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.

Promethazine Syrup Plain Recalled by Morton Grove Pharmaceuticals, Inc. Due to CGMP Deviations: Potential concern with products manufactured using...

Date: September 3, 2021
Company: Morton Grove Pharmaceuticals, Inc.
Status: Completed
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 Morton Grove Pharmaceuticals, Inc. directly.

Affected Products

Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16

Quantity: 116,400 bottles

Why Was This Recalled?

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Morton Grove Pharmaceuticals, Inc.

Morton Grove Pharmaceuticals, Inc. has 9 total recalls tracked by RecallDetector.

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