FDA Drug Recalls

1,523 recalls · Class III, newest first

Class III · Low risk Terminated Apr 19, 2021

Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10

Reason Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor…

SigmaPharm Laboratories LLC NDC 42794-017-10 D-0380-2021

Class III · Low risk Terminated Apr 19, 2021

Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.

Reason Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor…

SigmaPharm Laboratories LLC NDC 42794-016-10 D-0379-2021

Class III · Low risk Terminated Apr 13, 2021

Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips…

Reason Subpotent Drug

Nomax Inc D-0387-2021

Class III · Low risk Terminated Mar 29, 2021

Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC…

Reason Failed Stability Specifications: product did not meet viscosity results.

Teligent Pharma, Inc. NDC 52565-008-14 D-0331-2021

Class III · Low risk Terminated Mar 25, 2021

Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical…

Reason Failed Moisture Limits: Out of specification for water content

Sun Pharmaceutical Industries INC NDC 62756-142-02 D-0325-2021

Class III · Low risk Terminated Mar 22, 2021

Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ…

Reason Failed Impurities/Degradation Specifications

Macleods Pharma Usa Inc NDC 33342-114-10 D-0329-2021

Class III · Low risk Terminated Mar 18, 2021

LCL-2-0191, 5 gallon carboys, Rx only, Manufactured for: LaCore Labs, LLC, by: Washington Homeopathic Products, Inc.260 J R…

Reason An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.

Washington Homeopathic Products, Inc. D-0323-2021

Class III · Low risk Terminated Mar 18, 2021

Sp-4, 100 mL solution bottles, Rx only, Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West…

Reason An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.

Washington Homeopathic Products, Inc. D-0322-2021

Class III · Low risk Terminated Mar 18, 2021

Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural Ophthalmics Inc. PO Box 1510 Dillon, CO…

Reason An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.

Washington Homeopathic Products, Inc. NDC 58770-190-42 D-0321-2021

Class III · Low risk Terminated Mar 9, 2021

Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen…

Reason Temperature Abuse

Cardinal Health Inc. NDC 57894-640-01 D-0314-2021

Class III · Low risk Terminated Mar 4, 2021

Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01

Reason Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.

Teva Pharmaceuticals USA NDC 0703-4004-01 D-0309-2021

Class III · Low risk Terminated Mar 2, 2021

Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of Menotropins for injection, 5 single dose vials…

Reason Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP

Ferring Pharmaceuticals Inc NDC 55566-7501-2 D-0299-2021

Class III · Low risk Terminated Feb 22, 2021

Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only…

Reason Subpotent

Sun Pharmaceutical Industries INC NDC 47335-506-96 D-0289-2021

Class III · Low risk Terminated Feb 19, 2021

Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc…

Reason Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-001-03 D-0298-2021

Class III · Low risk Terminated Feb 19, 2021

Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05…

Reason Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities

Dr. Reddy's Laboratories, Inc. NDC 55111-123-90 D-0291-2021

Class III · Low risk Terminated Feb 17, 2021

Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC…

Reason Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage…

Edge Pharma, LLC NDC 05446-1600-05 D-0306-2021

Class III · Low risk Terminated Feb 5, 2021

Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury…

Reason Failed Impurity/Degradation Specifications

Sun Pharmaceutical Industries INC NDC 62756-129-40 D-0251-2021

Class III · Low risk Terminated Feb 2, 2021

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc…

Reason Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.

Teligent Pharma, Inc. NDC 63739-996-15 D-0340-2021

Class III · Low risk Terminated Feb 2, 2021

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc…

Reason Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.

Teligent Pharma, Inc. NDC 52565-019-51 D-0339-2021

Class III · Low risk Terminated Feb 2, 2021

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc…

Reason Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.

Teligent Pharma, Inc. NDC 52565-019-15 D-0338-2021

Class III · Low risk Terminated Jan 29, 2021

Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX…

Reason Failed Dissolution Specifications

Akebia Therapeutics dba Keryx Biopharmaceutials, Inc NDC 59922-0631-01 D-0260-2021

Class III · Low risk Terminated Jan 28, 2021

Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare…

Reason Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials

Accord Healthcare, Inc. NDC 16729-472-08 D-0250-2021

Class III · Low risk Terminated Jan 21, 2021

Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin…

Reason Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.

Lupin Pharmaceuticals Inc. D-0247-2021

Class III · Low risk Terminated Jan 15, 2021

Benzphetamine tablets, 50mg, CIII, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC…

Reason Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50…

Calvin Scott & Company, Inc. NDC 10702-0040-50 D-1123-2022

Class III · Low risk Terminated Jan 11, 2021

Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial Distributed by: Sun Pharma…

Reason Incorrect Labeling: Incorrect lot number on secondary packaging

Sun Pharmaceutical Industries INC NDC 62756-015-40 D-0242-2021