The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0206-2018·Announced 2018-01-17

FDA Recalls 7-Keto DHEA Capsules Due to Expired Ingredient

KRS Global Biotechnology is recalling 7-Keto DHEA 100 mg capsules because the product's expiration date exceeds the expiration date of at least one ingredient.

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: The recall is classified as FDA Class II, which the rubric associates with moderate severity, specifically involving labeling errors and low-risk contamination without reported injuries.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for 7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg capsules manufactured by KRS Global Biotechnology, Inc. The recall is limited to Lot 08012017@35, which has a Beyond Use Date (BUD) of January 28, 2018. The product is a prescription-only medication packaged in bottles of 90 capsules.

The recall was initiated due to a labeling and quality control issue where the Beyond Use Date (BUD) of the final product exceeds the expiration date of at least one ingredient used in its manufacture. This discrepancy indicates that the product may contain ingredients that were past their expiration date at the time the final product was labeled with its expiration date.

The affected capsules were distributed nationwide in the United States, as well as in Bermuda and New Zealand. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Manufacturer
KRS Global Biotechnology, Inc
Category
Drug — Prescription Capsules
Hazard
Affected units
90

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)

  • Lot: 08012017@35 BUD: 1/28/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 47 recalled by KRS Global Biotechnology, 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 47 products in this recall →

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