HIGH

Unique Pharmaceuticals Recalls Cetirizine Tablets Over Wrong ID Imprint

Unique Pharmaceuticals Labs recalled 9,936 bottles of Cetirizine Hydrochloride Tablets on September 12, 2025. The tablets were imprinted with the wrong ID, posing a potential health risk. Consumers should stop using the product immediately and seek guidance from healthcare providers.

Quick Facts at a Glance

Recall Date
September 12, 2025
Hazard Level
HIGH
Brands
CETIRIZINE HYDROCHLORIDE, Rising Pharma Holdings, Inc.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

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

Product Details

The recall involves Cetirizine Hydrochloride Tablets USP 10 mg, sold in 100-tablet bottles. The lot number is PY925014A and the expiration date is January 31, 2028.

The Hazard

The tablets have an incorrect imprint, which can lead to confusion and improper use. This recall falls under Class III, indicating a potential risk but not likely to cause serious health consequences.

Reported Incidents

No specific injuries or incidents have been reported in connection with this recall. The risk remains high due to the potential for consumer confusion.

What to Do

Consumers should stop using the recalled tablets immediately. Contact JB Chemicals and Pharmaceuticals Ltd or your healthcare provider for further guidance.

Contact Information

For more information, consumers can visit the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0032-2026.

Key Facts

  • Recall date: September 12, 2025
  • Quantity recalled: 9,936 bottles
  • Lot number: PY925014A
  • Expiration date: January 31, 2028
  • Distributed nationwide in the U.S.

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeCetirizine Hydrochloride Tablets
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot # PY925014A
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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