The Recall Desk
ModerateFDA (Drugs)·D-0502-2021·Announced 2021-06-02

Cardinal Health Recalls Phentermine HCL Capsules Due to Temperature Excursions

Cardinal Health Inc. is recalling 237 bottles of Phentermine HCL 37.5mg capsules due to intermittent temperature exposure during storage.

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: The recall is classified as FDA Class II due to a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cardinal Health Inc. is recalling 237 bottles of Phentermine HCL 37.5mg capsules (NDC 10702002901, Lot 16649A). The recall was initiated because the product experienced intermittent exposure to temperature excursions during storage, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.

The affected product was distributed in Florida, Georgia, and South Carolina. The source text does not specify the exact dates of distribution or the specific retail locations where the product was sold.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
PHENTERMINE HCL 37.5MG 100 C4; NDC/UPC 10702002901; RX; CAPSULES
Manufacturer
Cardinal Health Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
237

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)

  • 16649A

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health 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 198 products in this recall →

Related recalls

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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