Diphenhydramine recalls

The FDA has published 7 recalls involving Diphenhydramine since 2018. The latest was reported on 14 Sep 2022. Most were for manufacturing (cgmp) deviations. 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 recalls7since 2018

Last 12 months0reported

Class I00% of total

Ongoing0latest 14 Sep 2022

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 7 100%Class III 0 0%

Why diphenhydramine is recalled

Companies

Plastikon Healthcare229%
American Pharmaceutical Ingredients114%
Geritrex114%
LNK International114%
Cardinal Health114%
Mckesson Medical-Surgical Inc. Corporate Office114%

Brands

Diphenhydramine Hydrochloride229%
Nighttime Sleep Aid114%

By year

2022343%
2021114%
2019229%
2018114%

All diphenhydramine recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
14 Sep 2022Drug	CLASS II	Diphenhydramine HCl Oral Solution, 25 mg / cup recalled	Plastikon Healthcare	Manufacturing (CGMP) Deviations	Nationwide
14 Sep 2022Drug	CLASS II	Diphenhydramine HCl Oral Solution 5 mg / cup recalled	Plastikon Healthcare	Manufacturing (CGMP) Deviations	Nationwide
15 Jun 2022Drug	CLASS II	Diphenhydramine HCl oral solution, USP, 25 mg/ UD recalledDiphenhydramine Hydrochloride	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
2 Jun 2021Drug	CLASS II	Banophen Diphenhydramine HCl 25 mg Antihistamine recalledDiphenhydramine Hydrochloride	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
7 Aug 2019Drug	CLASS II	Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg recalledNighttime Sleep Aid	LNK International	Sterility	Nationwide
31 Jul 2019Drug	CLASS II	Diphenhydramine Oral Liquid Alcohol Free, 5 mg recalled by Geritrex	Geritrex	Sterility	Nationwide
28 Feb 2018Drug	CLASS II	Diphenhydramine HCl USP f (or prescription compounding recalled	American Pharmaceutical Ingredients	Potency & Assay	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.