Diphenhydramine recalls
The FDA has published 14 recalls involving Diphenhydramine since 2012. The latest was reported on 22 Feb 2023. Most were for sterility. Plastikon Healthcare has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls 14 since 2012
Last 12 months 0 reported
Class I 0 0% of total
Ongoing 1 latest 22 Feb 2023
Recalls per month, last 24 months click a bar for that month Severity split
0 0%12 86%2 14%
Why diphenhydramine is recalled
Ongoing diphenhydramine recalls 1 active
All diphenhydramine recalls, newest first 14 total Reported Class Recall Company Reason Where 22 Feb 2023 Drug CLASS II Diphenhydramine 18mg in NS Syringe, antihistamine recalled Sentara Infusion Services Sterility Nationwide 14 Sep 2022 Drug CLASS II Diphenhydramine HCl Oral Solution, 25 mg / cup recalled Plastikon Healthcare Manufacturing (CGMP) Deviations Nationwide 14 Sep 2022 Drug CLASS II Diphenhydramine HCl Oral Solution 12.5 mg / cup recalled Plastikon Healthcare Manufacturing (CGMP) Deviations Nationwide 15 Jun 2022 Drug CLASS II Diphenhydramine HCl oral solution, USP, 25 mg/ UD recalled Diphenhydramine Hydrochloride Mckesson Medical-Surgical Inc. Corporate Office Manufacturing (CGMP) Deviations Nationwide 2 Jun 2021 Drug CLASS II Banophen Diphenhydramine HCl 25 mg Antihistamine recalled Diphenhydramine Hydrochloride Cardinal Health Manufacturing (CGMP) Deviations FL, GA, SC 21 Aug 2019 Drug CLASS II Diphenhydramine 25 MG/ Ns recalled by Infusion Options Infusion Options Sterility NY 7 Aug 2019 Drug CLASS II Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg recalled Nighttime Sleep Aid LNK International Sterility Nationwide 26 Apr 2017 Drug CLASS III Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule bulk recalled InnovaGel Potency & Assay NY 8 Jul 2015 Drug CLASS II Diphenhydramine HCl, Diphenhydramine 25mg / NS syringe, Qty recalled Lincare Sterility AR 28 Jan 2015 Drug CLASS II Diphenhydramine 50 mg/ml vials recalled by Walgreens Infusion Services Walgreens Infusion Services Sterility 6 states 26 Mar 2014 Drug CLASS III Advil PM Caplets, (Ibuprofen recalled by Pfizer Us Pharmaceutical Group Advil Pm Pfizer Us Pharmaceutical Group Potency & Assay Nationwide 22 Jan 2014 Drug CLASS II diphenhydrAMINE HCl, Tablet, 25 mg recalled by Aidapak Services Aidapak Services Labeling Errors 4 states 17 Jul 2013 Drug CLASS II Diphenhydramine 50 mg/ml Injection recalled by Lowlite Investments Lowlite Investments Sterility Nationwide 22 Aug 2012 Drug CLASS II Diphenhydramine 25mg/ML Injectable recalled by Franck's Lab Inc., d.b.a. Franck's Lab Inc., d.b.a. Franck's Compounding Lab Sterility Nationwide
Should you stop taking Diphenhydramine?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.