Safety Alert: Dilaudid

Recall on a Single Lot of Hydromorphone HCl 2 mg Tablets

The ETHEX Corporation has voluntarily recalled a single lot of HYDROMORPHONE HCL 2 mg tablets. These tablets may be oversized and contain more drug than appropriate. This could result in patients receiving as much as twice the expected dosage of this drug.

The lot number involved in the recall is Lot #90219, with an expiration of March 2010.

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Source: FDA
Publication Date: 2008-Dec-24
Last Updated: 2009-Dec-05

What does this mean?

Since hydromorphone has serious side effects if overdosed, this recall should be taken seriously. These side effects include drowsiness, confusion, difficulty breathing, and low blood pressure.

If you or someone you care for is taking hydromorphone tablets, check your bottle to find out who they were made by and if it is labeled with the lot number involved in the recall. The prescription bottle often lists the manufacturer on the pharmacy label. Or, you can look at the tablets and see if they have any of the following "ETHEX" markings:

The 2 mg Hydromorphone Tablet is a blue round tablet with "2" on one side and an "E" on the other side.

If you think your tablets are made by ETHEX Corporation you should return them to your pharmacy to examine and possibly exchange. If you are not sure who has made your tablets, please take your bottle to your pharmacist for them to check as soon as possible.

If you have any other questions about the recall or if you are experiencing side effects, you should contact your physician, pharmacist, or other health care provider. Any customer inquiries related to this recall may also be addressed to ETHEX Customer Service at 1-800-748-1472, or sent via email to: customer-service@ethex.com with representatives available Monday through Friday, 8:00 am to 5:00 pm Central Standard Time (CST).


Visit the medication page for the following drugs:
Dilaudid medication page