The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0810-2018·Announced 2018-05-23

Aidarex Recalls Ferrous Sulfate Tablets Due to Foreign Material Presence

Aidarex Pharmaceuticals LLC is recalling 450 bottles of Ferrous Sulfate 325 MG tablets distributed in Florida because foreign tablets or capsules were found in the product.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor or theoretical risks.

Plain-English summary

Aidarex Pharmaceuticals LLC is recalling 450 bottles of Ferrous Sulfate 325 MG tablets (NDC 33261-0715-00) due to the presence of foreign tablets or capsules. The affected product was distributed to Florida. The recall includes two specific batch IDs: 57909-1 with an expiration date of 04/30/2019, and 57909-2 with an expiration date of 06/30/2019.

The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. The primary hazard identified is the physical presence of foreign tablets or capsules within the product packaging.

Consumers who have purchased this product should check their inventory for the specific NDC and batch IDs listed above. If the product matches the recalled description, consumers should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal.

The recalled product

Product
Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00
Manufacturer
Aidarex Pharmaceuticals LLC
Category
Drug — Oral Solid Dosage
Hazard
Affected units
450

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • NDC 33261-0715-00 Batch ID: 57909-1
  • exp. date 04/30/2019 57909-2
  • exp. date 06/30/2019

Distribution

Distributed in 1 state:

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