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.

RPC APAP Elixir (Acetaminophen 160mg) Recalled by RIJ Pharmaceutical LLC Due to CGMP Deviations: Products are being recalled due to...

Date: May 7, 2018
Company: RIJ Pharmaceutical LLC
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 RIJ Pharmaceutical LLC directly.

Affected Products

RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY, NDC 53807-129-16, UPC 353807129161

Quantity: 228 bottles

Why Was This Recalled?

CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About RIJ Pharmaceutical LLC

RIJ Pharmaceutical LLC has 12 total recalls tracked by RecallDetector.

Related Recalls

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