Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, 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 16571-402-50
Reported: October 29, 2025 Initiated: September 12, 2025 #D-0033-2026
Product Description
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, 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 16571-402-50
Reason for Recall
Tablet/Capsules Imprinted with Wrong ID
Details
- Recalling Firm
- JB Chemicals and Pharmaceuticals Ltd
- Units Affected
- 13,440 bottles
- Distribution
- U.S. Nationwide
- Location
- Mumbai
Frequently Asked Questions
What product was recalled? ▼
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, 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 16571-402-50. Recalled by JB Chemicals and Pharmaceuticals Ltd. Units affected: 13,440 bottles.
Why was this product recalled? ▼
Tablet/Capsules Imprinted with Wrong ID
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 29, 2025. Severity: Low. Recall number: D-0033-2026.
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