The Recall Desk
ModerateFDA (Drugs)·D-1032-2022·Announced 2022-06-15

Doxycycline Capsules Recalled for Temperature Control Deviation

McKesson Medical-Surgical is recalling Doxycycline Capsules, USP, 100 mg due to temperature abuse during manufacturing. The Class II recall affects 3 bottles distributed nationwide across the USA.

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 a Class II recall due to a manufacturing control deviation with no reported illnesses or injuries cited in the source. Per the severity rubric, Class II recalls without hospitalization reports score at most Moderate (2). The hazard is a manufacturing practice violation with potential but unconfirmed impact.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling Doxycycline Capsules, USP, 100 mg in 50-count bottles (NDC 63304-616-50), distributed by Sun Pharmaceuticals. Approximately 3 bottles were affected and distributed nationwide across the USA.

The recall was issued due to a cGMP deviation: temperature abuse during manufacturing. Temperature control is essential for maintaining pharmaceutical product stability and efficacy.

Healthcare providers and pharmacists who have received affected product should verify their inventory using the distribution dates provided by McKesson. Patients currently taking this medication should contact their healthcare provider or pharmacist for guidance. The recalling firm is notifying all known consignees and will provide detailed lot number information to assist with recall completion.

The recalled product

Product
DOXYCYCLINE (DOXYCYCLINE)
Brand
DOXYCYCLINE
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Prescription Antibiotic
Hazard
Affected units
3

Is your product affected?

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

UPCs (1)

  • 0363304614015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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 130 products in this recall →

Related recalls

Same brand · DOXYCYCLINE

Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office

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Same hazard · temperature abuse

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