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

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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

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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

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