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Recall Observatory FDA recall evidence

Drug product

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

D-0033-2026

September 12, 2025

Class III

Product summary

Firm
JB Chemicals and Pharmaceuticals Ltd
Event
Event 97573
Status
Ongoing
Classification
Class III
Quantity
13,440 bottles
Official record key
drug-enforcement:D-0033-2026

Official wording

Reason: Tablet/Capsules Imprinted with Wrong ID

Code information: Lot # PY925014, PY925013, Exp. 1/31/2028

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Tablet/Capsules Imprinted with Wrong ID