Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Promethazine With Codeine Oral Solution Recalled by Morton Grove Pharmaceuticals, Inc. Due to CGMP Deviations: Potential concern with products manufactured using...
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 With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 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: 60432-606-16
Quantity: 14,904 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.
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