diphenhydrAMINE HCl

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Labeling: Label Mixup; diphenhydrAMINE HCl, Tablet, 25 mg may be potentially mislabeled as ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177, Pedigree: AD33897_10, EXP: 5/9/2014; ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: W002774, EXP: 6/6/2014; PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: W003511, EXP: 6/21/2014; VENLAFAXINE, Tablet, 25 mg

What was recalled

diphenhydrAMINE HCl, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904555159

Recalling firm: Aidapak Services, LLC
Origin: WA, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-483-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Diphenhydramine recalls

See all

Class II · Moderate risk Ongoing Mar 26, 2025

Unisom

Reason CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit

Chattem Inc D-0362-2025

Class II · Moderate risk Ongoing Mar 4, 2025

Unisom

Reason CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.

Chattem Inc D-0266-2025

Class III · Low risk Ongoing Dec 12, 2024