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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Cetirizine Hydrochloride Tablets Recalled for Incorrect ID Imprint

Agency Publication Date: October 17, 2025
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Summary

JB Chemicals and Pharmaceuticals Ltd is recalling approximately 23,376 bottles of Cetirizine Hydrochloride Tablets USP (10 mg) because the tablets or capsules were imprinted with the wrong identification codes. This recall affects both 100-count and 500-count bottles manufactured in India and distributed across the United States. While the medication itself is the correct strength and generic type, the incorrect marking could lead to identification errors for patients and healthcare providers.

Risk

The tablets contain the correct medication, but the incorrect identification imprint can lead to confusion, potentially causing patients to take the wrong medication or doubt their treatment regimen.

What You Should Do

  1. Check your medication bottle for Cetirizine Hydrochloride Tablets USP 10 mg with NDC 16571-402-10 (100-count) or NDC 16571-402-50 (500-count).
  2. Look for lot number PY925014A with expiration date 1/31/2028 on 100-count bottles.
  3. Look for lot numbers PY925014 or PY925013 with expiration date 1/31/2028 on 500-count bottles.
  4. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cetirizine Hydrochloride Tablets USP 10 mg (100 Tablets bottles)by Rising Pharma Holdings, Inc.
Variants: 10 mg, Tablets
Lot Numbers:
PY925014A (Exp. 1/31/2028)
NDC:
16571-402-10

Manufactured by Unique Pharmaceuticals Labs (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.)

Product: Cetirizine Hydrochloride Tablets USP 10 mg (500 Tablets bottles)by Rising Pharma Holdings, Inc.
Variants: 10 mg, Tablets
Lot Numbers:
PY925014 (Exp. 1/31/2028)
PY925013 (Exp. 1/31/2028)
NDC:
16571-402-50

Manufactured by Unique Pharmaceuticals Labs (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97573
Status: Active
Manufacturer: JB Chemicals and Pharmaceuticals Ltd
Sold By: Rising Pharma Holdings, Inc.
Manufactured In: India
Units Affected: 2 products (9936 bottles; 13,440 bottles)
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.