Class II · Moderate risk
Streptomycin 24 mg/Dexamethasone 10 mg/mL Otic Injection
Lack of sterility assurance.
Is Dexamethasone recalled?
Yes — there is an active recall. 11 ongoing FDA recalls mention Dexamethasone (81 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dexamethasone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Dexamethasone recalls on record
none so far in 2026; 81 on record, newest first
Class II · Moderate risk
Dexamethasone 24 mg/mL Injection
Lack of sterility assurance.
Class II · Moderate risk
Dexamethasone
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
OZURDEX (dexamethasone intravitreal implant)
GMP Deviations: A silicone particulate was noted in Ozurdex.
Class II · Moderate risk
Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Dexamethasone Sodium Phosphate in all strengths
Lack of sterility assurance.
Class III · Low risk
Dexamethasone Sodium Phosphate Injection
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Class III · Low risk
Dexamethasone Sodium Phosphate Injection
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Class II · Moderate risk
Dexamethasone Sodium Phosphate all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class III · Low risk
Dexamethasone Elixir
Failed Impurities/ Degradation Specifications
Class II · Moderate risk
Dexamethasone Sodium Phosphate 24 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Dexamethasone Sodium Phosphate 200 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin 0.5% + Dexamethazone 0.1%
Lack of Assurance of Sterility
Class II · Moderate risk
Dexamethasone Sodium Phosphate PF
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Dex Combo
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Dex LA 8 (Dexamethasone acetate (8 mg/mL)
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
All Products Intended to be Sterile
Lack of Assurance of Sterility
Class II · Moderate risk
Dexamethasone 0.4% Opth Ointment
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
Dexamethasone 24 mg/mL Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Dexamethasone 4 mg/mL Iontophoresis
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Dexamethasone Sodium Phosphate active pharmaceutical ingredient…
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.
Class II · Moderate risk
Dexamethasone Base 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.
Class II · Moderate risk
Dexamethasone
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.
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