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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: UV1335; UV1352; and UV1373
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Morton Grove Pharmaceuticals, Inc.
Reason for Recall:
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
completed

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lot #: UV1335; UV1352; and UV1373

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0814-2021

Related Recalls

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

Sep 3, 2021 Prescription Drugs Nationwide View Details →