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
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
- Product type
- Cetirizine Hydrochloride Tablets 10 mg
- Model numbers
- Lot # PY925014, PY925013, Exp. 1/31/2028
- UPC codes
- 16571-402, 16571-402-10, 16571-402-50
- Sizes
- 500 tablets per bottle
- 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 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
- Verify NDC 16571-402-50 on the bottle label
- Check lot codes PY925014 or PY925013
- Confirm expiration date 01/31/2028
- 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.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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
- Lot PY925014, PY925013
- Manufacturer: Unique Pharmaceuticals Labs (JB Chemicals & Pharmaceuticals)
- Distributor: Rising Pharma Holdings, Inc.
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
