Reported Aug 12, 2015 · Terminated

Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY…

Ranbaxy Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ranbaxy Inc. · 600 College Rd E Ste 2100 · Princeton, NJ · 08540-6636

Is this the product you have?

  • Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only
  • Manufactured forRANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA
  • NDC10631-133-31
Lot codes and dates
  • Lot #:14H04AA
  • Expiry02/28/2017
Amount recalled
9,229 Boxes

Where it was sold

  • Nationwide

Why it was recalled

Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 29, 2016 · Data as of Sep 19, 8:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.