The Recall Desk
HighFDA (Drugs)·D-0168-2023·Announced 2023-02-01

Allopurinol Tablets Recalled for Green Plastic Contamination

Accord Healthcare is recalling Allopurinol 100 mg tablets due to the presence of a small piece of green plastic embedded in some tablets. The plastic poses a potential choking and ingestion hazard.

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: This is an FDA Class II recall of a risk-of-harm product (foreign object contamination). Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Accord Healthcare, Inc. is recalling Allopurinol Tablets USP, 100 mg, in 100-count bottles due to the presence of a small piece of green plastic embedded in the tablet. The recalled product was distributed nationwide in the United States.

The green plastic piece poses a potential choking and ingestion hazard to patients. The recall includes 87,576 bottles with lot numbers R2200455 and R2200456, with an expiration date of March 2025.

Patients who have obtained the recalled medication should contact their pharmacy or healthcare provider.

The recalled product

Product
ALLOPURINOL (ALLOPURINOL)
Brand
ALLOPURINOL
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Prescription Tablet
Hazard
  • foreign-object
  • choking-hazard

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 (2)

  • Lots: R2200455
  • R2200456 Exp. 03/2025

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · ALLOPURINOL

Same category