FDA Drug recall D-1166-2014
Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43
- FDA Drug
- Class III
- terminated
- Published 2014-03-26
On 2014-03-26 the FDA classified a Class III recall of Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43 by Pfizer Us Pharmaceutical Group, citing subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1166-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-02-26 |
| Published | 2014-03-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pfizer Us Pharmaceutical Group |
| Distribution | US |
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
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Identifiers
| ndc | 0573-0164-33 |
|---|---|
| ndc | 0573-0164-04 |
| ndc | 0573-0164-20 |
| ndc | 0573-0164-30 |
| ndc | 0573-0164-40 |
| ndc | 0573-0164-43 |
| ndc | 0573-0164-45 |
| ndc | 0573-0164-32 |
| ndc | 0573-0164-41 |
| ndc | 0573-0164-91 |
| ndc | 0573-0164-05 |
| ndc | 0573-0164-55 |
| ndc | 0573-0164-21 |
| ndc | 0573-0164-44 |
| ndc | 0573-0164-14 |
| ndc | 0573-0164-12 |
| ndc | 0573-0164-49 |
| ndc | 0573-0164-46 |
| ndc | 0573-0164-65 |
| ndc | 0573-0164-08 |
| ndc | 0573-0164-09 |
| code_info | G85041 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1166-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.