HIGH

Unique Pharmaceuticals Cetirizine Hydrochloride 10 mg Tablets Recalled Nationwide in 2025

9,936 bottles of Cetirizine Hydrochloride Tablets USP 10 mg were recalled nationwide in the United States. Manufactured by Unique Pharmaceuticals Labs and distributed by Rising Pharma Holdings, the lot carries imprint with the wrong ID. Stop using the product immediately 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
INFANTS, CHILDREN, ELDERLY

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

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About This Product

Cetirizine hydrochloride is an OTC antihistamine used to relieve allergy symptoms. This recall involves a packaging/identification error on 10 mg tablets.

Why This Is Dangerous

Wrong imprint ID can lead to misidentification and dosing errors, potentially resulting in inappropriate use.

Industry Context

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

Real-World Impact

The recall affects consumers nationwide who may possess mislabeled cetirizine tablets, creating risk of dosing mistakes and confusion.

Practical Guidance

How to identify if yours is affected

  1. Review bottle label for lot PY925014A and expiration 2028-01-31
  2. Verify NDC 16571-402-10
  3. Compare imprint details with recall notice

Where to find product info

Recall page and details at the FDA enforcement site linked in the article and/or the enforce_rpt recall page provided above.

What timeline to expect

Not specified in the recall notice

If the manufacturer is unresponsive

  • Contact JB Chemicals & Pharmaceuticals Ltd for guidance
  • Contact Rising Pharma Holdings, Inc. for additional information
  • File a complaint with the FDA if needed

How to prevent similar issues

  • Always verify imprint, NDC, lot number, and expiration date before taking any medication
  • Buy from reputable pharmacies and check packaging for consistency with the labeling
  • Be cautious of imprint changes and report suspicious products to manufacturer or regulator
  • Maintain a copy of the recall notice for future reference

Documentation advice

Keep the bottle packaging, recall notice, purchase records, and any correspondence with the manufacturer or distributor

Product Details

Brand: Cetirizine Hydrochloride. Manufacturer: Unique Pharmaceuticals Labs, a division of J.B. Chemicals & Pharmaceuticals Ltd., Mumbai, India. Distributor: Rising Pharma Holdings, Inc., East Brunswick, NJ. NDC: 16571-402-10. Lot: PY925014A. Expiration: 2028-01-31. Bottles recalled: 9,936. Sold/distributed: U.S. nationwide. Country of origin: India. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 9,936 bottles recalled
  • NDC 16571-402-10
  • Lot PY925014A
  • Exp 2028-01-31
  • Manufacturer: Unique Pharmaceuticals Labs (A Div. of JB Chemicals & Pharmaceuticals Ltd.)
  • Distributor: Rising Pharma Holdings, Inc., East Brunswick, NJ United States nationwide

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

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
INFANTSCHILDRENELDERLYPREGNANTPETS
Injury Types
POISONINGLACERATIONOTHER

Product Details

Model Numbers
PY925014A
2028-01-31
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

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