Class II · Moderate risk
prednisoLONE Acetate Ophthalmic Suspension
Presence of Foreign Substance
Is Prednisolone recalled?
Yes — there is an active recall. 6 ongoing FDA recalls mention Prednisolone (34 total). Check the affected lots below.
Most common reason: Sterility / contamination (13 of these recalls)
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 in 2026
3 initiated in 2026, 34 in total — newest first
Class III · Low risk
Pred Mild
Failed Stability Specifications
Class II · Moderate risk
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Class II · Moderate risk
Prednisolone Oral Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
PrednisoLONE Oral Solution USP
Defective Container: Product has incomplete induction seals.
Class II · Moderate risk
Prednisolone Acetate Ophthalmic Suspension
cGMP deviations: Temperature abuse
Class III · Low risk
Prednisolone Sodium Phosphate Oral Solution
Discoloration: Out of Specification (OOS) result for APHA Color Test.
Class II · Moderate risk
Prednisolone Sodium Phosphate Oral Solution
Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
Class II · Moderate risk
Prednisolone 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Prednisolone and Bromfenac Ophthalmic Solution
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Gatifloxacin and Bromfenac
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%
Lack of sterility assurance.
Class III · Low risk
Prednisolone and Gatifloxacin Ophthalmic Solution
Presence of precipitate
Class II · Moderate risk
Prednisolone Sodium Phosphate Oral Solution
Defective Container: Tamper Evident foil seal not completely intact.
Class II · Moderate risk
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
PrednisoLONE 10 mg Tablet
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Blephamide
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Class III · Low risk
PrednisoLONE Oral Solution USP
Failed Stability Specifications
Class II · Moderate risk
Placebo for Prednisolone Acetate 1%
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
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