FDAClass IIIApril 26, 2017

Diphenhydramine HCl 25 mg recall: Subpotent

Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186…

Why was Diphenhydramine HCl 25 mg recalled?

Subpotent

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch #: 1404811, 1409802, 1502817, 1504808, 1509810, 1511802, 1603801, Exp. 12/12/2018.

Product
Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186…
Recalling firm
InnovaGel
Quantity
Approximately 7,920,177 capsules
Distribution
NY only
Recall date
April 26, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls