Cetirizine Hydrochloride Tablet
FDA Recall NDC 16571-402
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Cetirizine Hydrochloride (NDC 16571-402). A significant event, classified as Class III, was initiated on Sep 12, 2025 by Rising Pharma Holdings, Inc.. The reported reason for this action was: "Tablet/Capsules Imprinted with Wrong ID"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Tablet/Capsules Imprinted with Wrong ID
Sep 12, 2025
Oct 29, 2025
9936 bottles
Recall Profile & Regulatory Data
Event ID
97573
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
JB Chemicals and Pharmaceuticals Ltd
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Cetirizine Hydrochloride Tablets USP 10 mg, 100 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 16571-402-10.
Batch or Lot Expiration Information
Lot# PY925014A; Exp. 1/31/2028
Affected Packages Involved in this Recall
16571-402-10Product
16571-402-30Product
16571-402-50Product
Class III Ongoing
Tablet/Capsules Imprinted with Wrong ID
Sep 12, 2025
Oct 29, 2025
13,440 bottles
Recall Profile & Regulatory Data
Event ID
97573
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
JB Chemicals and Pharmaceuticals Ltd
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
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
Batch or Lot Expiration Information
Lot# PY925014, PY925013, Exp. 1/31/2028
Affected Packages Involved in this Recall
16571-402-10Product
16571-402-30Product
16571-402-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
