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

Yes — there is an active recall. 6 ongoing FDA recalls mention Prednisolone (34 total). Check the affected lots below.

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

Prednisolone recalls on record

none so far in 2026; 34 on record, newest first
Class II · Moderate risk

Blephamide

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Terminated Particulate / foreign matter Allergan Sales, LLC NDC 0023-0313-04 D-1820-2015
Class II · Moderate risk

Prednisolone Anhydrous Micronized active pharmaceutical…

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-857-2015
Class II · Moderate risk

Prednisolone Anhydrous active pharmaceutical ingredient packaged…

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-856-2015
Class II · Moderate risk

Prednisolone Acetate active pharmaceutical ingredient packaged in…

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-855-2015
Class II · Moderate risk

PREDNISOLONE Sodium Phosphate

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Oregon Compounding Centers, Inc. dba Creative Compounds D-0219-2015
Class II · Moderate risk

Prednisolone acetate 50 mg/mL injectable packaged in an amber glass injectable vial

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Terminated Sterility / contamination Martin Avenue Pharmacy, Inc. D-0124-2015
Class II · Moderate risk

prednisoLONE

Labeling: Label Mixup; prednisoLONE, Tablet, 5 mg may be potentially mislabeled as ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, NDC 00597000160, Pedigree: W003644, EXP: 8/24/2013.

Terminated Labeling / mix-up Aidapak Services, LLC D-513-2014
Class II · Moderate risk

Prednisolone Acetate 10mg/Ml Injectable 10 Mls

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1606-2012