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Is Clobetasol recalled?

26 FDA recalls mention Clobetasol. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Clobetasol.

Class II · Moderate risk Ongoing Apr 26, 2023

Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL…

Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. D-0796-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031…

Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. D-0795-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed by: Akorn…

Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. D-0794-2023

Class III · Low risk Terminated Jan 20, 2023

Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland…

Reason Subpotent Drug: Low assay result observed during long-term stability testing.

Lupin Pharmaceuticals Inc. NDC 68180-956-03 D-0174-2023

Class II · Moderate risk Terminated Mar 23, 2022

Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx Only, Mfg: Teligent Pharma, Inc., PREFERRED…

Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability…

Preferred Pharmaceuticals, Inc. NDC 68788-7768-01 D-0768-2022

Class II · Moderate risk Terminated Mar 15, 2022

Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge…

Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Teligent Pharma, Inc. NDC 70512-028-60 D-0700-2022

Class II · Moderate risk Terminated Mar 15, 2022

Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, NDC 52565-082-30; c) 60 grams…

Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Teligent Pharma, Inc. NDC 52565-082-15 D-0674-2022

Class II · Moderate risk Terminated Mar 15, 2022

Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-039-30; c)…

Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Teligent Pharma, Inc. NDC 52565-039-15 D-0673-2022

Class II · Moderate risk Terminated Mar 15, 2022

Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles…

Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Teligent Pharma, Inc. NDC 52565-055-02 D-0672-2022

Class II · Moderate risk Terminated Mar 15, 2022

Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; b) 30 grams tube, NDC…

Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Teligent Pharma, Inc. NDC 52565-094-15 D-0671-2022

Class II · Moderate risk Terminated Mar 15, 2022

Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-30; c) 45…

Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Teligent Pharma, Inc. NDC 52565-051-15 D-0670-2022

Class II · Moderate risk Terminated Jan 10, 2022

Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only…

Reason CGMP Deviations

Ingenus Pharmaceuticals Llc NDC 50742-304-50 D-0374-2022

Class I · High risk Terminated Dec 15, 2021

Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel…

Reason Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria

Taro Pharmaceuticals U.S.A., Inc. NDC 51672-1259-3 D-0375-2022

Class III · Low risk Terminated Nov 5, 2020

Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60

Reason Superpotent and Subpotent; low and high assay results

Teligent Pharma, Inc. NDC 52565-039-60 D-0119-2021

Class III · Low risk Terminated Jul 24, 2020

Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-902-15) and b) 45g Tubes (NDC 60429-902-45), Rx Only…

Reason Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.

Golden State Medical Supply Inc. NDC 60429-902-15 D-1497-2020

Class III · Low risk Terminated Jul 20, 2020

Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External…

Reason Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.

Taro Pharmaceuticals U.S.A., Inc. D-1496-2020

Class II · Moderate risk Terminated Apr 6, 2020

Clobetasol Mouth Rinse 0.05% Solution 450 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Reason Lack of Processing Control

The Medicine Shoppe Pharmacy D-1207-2020

Class III · Low risk Terminated Nov 15, 2019

Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx…

Reason Defective delivery system; product is not foaming or is coming out as liquid.

Glenmark Pharmaceuticals Inc., USA NDC 68462-625-27 D-0619-2020

Class III · Low risk Terminated Nov 15, 2019

Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manufactured…

Reason Defective delivery system; product is not foaming or is coming out as liquid.

Glenmark Pharmaceuticals Inc., USA NDC 68462-608-27 D-0618-2020

Class III · Low risk Terminated Jan 25, 2019

Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only…

Reason Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.

Akorn Inc NDC 50383-270-30 D-0515-2019

Class III · Low risk Terminated Jan 11, 2019

Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ…

Reason Defective Container; complaints of leakage.

Oxalis Labs NDC 33342-321-86 D-0492-2019

Class III · Low risk Terminated Dec 21, 2017

Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel…

Reason Failed Content Uniformity Specifications

Taro Pharmaceuticals U.S.A., Inc. NDC 51672-1258-3 D-0249-2018

Class III · Low risk Terminated Jun 2, 2017

G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 0713-0656-31, c) 45 g…

Reason Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a…

G & W Laboratories, Inc. NDC 0713-0656-15 D-0945-2017

Class II · Moderate risk Terminated Feb 10, 2017

CLOBETASOL 0.05% IN OLEA BASE, CLOBETASOL 0.05% IN OROBASE, CLOBETASOL 0.05% OINTMENT, CLOBETASOL 0.05%/ SODIUM, SULFACETAMIDE…

Reason Lack of Assurance of Sterility: There are also CGMP Deviations.

Synergy Rx D-0535-2017

Class II · Moderate risk Terminated Mar 25, 2016

All clobetasol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA…

Reason Lack of Processing Controls

Reliable Rexall-A Compounding Pharmacy D-1128-2016