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.

Acetaminophen Oral Suspension Recalled by Precision Dose Inc. Due to cGMP Deviations: Product manufactured with contaminated raw ingredient.

Date: November 1, 2021
Company: Precision Dose Inc.
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 Precision Dose Inc. directly.

Affected Products

Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.

Quantity: 166,920 unit dose cups

Why Was This Recalled?

cGMP Deviations: Product manufactured with contaminated raw ingredient.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Precision Dose Inc.

Precision Dose Inc. has 7 total recalls tracked by RecallDetector.

Related Recalls

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