Nationwide recall of prescription doxycycline hyclate tablets due to manufacturing temperature deviations
McKesson is recalling doxycycline hyclate 100 mg tablets nationwide due to temperature abuse during manufacturing that fails to meet good manufacturing practice standards.
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: FDA Class II recall with no reported illnesses or injuries. The hazard stems from manufacturing process deviations (temperature abuse) that could affect product potency; no acute safety threat has been documented.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling doxycycline hyclate 100 mg tablets, a prescription antibiotic. The recall affects 108 cartons of 50-count packaging that were distributed throughout the United States.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations during manufacturing, specifically temperature abuse. Temperature exposure during the manufacturing process may compromise the drug's potency and stability.
Patients taking doxycycline from the recalled lots should contact their healthcare provider or pharmacist for guidance on their medication. Do not discontinue antibiotic treatment without medical advice, as doxycycline is often prescribed to treat serious infections.
The recalled product
- Product
- DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
- Brand
- DOXYCYCLINE HYCLATE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Prescription Antibiotic
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
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