Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Prednisone recalled?

Not under an active recall. Prednisone was recalled 11 times in the past — all now closed. Most recent: Jul 19, 2022.

Most common reason: Labeling / mix-up (4 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Prednisone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Prednisone recalls on record

none so far in 2026; 11 on record, newest first
Class II · Moderate risk

PredniSONE Tablets

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Terminated Temperature excursion Cardinal Healthcare D-0193-2024
Class II · Moderate risk

Prednisone Tablets

Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg

Terminated Labeling / mix-up Lannett Company, Inc. NDC 0527-2931-37 D-1508-2020
Class II · Moderate risk

PredniSONE Tablets USP

Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.

Terminated Failed specification West-Ward Pharmaceutical NDC 0054-4741-25 D-0008-2017
Class III · Low risk

Prednisone 20 mg

Labeling: Not elsewhere classified. NDC number is incorrect on the container.

Terminated Labeling / mix-up Northwind Pharmaceuticals LLC NDC 51655-320-53 D-0485-2016
Class II · Moderate risk

Prednisone active pharmaceutical ingredient packaged in varying…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-858-2015
Class II · Moderate risk

predniSONE

Labeling: Label Mixup:predniSONE, Tablet, 20 mg may have potentially been mislabeled as the following drug: methylPREDNISolone, Tablet, 4 mg, NDC 00781502201, Pedigree: AD54587_7, EXP: 5/21/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-976-2014
Class III · Low risk

Prednisone Tablet USP

Labeling: Missing Label; missing label on blister card

Terminated Labeling / mix-up Boehringer Ingelheim Roxane Inc NDC 0054-0018-20 D-882-2013
Class II · Moderate risk

Prednisone tablets

Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions

Terminated Particulate / foreign matter L. Perrigo Co. D-125-2013
Class II · Moderate risk

PredniSONE Tablets

Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.

Terminated Particulate / foreign matter West-ward Pharmaceutical Corp. NDC 0143-1473-01 D-149-2013
Class II · Moderate risk

PredniSONE Tablets

Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions.

Terminated Particulate / foreign matter West-ward Pharmaceutical Corp. NDC 0143-1477-01 D-133-2013