Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Clonidine Hydrochloride Tablets Recalled by Mutual Pharmaceutical Company, Inc. Due to cGMP Deviations; Clonidine hydrochloride drug substance used in...
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 Mutual Pharmaceutical Company, Inc. directly.
Affected Products
Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA
Quantity: a) 96,640 bottles; b) 17,808 bottles
Why Was This Recalled?
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Where Was This Sold?
Nartionwide
About Mutual Pharmaceutical Company, Inc.
Mutual Pharmaceutical Company, Inc. has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report