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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Cetirizine Hydrochloride, Rising Pharma Holdings, Unique Pharmaceuticals Labs, JB Chemicals & Pharmaceuticals Ltd
- Product type
- Cetirizine Hydrochloride Tablets 10 mg
- Model numbers
- PY925014A, 2028-01-31
- UPC codes
- 16571-402, 16571-402-10, 16571-402-50
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 12, 2025
Reported by FDA DRUG
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Review bottle label for lot PY925014A and expiration 2028-01-31
- 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
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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
- Lot PY925014A
- Manufacturer: Unique Pharmaceuticals Labs (A Div. of JB Chemicals & Pharmaceuticals Ltd.)
- Distributor: Rising Pharma Holdings, Inc., East Brunswick, NJ United States nationwide
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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