Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.
USCetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.
Recalling Firm: JB Chemicals and Pharmaceuticals Ltd
Reason for Recall / Hazard
TranslatedCross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Product Description & Identification
TranslatedCetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.
Additional Source Details
| Field | Value |
|---|---|
| City | Mumbai |
| State | N/A |
| Openfda › Unii | 64O047KTOA |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 1014676 |
| Openfda › Spl id | 37fb3dd8-d5bf-46e4-8331-0c8c1eac540d |
| Openfda › Brand name | CETIRIZINE HYDROCHLORIDE |
| Openfda › Spl set id | 6493d4f6-dead-45ec-ade1-28ce624af33d |
| Openfda › Package ndc | 16571-401-10 |
| Openfda › Product ndc | 16571-401 |
| Openfda › Generic name | CETIRIZINE HYDROCHLORIDE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name | CETIRIZINE HYDROCHLORIDE |
| Openfda › Manufacturer name | Rising Pharma Holdings, Inc. |
| Openfda › Application number | ANDA077829 |
| Openfda › Is original packager | true |
| Event id | 99321 |
| Address 1 | Neelam Centre A Wing A B Wing |
| Address 2 | 4th Floor; Hind Cycle Road |
| Code info | Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT |
| Postal code | N/A |
| Report date | 20260729 |
| Product type | Drugs |
| Product quantity | 34,020 100-count bottles. |
| Reason for recall | Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260624 |
| Initial firm notification | Letter |
| Center classification date | 20260803 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Overview
- Recalling FirmJB Chemicals and Pharmaceuticals Ltd
- StatusOngoing
- Risk LevelClass I
- DistributionNationwide in the USA
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🚨 SAFETY ALERT: JB Chemicals and Pharmaceuticals Ltd - Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10. Check if your household is affected: https://therecallfile.com/recalls/cetirizine-hydrochloride-tablets-usp-5-mg-100-count-bottle-manufacture/FDA-D-0732-2026
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