Agency classClass IIOur severity:Moderate FDA (Drugs)·D-483-2014·Announced 2014-01-22

Aidapak Recalls Diphenhydramine Tablets Due to Potential Labeling Mixup

Aidapak Services is recalling diphenhydramine HCl tablets because they may be mislabeled as atorvastatin, prenatal vitamins, or venlafaxine.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (mislabeling) without reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Aidapak Services, LLC is recalling diphenhydramine HCl, 25 mg tablets (NDC 00904555159) due to a labeling mixup. The recall involves 901 tablets that were repacked and distributed in Arizona, California, Oregon, and Washington.

The diphenhydramine tablets may be potentially mislabeled as atorvastatin calcium (40 mg or 10 mg), prenatal multivitamin/multimineral, or venlafaxine (25 mg). Specific pedigree codes and expiration dates for the affected diphenhydramine lots are AD33897_13 (EXP: 5/9/2014), W002775 (EXP: 6/6/2014), W003513 (EXP: 6/21/2014), and AD67992_4 (EXP: 5/28/2014).

Consumers and healthcare providers should check their inventory for these specific NDC and pedigree codes. If found, the products should be returned to the distributor or disposed of according to local regulations. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product: diphenhydrAMINE HCl, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904555159
Manufacturer: Aidapak Services, LLC
Category: Drug — Prescription Medication
Hazard: mis-labeling
Affected units: 901

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

diphenhydrAMINE HCl
Tablet
25 mg has the following codes Pedigree: AD33897_13
EXP: 5/9/2014
Pedigree: W002775
EXP: 6/6/2014
Pedigree: W003513
EXP: 6/21/2014
Pedigree: AD67992_4
EXP: 5/28/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 273 recalled by Aidapak Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

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Same hazard · mis labeling