The Recall Desk
HighFDA (Drugs)·D-1330-2022·Announced 2022-08-17

Prednisone Tablets Recalled for Contamination With Wrong-Strength Tablets

Strides Pharma is recalling Prednisone 20 mg tablets due to contamination with 2.5 mg tablets. No illnesses have been reported, but patients may receive incorrect doses.

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 involving contamination with wrong-strength tablets in a prescription corticosteroid medication. No illnesses reported, but the contamination creates risk of dosing errors with a prescription medication, qualifying as a risk-of-harm product under Score 3 criteria.

Plain-English summary

Strides Pharma Inc. is recalling Prednisone Tablets USP, 20 mg, because some bottles contain a 2.5 mg tablet mixed in with the 20 mg tablets. This is an FDA Class II recall.

The contamination creates a risk that patients may inadvertently receive the wrong dose of the medication. No illnesses or injuries have been reported to date.

The recall affects approximately 1,032 bottles with lot number 7248988B and an expiration date of 9/2023, distributed nationwide throughout the United States.

Patients who have a bottle from this lot should contact their pharmacy or healthcare provider to confirm whether their supply is affected and to obtain a replacement.

The recalled product

Product
PREDNISONE (PREDNISONE)
Brand
PREDNISONE
Manufacturer
Strides Pharma Inc.
Hazard
  • foreign-tablet
  • dosing-error

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)

  • Lot #: 7248988B
  • Exp 9/2023

UPCs (3)

  • 0364380949060
  • 0364380785064
  • 0364380784067

Distribution

Distributed nationwide across the United States.