Class II · Moderate risk
Betamethasone Dipropionate Ointment USP
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Is Betamethasone recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Betamethasone (49 total). Check the affected lots below.
Most common reason: Sterility / contamination (22 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Betamethasone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Betamethasone recalls on record
none so far in 2026; 49 on record, newest first
Class II · Moderate risk
Celestone Soluspan
cGMP deviations: Temperature abuse
Class II · Moderate risk
Betamethasone Dipropionate Cream USP
cGMP deviations: Temperature abuse
Class II · Moderate risk
Betamethasone Dipropionate Lotion USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class III · Low risk
Clotrimazole and Betamethasone Dipropionate Cream USP
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Class II · Moderate risk
Betamethasone Dipropionate Lotion USP
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
Class II · Moderate risk
Betamethasone Dipropionate Lotion USP
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Class III · Low risk
Betamethasone Dipropionate Ointment USP
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Class III · Low risk
Betamethasone Dipropionate Ointment USP
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Class III · Low risk
Betamethasone Dipropionate Ointment USP
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Class II · Moderate risk
Betamethasone Acetate/Betamethasone
Lack of Assurance of Sterility
Class II · Moderate risk
Betamethasone Acetate/Betamethasone
Lack of Assurance of Sterility
Class II · Moderate risk
Betamethasone Acetate/Betamethasone
Lack of Assurance of Sterility
Class III · Low risk
Clotrimazole and Betamethasone Dipropionate Cream USP
Temperature Abuse: Complaints received of liquidy texture.
Class III · Low risk
Betamethasone Dipropionate Ointment USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Betamethasone Sodium Phosphate & Betamethasone Acetate all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Betamethasone 0.25%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class III · Low risk
Taclonex (calcipotriene and betamethasone dipropionate)
Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Class II · Moderate risk
Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension
Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of the potential of drug clumps in the vial of the sterile drug product and larger particle sizes.
Class II · Moderate risk
Clotrimazole 1%/ Betamethasone Dipropionate 0.05% Otic Solution
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
All betamethasone diproprionate Products
Lack of Processing Controls
Class II · Moderate risk
Betamethasone SP 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
Betamethasone SP
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
Betamethasone Combo PF 2 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
Betamethasone Combo 10 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.
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