Unrated Drug recall · FDA · Published July 10, 2019

Equate Night-time Sleep Aide: Microbial Contamination Risk

Equate Night-time Sleep Aide (Diphenhydramine HCl) 50mg, Berry Flavor, 12 fl oz recalled due to microbial contamination. Stop using if you have the specific lot numbers listed.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1630-2019Drug LNK International ›

Recall notice

Microbial contamination of non-sterile product

Take action

Contact the company

Recalling firmLNK International, Inc.55 Arkay Dr · Hauppauge, NY 11788-3707

✎ GovInfoNow plain-language explainer

LNK International recalls Equate Night-time Sleep Aide (Diphenhydramine HCl) 50mg, Berry Flavor, 12 fl oz products due to microbial contamination. This means the product could be unsafe for consumption and should not be used. Read more at govinfonow.com/recall/38348-equate-night-time-sleep-aide-microbial-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/38348-equate-night-time-sleep-aide-microbial-contamination-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1630-2019

Cite this page

“Equate Night-time Sleep Aide: Microbial Contamination Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38348-equate-night-time-sleep-aide-microbial-contamination-risk. Based on FDA recall #D-1630-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1630-2019%22&limit=1).

The FDA announced on July 10, 2019, that LNK International, Inc. voluntarily recalled Equate Night-time Sleep Aide due to microbial contamination of the non-sterile product.

How to tell if you have it

Brand: Equate
Product: Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL)
UPC: 6 8113117595 1
Lot codes: P300456, P300475, P300482, P300489
Expiration date: 09/30/2020
Sold nationwide at Walmart Stores, Inc.

The hazard

The product poses a risk of microbial contamination because it is a non-sterile item. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show LNK International, Inc. has issued five other recalls since July 18, 2012. Recent brand recalls include a November 14, 2024 Kirkland Severe Cold & Flu recall for CGMP deviations and an October 11, 2022 Walgreens Sinus Relief product mislabeled as decongestant-free. Other recent recalls of similar products include a June 1, 2026 Beekeeper's Naturals Saline Nasal Spray recall for microbial contamination risk and an August 21, 2026 Broadway Joe's Pain Cream recall for potential contamination risk.

How to tell if you have this one

Check the product label for the berry flavor, 50mg diphenhydramine, and 12 fl oz size. Look for lot numbers P300456, P300475, P300482, or P300489 that expired by September 30, 2020.

Brand
LNK International
Product
Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the berry flavor, 50mg diphenhydramine, and 12 fl oz size on the label.
Stop Using if Recalled
If you have the specific lot numbers listed, stop using the product immediately.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.9 years after the firm started it.

Jul 10, 2019Firm started the recall
Aug 6, 2019FDA classified it Class II
Aug 7, 2019Published in FDA’s Enforcement Report
Jun 9, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/38348-equate-night-time-sleep-aide-microbial-contamination-risk">Equate Night-time Sleep Aide: Microbial Contamination Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1630-2019 (July 10, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1630-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.