Reported Mar 26, 2014 · Terminated

Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940…

Pfizer US Pharmaceutical Group

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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: Pfizer Us Pharmaceutical Group · 235 E 42nd St · New York, NY · 10017-5703

Is this the product you have?

  • Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43
Lot codes and dates
  • G85041
Amount recalled
70,704 bottles

Where it was sold

  • Nationwide

Why it was recalled

Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 10, 2015 · Data as of Sep 19, 7:59 PM UTC

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