The Recall Desk
HighFDA (Drugs)·D-1025-2022·Announced 2022-06-15

Amoxicillin capsules recalled due to temperature exposure during manufacturing

McKesson Medical-Surgical is recalling Amoxicillin 500mg capsules distributed nationwide due to temperature abuse during manufacturing that may compromise product potency and effectiveness.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of prescription antibiotic with manufacturing defect (temperature abuse causing cGMP deviation). No illnesses, injuries, or deaths reported. Classified as High severity under the rubric as a risk-of-harm product (reduced antibiotic potency) where injury has not yet been reported.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling Amoxicillin Capsules, USP 500mg (100-count bottles, Rx only) due to temperature abuse during the manufacturing process, which constitutes a deviation from current Good Manufacturing Practice (cGMP) standards. The product was manufactured by Sandoz Pharma and distributed nationwide by McKesson Medical-Surgical. The recall involves 12 bottles distributed to customers. No illnesses or injuries have been reported to date in connection with this recall.

Temperature abuse during manufacturing may compromise the potency and effectiveness of the antibiotic. Patients who have received affected product should consult with their healthcare provider or pharmacist before taking any action regarding their current medication. Customers who received this product are asked to contact McKesson Medical-Surgical or their healthcare provider for guidance.

The recalled product

Product
AMOXICILLIN (AMOXICILLIN)
Brand
AMOXICILLIN
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Oral Antibiotic / Prescription
Hazard
Affected units
12

Is your product affected?

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

UPCs (8)

  • 0307816156526
  • 0307812020012
  • 0307816041587
  • 0307815060015
  • 0307815061012
  • 0307816157523
  • 0307816039584
  • 0307812613016

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 · AMOXICILLIN

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Same hazard · temperature abuse

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