Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Meclizine Hydrochloride Tablets Recalled by Par Pharmaceutical Inc. Due to Failed Impurities/Degradation Specifications: Out of specification for impurities.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Par Pharmaceutical Inc. directly.
Affected Products
Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Quantity: a) 162,385 Bottles; b) 6949 Bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Par Pharmaceutical Inc.
Par Pharmaceutical Inc. has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report