Safety Alerts & Recalls

What does this mean?

At this time, there have been no reports of problems with these recalled Sotret 40 mg capsules. However, since the recalled capsules do not meet manufacturing standards, you may wish to check your prescription to see if your capsules are involved in the recall. If you are taking Sotret 40 mg capsules, check your prescription to see if they are lot number 1927440. The lot number can often be found on the prescription pack or the blister packaging. If you think your capsules are involved in the recall or if you do not know, please return your prescription to your pharmacist to examine and possibly exchange.

If you have any questions or concerns about this recall, please follow up with your doctor or pharmacist. If you think you may be experiencing side effects from your Sotret, please contact your doctor as soon as possible.

Recall of a Single Lot of Ranbaxy Sotret (Isotretinoin) 40 mg Capsules

Ranbaxy, Inc. is recalling a single lot of Sotret (isotretinoin) 40 mg capsules with the product code NDC 10631-586-3. Lot number 1927440 (Exp 06/10) is being recalled because the capsules in this lot did not meet manufacturing standards.

Sotret contains the active ingredient isotretinoin and is primarily used for the treatment of severe acne. No other lots, strengths, or brands of isotretinoin (marketed as Amnesteem, Claravis, and Sotret) were involved in this recall.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-11-20
Last Updated: 2009-12-05

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