Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05)…
Reason Failed Dissolution Specifications
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez…
Reason CGMP Deviations: Market complaints received for gritty texture (grainy)
Class II · Moderate risk Ongoing
Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO…
Reason CGMP Deviations
Class I · High risk Ongoing
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota…
Reason Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc…
Reason Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved…
Class II · Moderate risk Ongoing
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health…
Reason Failed Dissolution Specifications.
Class II · Moderate risk Ongoing
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals…
Reason Failed Tablet/Capsule Specifications
Class II · Moderate risk Ongoing
edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) Uptown Medi Spa, Phoenix, AZ.
Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with…
Class II · Moderate risk Ongoing
Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 g), University Skin Institute, 650 University Ave…
Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with…
Class II · Moderate risk Ongoing
mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Skin Rx Beverly Hills, CA 90210
Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with…
Class II · Moderate risk Ongoing
Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz (201 g), Torreypines.com
Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with…
Class II · Moderate risk Ongoing
Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly Hills…
Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with…
Class II · Moderate risk Ongoing
ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverly Hills, CA 90210
Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with…
Class III · Low risk Ongoing
Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
Reason Labeling: Not Elsewhere Classified
Class III · Low risk Ongoing
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B…
Reason Tablet/Capsules Imprinted with Wrong ID
Class III · Low risk Ongoing
Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B…
Reason Tablet/Capsules Imprinted with Wrong ID
Class II · Moderate risk Ongoing
Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed…
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk Ongoing
Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed…
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk Ongoing
Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed…
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk Ongoing
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by…
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk Ongoing
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by…
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk Ongoing
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario…
Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by…
Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk Ongoing
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in…
Reason cGMP deviations: Temperature excursion during transportation.
Class III · Low risk Ongoing
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par…
Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.