FDAClass IIAugust 7, 2019

Equate Night-time Sleep Aide recall: Sterility Concern

Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1

Why was Equate Night-time Sleep Aide recalled?

Microbial contamination of non-sterile product

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?

Lot #: P300456, P300475,P300482, P300489, Exp 09/30/2020

Product
Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1
Recalling firm
LNK International, Inc.
Quantity
P300456, P300475 and P300489 (Total - 13,500 liters) and P300482 - 3,600 liter
Distribution
USA Nationwide
Recall date
August 7, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls