Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Wockhardt Promethazine and Valproic Acid Recalled for Microbial Contamination

Agency Publication Date: September 20, 2021
Share:
Sign in to monitor this recall

Summary

Morton Grove Pharmaceuticals and Wockhardt USA are recalling 170,052 bottles of Promethazine Syrup, Promethazine with Codeine, and Valproic Acid Oral Solution. These prescription medications, used for treating allergies, coughs, and seizures, may have been manufactured using liquid sugar batches contaminated with microbial organisms. No illnesses or injuries have been reported to date regarding this recall.

Risk

Consumption of products contaminated with microorganisms can lead to serious infections, particularly in patients with compromised immune systems. The contamination occurred due to deviations in manufacturing processes involving the liquid sugar ingredient.

What You Should Do

  1. The recalled products include 1-pint (473 mL) bottles of Promethazine Syrup (NDC 60432-608-16), Promethazine with Codeine (NDC 60432-606-16), and Valproic Acid (NDC 60432-621-16) manufactured for Wockhardt USA, LLC.
  2. Identify if your product is affected by checking the lot numbers on the label: Promethazine Syrup lots UV1335, UV1352, or UV1373; Promethazine with Codeine lot UV1198; or Valproic Acid lot UV1159.
  3. If you have health concerns or are currently taking these medications, contact your healthcare provider or pharmacist immediately.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact Wockhardt USA, LLC for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this safety alert.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Promethazine Syrup Plain, 6.25 mg/5 mL (473 mL)by Wockhardt
Variants: Syrup, 6.25 mg/5 mL
Lot Numbers:
UV1335
UV1352
UV1373
NDC:
60432-608-16

Manufactured for Wockhardt USA, LLC.

Product: Promethazine With Codeine Oral Solution (473 mL)by Wockhardt
Variants: Oral Solution, 6.25 mg/5mL & 10 mg/5 mL
Lot Numbers:
UV1198
NDC:
60432-606-16

Manufactured for Wockhardt USA, LLC.

Product: Valproic Acid Oral Solution USP (473 mL)by Wockhardt
Variants: Oral Solution, 250 mg/5 mL
Lot Numbers:
UV1159
NDC:
60432-621-16

Manufactured for Wockhardt USA, LLC.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88629
Status: Resolved
Manufacturer: Morton Grove Pharmaceuticals, Inc.
Sold By: Wockhardt USA, LLC
Manufactured In: United States
Units Affected: 3 products (116,400 bottles; 14,904 bottles; 38,748 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.