPI’s product to be not generally recognized as safe and effective for its referenced uses and therefore is legally considered to be an unapproved new drug.