CLASS II Drug recall · Reported 7 Aug 2019 · FDA Enforcement Report
Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg recalled
LNK International is recalling Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, distributed nationwide in the US. The recall was initiated on 10 Jul 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1630-2019
- FDA event ID
- 83315
- Recalling firm
- LNK International, Hauppauge, NY
- Brand
- Nighttime Sleep Aid
- Manufacturer
- Wal-Mart Stores Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jul 2019
- FDA classified
- 6 Aug 2019
- Reported
- 7 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Allergy Medication
Timeline
| 10 Jul 2019 | Recall initiated by company | |
| 6 Aug 2019 | Classified by FDA | +27 days |
| 7 Aug 2019 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial contamination of non-sterile product
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Stores named: Walmart
Questions about this recall
Why was it recalled?
Microbial contamination of non-sterile product
Which lots are affected?
Lot #: P300456, P300475,P300482, P300489, Exp 09/30/2020
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from LNK International
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets recalledSevere Cold And Flu Plus Congestion | LNK International | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | LNK International products recalledSinus Pressure, Pain And Cough | LNK International | Labeling Errors | Nationwide |
| Drug | CLASS III | Nighttime Sleep-Aid (doxylamine succinate HCl) tablets recalled | LNK International | Other | Nationwide |
| Drug | CLASS III | Acetaminophen Extra Strength Pain Reliever / Fever Reducer recalled | LNK International | Other | PA |
| Drug | CLASS II | Walgreens Aspirin Free Tension Headache recalled by LNK International | LNK International | Labeling Errors | Nationwide |
Other Diphenhydramine recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diphenhydramine 18mg in NS Syringe, antihistamine recalled | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | Diphenhydramine HCl Oral Solution, 25 mg / cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Diphenhydramine HCl Oral Solution 12.5 mg / cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Diphenhydramine HCl oral solution, USP, 25 mg/ UD recalledDiphenhydramine Hydrochloride | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Banophen Diphenhydramine HCl 25 mg Antihistamine recalledDiphenhydramine Hydrochloride | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |