Advil PM Caplets — Class III drug recall D-1166-2014
Terminated recall by Pfizer Us Pharmaceutical Group, reported 2014-03-26, distributed nationwide. Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine ci
| Recall number | D-1166-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Us Pharmaceutical Group, New York, NY, United States |
| Recall initiated | 2014-02-26 |
| Classified | 2014-03-18 |
| Reported by FDA | 2014-03-26 |
| Terminated | 2015-07-10 |
| Distributed | Nationwide (US) |
| Quantity | 70,704 bottles |
| Reason classes | potency |
| NDC | 00573-0164, 00573-0164-04, 00573-0164-05, 00573-0164-08, 00573-0164-09, 00573-0164-12, 00573-0164-14, 00573-0164-20, 00573-0164-21, 00573-0164-30, 00573-0164-32, 00573-0164-33, 00573-0164-40, 00573-0164-41, 00573-0164-43, 00573-0164-44, 00573-0164-45, 00573-0164-46, 00573-0164-49, 00573-0164-55, 00573-0164-65, 00573-0164-91 |
Product
Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43
Reason for recall
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1166-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.