Pfizer Us Pharmaceutical Group Advil PM Caplets Recall

Why it was recalled

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

Product description

Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43

Lot numbers, UPCs & expiration codes

G85041

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1166-2014
Classification: Class III
Status: Terminated
Recall initiated: Feb 26, 2014
FDA report date: Mar 26, 2014
Quantity: 70,704 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Pfizer Us Pharmaceutical Group

Original FDA data

Every field from FDA enforcement report D-1166-2014, exactly as published.

Show all FDA fields

City: New York
State: NY
Status: Terminated
Country: United States
Event ID: 67617
Address: 235 E 42nd St
Code information: G85041
Postal code: 10017-5703
Report date: Mar 26, 2014
Product type: Drugs
Recall number: D-1166-2014
Classification: Class III
Recalling firm: Pfizer Us Pharmaceutical Group
Product quantity: 70,704 bottles
Termination date: Jul 10, 2015
Reason for recall: Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43
Distribution pattern: Nationwide
Recall initiation date: Feb 26, 2014
Initial firm notification: Letter
Center classification date: Mar 18, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1166-2014, published Mar 26, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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