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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/Prescription Drugs

Aidarex Pharmaceuticals LLC: Ferrous Sulfate 325 MG Tablets Recalled for Foreign Tablet Presence

Agency Publication Date: May 15, 2018
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Summary

Aidarex Pharmaceuticals LLC has recalled 450 bottles of Ferrous Sulfate 325 MG (iron supplement) tablets due to the presence of foreign tablets or capsules found inside the bottles. This recall specifically affects 100-count bottles distributed in Florida. Consumers should check their medicine cabinets for this iron supplement to ensure they do not accidentally consume an incorrect medication.

Risk

The presence of foreign tablets or capsules in a prescription or over-the-counter medication bottle poses a risk that a patient may ingest the wrong drug, which could lead to adverse health effects or ineffective treatment of their condition.

What You Should Do

  1. Check your medication bottle for Ferrous Sulfate 325 MG tablets with NDC 33261-0715-00.
  2. Verify the Batch ID and expiration date on the label: look for Batch ID 57909-1 (expiration 04/30/2019) or Batch ID 57909-2 (expiration 06/30/2019).
  3. Stop using the product immediately if it matches the identified batch numbers and check the contents for any tablets that appear different from the rest.
  4. Contact your healthcare provider or pharmacist for guidance regarding your iron supplement therapy.
  5. Return any unused product to the pharmacy or place of purchase for a refund and contact Aidarex Pharmaceuticals LLC 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

๐Ÿ’ฐFull 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: Ferrous Sulfate 325 MG tablet (450 bottles)
Model:
NDC 33261-0715-00
Lot Numbers:
57909-1 (Exp. 04/30/2019)
57909-2 (Exp. 06/30/2019)
Date Ranges: April 30, 2019, June 30, 2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79835
Status: Resolved
Manufacturer: Aidarex Pharmaceuticals LLC
Manufactured In: United States
Units Affected: 450 bottles
Distributed To: Florida

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.