The Recall Desk
ModerateFDA (Drugs)·D-0855-2023·Announced 2023-06-07

Vitamin D Supplement Drops Recalled Due to Manufacturing Practice Violations

Akorn, Inc. is recalling Vitamin D Supplement Drops (400 IU, Cherry Flavored, 50mL) distributed nationwide because the firm ceased operations and could not complete required stability studies.

What this means for you

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 an FDA Class II recall driven by CGMP deviations and the firm's inability to complete required stability studies due to business closure. No illnesses, injuries, or adverse effects have been reported, making this a precautionary manufacturing compliance issue.

Plain-English summary

Akorn, Inc. is recalling all lots of Vitamin D Supplement Drops, 400 IU, Cherry Flavored, 50mL bottles, distributed nationwide in the USA and Puerto Rico.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. The recalling firm ceased business operations and was unable to complete the stability studies required to verify that the product maintains its labeled potency and safety throughout its intended shelf life. Stability studies are critical for ensuring that supplement products remain safe and effective during storage.

Consumers who have purchased this product should not use it. Consult with a healthcare provider if you have questions about your vitamin D supplementation needs. Healthcare providers and consumers should report any adverse effects associated with this product to the FDA's MedWatch program.

The recalled product

Product
Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Supplement / Vitamin
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 →

Related recalls

Same manufacturer · Akorn, Inc.

See all →

Same hazard · cgmp deviation

See all →