Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Maximum Strength Acid Reducer Recalled by Perrigo Company PLC Due to CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

Date: October 23, 2019
Company: Perrigo Company PLC
Status: Terminated
Source: FDA (Drug)

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 Perrigo Company PLC directly.

Affected Products

Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75

Why Was This Recalled?

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Perrigo Company PLC

Perrigo Company PLC has 106 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report