Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ranitidine Oral Solution Recalled by Precision Dose 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 Precision Dose Inc. directly.
Affected Products
Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080
Quantity: 224,940 unit dose cups
Why Was This Recalled?
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Precision Dose Inc.
Precision Dose Inc. has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report