CLASS III Drug recall · Reported 26 Mar 2014 · FDA Enforcement Report
Advil PM Caplets, (Ibuprofen recalled by Pfizer Us Pharmaceutical Group
Pfizer Us Pharmaceutical Group is recalling Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg), distributed nationwide in the US. The recall was initiated on 26 Feb 2014 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1166-2014
- FDA event ID
- 67617
- Recalling firm
- Pfizer Us Pharmaceutical Group, New York, NY
- Brand
- Advil Pm
- Manufacturer
- Haleon US Holdings LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 Feb 2014
- FDA classified
- 18 Mar 2014
- Reported
- 26 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 26 Feb 2014 | Recall initiated by company | |
| 18 Mar 2014 | Classified by FDA | +20 days |
| 26 Mar 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43
Where it was distributed
Nationwide
Questions about this recall
Is Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) recalled?
Yes. Pfizer Us Pharmaceutical Group recalled Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) on 26 Feb 2014. The recall is Class III and its status is Terminated. Recall number D-1166-2014.
Why was it recalled?
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Which lots are affected?
G85041
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pfizer Us Pharmaceutical Group
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg recalledPristiq | Pfizer Us Pharmaceutical Group | Other | Nationwide |
| Drug | CLASS I | Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg recalled | Pfizer Us Pharmaceutical Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Aldactone (spironolactone) tablets, USP, 100 mg recalledAldactone | Pfizer Us Pharmaceutical Group | Potency & Assay | Nationwide |