HIGH

Rising Pharma Recalls Cetirizine Hydrochloride Tablets Over Mislabeling

Rising Pharma Holdings recalled 13,440 bottles of Cetirizine Hydrochloride Tablets on September 12, 2025. The tablets are imprinted with incorrect identification. This recall affects consumers nationwide.

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

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Product Details

The recalled product is Cetirizine Hydrochloride Tablets USP 10 mg, packaged in 500-tablet bottles. Manufactured by Unique Pharmaceuticals Labs in Mumbai, India, it is distributed by Rising Pharma Holdings, Inc. The affected lot numbers are PY925014 and PY925013, with an expiration date of January 31, 2028.

The Hazard

The tablets are imprinted with the wrong identification, which poses a risk of incorrect medication being dispensed. This error can lead to serious health consequences for users.

Reported Incidents

No injuries or incidents have been reported due to the mislabeling as of the recall date. However, the potential for harm remains high.

What to Do

Consumers should stop using the product immediately. Contact JB Chemicals and Pharmaceuticals Ltd or your healthcare provider for guidance and possible return instructions.

Contact Information

For more information, consumers can visit the FDA website or contact Rising Pharma Holdings directly.

Key Facts

  • Recall date: September 12, 2025
  • Total quantity: 13,440 bottles
  • Lot numbers: PY925014, PY925013
  • Expiration date: January 31, 2028

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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 # 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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