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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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Low RiskFDA Drug
Medications & Supplements/Over-the-Counter

Sun Pharmaceutical Industries, Inc.: Loperamide Anti-Diarrheal Caplets Recalled Due to Misleading Package Labeling

Agency Publication Date: January 22, 2019
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Summary

Sun Pharmaceutical Industries, Inc. is recalling 5,040 cartons of Loperamide Hydrochloride Tablets USP (2 mg), an over-the-counter anti-diarrheal medication. This recall was initiated because the packaging contains conflicting information: the front panel correctly states the carton contains 24 caplets, but the side panel incorrectly lists 12 caplets. These products were sold under the Drug Mart-Food Fair brand in Ohio. Consumers who purchased this medication should check their packaging to ensure they are aware of the correct quantity and consult a healthcare professional regarding its use.

Risk

The labeling error creates confusion regarding the total amount of medication in the package, which could lead to incorrect usage or dosing expectations for the consumer.

What You Should Do

  1. Check your medicine cabinet for 'Loperamide Hydrochloride Tablets USP, 2 mg, Anti-Diarrheal' distributed by Drug Mart-Food Fair in 24-count cartons.
  2. Verify the package identifiers: look for UPC 0 93351 11270 6, NDC 53943-123-24, and Lot number 2979325 with an expiration date of 5/5021.
  3. Compare the front and side panels of the carton; if the front says '24 caplets' and the side says '12 caplets', your product is affected by this recall.
  4. Contact your healthcare provider or pharmacist for guidance regarding the use of this medication.
  5. Return any unused product to the pharmacy or place of purchase for a refund and contact Sun Pharmaceutical Industries at 1-888-723-3332 for further instructions.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

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

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

Affected Products

Product: Loperamide Hydrochloride Tablets USP, 2 mg, Anti-Diarrheal (24 caplets per carton)
Model:
NDC 53943-123-24
UPC Codes:
093351112706
Lot Numbers:
2979325 (Exp 5/5021)
Date Ranges: Expiration 5/5021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81893
Status: Resolved
Manufacturer: Sun Pharmaceutical Industries, Inc.
Sold By: Drug Mart-Food Fair
Manufactured In: United States
Units Affected: 5040 cartons
Distributed To: Ohio
Agency Last Updated: January 23, 2019

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 · 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.