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

Levsin Injection Recalled for Manufacturing Quality Control Issues

Agency Publication Date: June 5, 2023
Share:
Sign in to monitor this recall

Summary

Viatris Inc. (distributed by Meda Pharmaceuticals) is recalling 2,736 boxes of Levsin (hyoscyamine sulfate) injection. The recall was issued because the manufacturer discontinued a quality control program intended to ensure the drug meets standards for identity, strength, quality, and purity. This medication is used for various gastrointestinal and medical conditions, and this specific recall affects 0.5 mg per ml ampules in boxes of five. No incidents or injuries have been reported to date.

Risk

Because the quality control program was discontinued, the manufacturer cannot guarantee the injection contains the correct strength or purity of the active ingredient. Poor quality control in injectable medications can lead to ineffective treatment or potential contamination, though no specific adverse reactions have been reported.

What You Should Do

  1. This recall affects Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml, packaged in boxes of five 1 ml ampules under NDC 0037-9001-05.
  2. Check your medication for lot number 101241A with an expiration date of October 2023 (10/23).
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

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: Levsin injection (hyoscyamine sulfate injection, USP) (Box of 5 ampules)
Variants: 0.5 mg per ml, 1 ml Ampule
Lot Numbers:
101241A (Exp 10/23)
NDC:
0037-9001-05

Distributed by Meda Pharmaceuticals Inc. (a Viatris company).

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92366
Status: Resolved
Manufacturer: Viatris Inc
Sold By: distributors; retail pharmacies
Manufactured In: United States
Units Affected: 2,736 boxes
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.