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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.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Lohxa LLC: Bismuth Subsalicylate and Phenobarbital Recalled for Incorrect Expiration Dates

Agency Publication Date: April 10, 2019
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Summary

Lohxa LLC is recalling approximately 51 boxes (totaling 1,630 unit dose cups) of Bismuth Subsalicylate and Phenobarbital oral solutions. Bismuth Subsalicylate 262mg/15mL (generic Pepto-Bismol) and Phenobarbital 20 mg/5mL are included in this recall because the packaging labels show incorrect expiration dates. These medications were distributed to Massachusetts, New York, and Wyoming. Because the labeling is inaccurate, patients may inadvertently use the medicine past its safe and effective shelf life, which is particularly concerning for medications used to manage chronic conditions. Consumers should consult with a healthcare professional regarding the safety and effectiveness of their current supply.

Risk

Incorrect expiration dates can lead to the use of degraded or ineffective medication. For Phenobarbital, which is used to control seizures, reduced potency could result in a lack of seizure control, posing a significant health risk to the patient.

What You Should Do

  1. Check your medication to see if it matches Bismuth Subsalicylate Oral Suspension 262mg/15mL, NDC 70166-059-01, with lot number M030042P (Exp. 01/2020).
  2. Check your medication to see if it matches Phenobarbital Oral Solution, USP 20 mg/5mL, NDC 70166-536-02, with lot numbers M12031 (Exp. 12/2019) or T01241 (Exp. 02/2020).
  3. Contact your healthcare provider or pharmacist immediately to discuss whether your medication is still safe to use and to arrange for a replacement if necessary.
  4. Return any unused unit dose cups to the pharmacy where you received them for a full refund or proper disposal.
  5. Contact Lohxa LLC directly at their Worcester, MA office for more information regarding this voluntary recall.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Consumers should return the affected products to their place of purchase or pharmacy for a refund and speak with a medical professional about replacement medication.

Affected Products

Product: Bismuth Subsalicylate Oral Suspension 262mg/15mL (250 unit dose cups)
Model:
NDC 70166-059-01
Lot Numbers:
M030042P (Exp. 01/2020)
Date Ranges: 01/2020
Product: Phenobarbital Oral Solution, USP 20 mg/5mL (1380 unit dose cups)
Model:
NDC 70166-536-02
Lot Numbers:
M12031 (Exp. 12/2019)
T01241 (Exp. 02/2020)
Date Ranges: 12/2019, 02/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82538
Status: Resolved
Manufacturer: Lohxa LLC
Manufactured In: United States
Units Affected: 2 products (5 boxes - 250 unit dose cups.; 46 boxes - 1380 unit dose cups)
Distributed To: Massachusetts, New York, Wyoming
Agency Last Updated: April 15, 2019

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.