Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only Recalled by AVKARE Inc. Due to CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API...
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 AVKARE Inc. directly.
Affected Products
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Quantity: 1351 bottles
Why Was This Recalled?
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Where Was This Sold?
This product was distributed to 2 states: CO, MO
About AVKARE Inc.
AVKARE Inc. has 33 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report