Class II · Moderate risk Ongoing
Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division…
Reason CGMP Deviations
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA…
Reason CGMP Deviations
Class III · Low risk Ongoing
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals…
Reason Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class III · Low risk Ongoing
Everolimus tablets 2.5 mg, 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.
Class III · Low risk Ongoing
Everolimus tablets 10 mg, 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.
Class III · Low risk Ongoing
Everolimus tablets 7.5mg, 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.
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.
Class II · Moderate risk Ongoing
R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50…
Reason Presence of Particulate Matter
Class II · Moderate risk Ongoing
HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon…
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Ongoing
Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc…
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals…
Reason Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II · Moderate risk Ongoing
Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major…
Reason Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC…
Reason CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Class II · Moderate risk Ongoing
Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan sheng zhou kou shi…
Reason Marketed Without an Approved NDA/ANDA
Class II · Moderate risk Ongoing
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC…
Reason Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Class II · Moderate risk Ongoing
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217…
Reason CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot…
Class III · Low risk Ongoing
FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Ongoing
Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Ongoing
Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class I · High risk Ongoing
Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0
Reason Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Class II · Moderate risk Ongoing
Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden…
Reason Lack of Assurance of Sterility:
Class II · Moderate risk Ongoing
Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a)…
Reason CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable…
Class II · Moderate risk Ongoing
Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a)…
Reason CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable…
Class II · Moderate risk Ongoing
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a)…
Reason CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable…