The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0803-2023·Announced 2023-06-07

Ferrous Sulfate Iron Supplement Drops Recalled for Manufacturing Stability Issues

All lots of Ferrous Sulfate Iron Supplement Drops are being recalled nationwide. The manufacturer went out of business and cannot complete required stability studies to verify product safety.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a precautionary recall due to incomplete manufacturing stability studies caused by firm closure. While FDA classified this as Class II, no illnesses or injuries have been reported, and the hazard remains theoretical pending completion of safety verification studies.

Plain-English summary

Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles and distributed nationwide in the USA and Puerto Rico, are being recalled. The product is manufactured by Akorn, Inc., and all lots are affected.

The recall was issued because the manufacturer went out of business and can no longer continue the stability studies required by FDA regulations. These studies are essential to verify that the product maintains its quality and potency throughout its shelf life.

Consumers who have purchased this product should stop using it and consult with a healthcare provider or pharmacist about alternative iron supplements. Those with questions about the recall should contact the FDA or a healthcare professional.

The recalled product

Product
Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Supplement / Iron
Hazard

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 (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

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