HIGH

Cetirizine Hydrochloride Tablets Recall 2025 Over Wrong ID Imprint, 13,440 Bottles Nationwide

Rising Pharma Holdings, Inc. is recalling 13,440 bottles of Cetirizine Hydrochloride Tablets USP 10 mg distributed nationwide in the United States. The tablets are imprinted with the wrong ID. Stop using the product and contact the manufacturer or your healthcare provider for guidance.

Quick Facts at a Glance

Recall Date
September 12, 2025
Hazard Level
HIGH
Brands
Cetirizine Hydrochloride, Rising Pharma Holdings, Unique Pharmaceuticals Labs...
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT

Hazard Information

Tablet/Capsules Imprinted with Wrong ID

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact JB Chemicals and Pharmaceuticals Ltd or your healthcare provider for guidance. Notification method: Letter

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

About This Product

Cetirizine hydrochloride is a non-drowsy antihistamine used to treat allergy symptoms. This recall concerns mislabeled tablets rather than an active drug safety issue.

Why This Is Dangerous

Wrong ID imprinting can cause patients to take a different drug or dose, risking ineffective treatment or adverse reactions.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Consumers may experience dosing confusion or take the wrong product. No injuries reported to date, but the labeling error poses safety and accuracy concerns.

Practical Guidance

How to identify if yours is affected

  1. Verify NDC 16571-402-50 on the bottle label
  2. Check lot codes PY925014 or PY925013
  3. Confirm expiration date 01/31/2028
  4. Inspect the tablet imprint to ensure correct identification

Where to find product info

NDC and lot numbers are printed on the bottle label and outer packaging; expiration date is also listed on the bottle.

What timeline to expect

Recall processing and any refunds or replacements will follow the recall administrator's timeline; expect updates.

If the manufacturer is unresponsive

  • Escalate to FDA MedWatch with the recall number.
  • File a consumer complaint if the manufacturer is unresponsive.

How to prevent similar issues

  • Purchase from reputable pharmacies.
  • Always verify NDC, lot numbers, and expiration before taking any medication.
  • Keep both bottle and carton until you confirm recall actions.

Documentation advice

Keep the bottle, packaging, and recall notices. Save correspondence with the manufacturer for refund or replacement claims.

Product Details

Product: Cetirizine Hydrochloride Tablets USP 10 mg, 500 tablets per bottle. Manufacturer: Unique Pharmaceuticals Labs, a division of JB Chemicals & Pharmaceuticals, Ltd., Mumbai, India. Distributor: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC: 16571-402-50. Quantity: 13,440 bottles. Distribution: U.S. nationwide. Sold since: Unknown. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 13,440 bottles recalled nationwide
  • NDC 16571-402-50
  • Lot PY925014, PY925013
  • Expiration 01/31/2028
  • Manufacturer: Unique Pharmaceuticals Labs (JB Chemicals & Pharmaceuticals)
  • Distributor: Rising Pharma Holdings, Inc.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERALPREGNANT
Injury Types
OTHER

Product Details

Model Numbers
Lot # PY925014
PY925013
Exp. 1/31/2028
UPC Codes
16571-402
16571-402-10
16571-402-50
Affected States
ALL
Report Date
October 29, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
MEDIUM

AvKARE Recalls Rosuvastatin Tablets Due to Dissolution Issues

AvKARE recalled 7,991 cartons of Rosuvastatin Tablets on December 31, 2025. The recall stems from the product being out of specification for dissolution. Consumers should stop using the medication immediately and consult healthcare providers for guidance.

LACTATED RINGERS
Presence of
Read more
Recalled ZOLIQUEX Bed Rail (front view)
HIGH

ZOLIQUEX Adult Portable Bed Rails Recalled for Entrapment, Asphyxiation Risk (2026)

ZOLIQUEX recalled adult portable bed rails sold on Amazon after reports of entrapment and asphyxiation risk. The recall targets silver bed rails measuring 12.4 inches wide by 33.07 inches tall and weighing 7.1 pounds. The model numbers ZEX014-V1 and the Zoliquex branding appear on packaging. Stop using the product and seek a full refund by contacting ZOLIQUEX.

ZOLIQUEX, of China
The recalled
Read more
Recalled Arey, Not Today, Grey (180ct) - front
HIGH

Vitaquest International Recalls Multiple Iron Supplements for Child-Resistant Packaging Violations (

Vitaquest International recalled Arey Not Today iron supplements sold at retailers nationwide after determining the products do not meet the Poison Prevention Packaging Act's child-resistant packaging requirement. The noncompliant packaging creates a poisoning risk to young children if ingested. Consumers should stop using the products immediately and contact Vitaquest for a free child-resistant替换

Vitaquest International LLC of West Caldwell, New Jersey
The dietary
Read more
Recalled Easymake Bed Rail
HIGH

Easymake Adult Portable Bed Rails Recalled for Entrapment Risk (2026)

Easymake adult portable bed rails imported by ZFZG-US are recalled on April 9, 2026. The recall cites a risk of entrapment and asphyxiation and notes the product lacks required hazard warning labels. Stop using the recalled rails immediately and contact ZFZG-US for a full refund.

Zhongshan Yungu Daily Products, of China
The recalled
Read more
Recalled Tuymec Minoxidil Hair Growth Serum Spray Bottle (front and back)
HIGH

Tuymec Minoxidil Hair Growth Kit Recalled for Non-Child-Resistant Packaging (2026)

Tuymec Minoxidil Hair Growth Kit sold on Amazon by DrHealBeauty is recalled for non-child-resistant packaging. The kit contains two black spray bottles with 5% minoxidil and BIOTIN labels. Consumers should stop using the product immediately and contact DrHealBeauty for a free empty replacement bottle with a child-resistant closure.

Tuymec Minoxidil Hair Growth Spray Bottles
The hair
Read more
Recalled TecFlox Topical Solution - hair and beard growth serum bottle
HIGH

TecFlox Minoxidil Topical Solution Hair Serum Recalled for Child Poisoning Risk (2026)

TecFlox recalled its Minoxidil Topical Solution hair growth serum bottles on April 2, 2026. The packaging is not child-resistant, violating the Poison Prevention Packaging Act. Consumers should stop using the product immediately, store it out of reach of children, and email TecFloxrecall@outlook.com to receive free replacement bottles. Only bottles with serum remaining will be replaced; dispose of

TecFlox Hair and Beard Growth Serum Bottles
The hair
Read more