Rising Pharma Cetirizine 5 mg Tablets Recalled Over Potential Ranitidine Contamination
Urgent consumer alert: four lots of Rising Pharma Cetirizine Hydrochloride 5 mg tablets are being recalled nationwide after quality-control testing detected possible cross-contamination with ranitidine. Individuals who are hypersensitive to ranitidine could experience severe—and potentially life-threatening—allergic reactions. Stop using the affected tablets immediately and follow the FDA’s disposal or return guidance below.
Key Recall Details: Rising Pharma Cetirizine 5 mg
- Recalled Product: Cetirizine Hydrochloride Tablets USP 5 mg (100-count HDPE bottles)
- NDC: 16571-401-10
- Brand / Distributor: Rising Pharma Holdings Inc.
- Manufacturer: Unique Pharmaceutical Laboratories (Division of J. B. Chemicals & Pharmaceuticals Ltd.)
- Recall Initiated: 18 July 2026 (FDA posting 20 July 2026)
- Reason: Suspected ranitidine cross-contamination; risk of severe hypersensitivity or anaphylaxis
- Distribution: Nationwide (U.S.) to wholesalers and retail pharmacies
Sources
Affected Lot Numbers & Expiry Dates
- GY825029 – Expires 10/2028
- GY825030 – Expires 10/2028
- GY825031 – Expires 10/2028
- GY825032 – Expires 10/2028
Why Ranitidine Contamination Is Dangerous
Even trace amounts of ranitidine can provoke severe hypersensitivity reactions in allergic patients, including:
- Sudden drop in blood pressure (hypotension)
- Breathing difficulty (dyspnea or bronchospasm)
- Swelling of the throat, tongue, or face (angioedema)
- Hives, rash, or intense itching
- Loss of consciousness or full anaphylaxis
No adverse events have been reported to date. Nonetheless, the FDA advises consumers to discontinue use of the recalled lots as a precaution.
What Consumers Should Do
- Check the lot number printed on the bottle label.
- If it corresponds to one of the four lots above, immediately stop taking the tablets.
- Return the product to the pharmacy/retailer or follow Rising Pharma’s return instructions for a refund or replacement.
- If return is impossible, dispose of the tablets following FDA drug-disposal guidelines.
- Contact a healthcare professional if you experience any reaction or have medical questions.
Contact Information & Adverse-Event Reporting
Rising Pharma Holdings Inc.
Phone: 1-844-874-7464 (Mon–Fri, 8 a.m.–5 p.m. EST)
Email: pv@risingpharma.com / qa@risingpharma.com
Report side effects to the FDA MedWatch program:
Online: fda.gov/medwatch
Phone: 1-800-332-1088
Official Recall Images
Rising Pharma Cetirizine Recall FAQ
- 1. Which Rising Pharma Cetirizine 5 mg lots are under recall?
- Lots GY825029, GY825030, GY825031, and GY825032, all expiring in October 2028, are affected.
- 2. Why did Rising Pharma Cetirizine test positive for ranitidine contamination?
- Internal quality testing suggested cross-contamination during manufacturing, prompting a voluntary recall to protect consumers with ranitidine allergies.
- 3. Is it safe to keep using other Rising Pharma Cetirizine strengths or lots?
- Yes. Only the four listed 5 mg lots are impacted; no other strengths or lot numbers are involved at this time.
- 4. How do I obtain a refund for my recalled Rising Pharma Cetirizine bottle?
- Call Rising Pharma’s customer-service line at 1-844-874-7464 or email pv@risingpharma.com / qa@risingpharma.com for prepaid return labels and refund details.
- 5. What should I do if I already took the recalled Rising Pharma Cetirizine tablets?
- If you develop symptoms such as rash, swelling, or breathing difficulty, seek emergency medical attention and inform your healthcare provider about the recall.
- 6. How can healthcare professionals report problems related to Rising Pharma Cetirizine?
- Clinicians should submit adverse-event reports through the FDA MedWatch portal or by calling 1-800-332-1088.