Class II · Moderate risk Terminated
Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx
Reason cGMP deviations
FDA Drug Recalls
1,122 recalls, newest first
Class II · Moderate risk Terminated
Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle…
Reason cGMP deviations
Class II · Moderate risk Ongoing
Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC…
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Ongoing
Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC…
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Ongoing
Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC…
Reason Defective Delivery System: Out of specification for shear.
Class II · Moderate risk Ongoing
Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC…
Reason Defective Delivery System: Out of specification for shear.
Class III · Low risk Terminated
Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey…
Reason Failed Content Uniformity Specifications
Class II · Moderate risk Terminated
JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) bottles…
Reason Labeling: Label Mix-up
Class III · Low risk Ongoing
MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is…
Class II · Moderate risk Terminated
Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL…
Reason Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low…
Class II · Moderate risk Terminated
Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA…
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA…
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC…
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05)…
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC…
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c)…
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun…
Reason Subpotent Drug: low Anti-Factor IIa potency.
Class II · Moderate risk Completed
Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641…
Reason Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a…
Class II · Moderate risk Terminated
Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use…
Reason Labeling: Not elsewhere classified
Class I · High risk Ongoing
Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam…
Reason Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Class III · Low risk Terminated
Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC…
Reason Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related…
Class II · Moderate risk Terminated
Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide…
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for: All USA…
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by…
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 Oz (85g) plastic jars
Reason CGMP DEVIATIONS