Drugs Recalls
17,415 recalls in this category
FDA Drug
Class I
Terminated
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5
October 2, 2023
Pfizer Inc.
24,900 vials units
FDA Drug
Class II
Terminated
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
October 2, 2023
Pine Pharmaceuticals, LLC
128 bags units
FDA Drug
Class II
Terminated
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
October 2, 2023
Pine Pharmaceuticals, LLC
860 syringes units
FDA Drug
Class II
Terminated
ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA
September 29, 2023
Biomic Sciences, LLC dba ION Intelligence of Nature
N/A units
FDA Drug
Class I
Terminated
ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA
September 29, 2023
Biomic Sciences, LLC dba ION Intelligence of Nature
N/A units
FDA Drug
Class II
Terminated
Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA
September 29, 2023
Biomic Sciences, LLC dba ION Intelligence of Nature
N/A units
FDA Drug
Class II
Ongoing
Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Dist
September 28, 2023
Padagis US LLC
10,512 cartons units
FDA Drug
Class II
Ongoing
Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intra-articular use only, Shake Well, Not for IV/ID, intraocular
September 28, 2023
Eugia US LLC
1,626 vials units
FDA Drug
Class I
Completed
BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 75788-115-04
September 25, 2023
Scynexis, Inc.
17,376 units
FDA Drug
Class III
Ongoing
Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. NDC: 0054-8550-25
September 22, 2023
West-Ward Columbus Inc
2,673 cartons units
FDA Drug
Class II
Terminated
HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2
September 21, 2023
Central Admixture Pharmacy Services, Inc.
274 30 mL syringes units
FDA Drug
Class II
Terminated
fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-
September 21, 2023
Central Admixture Pharmacy Services, Inc.
5,378 100 mL bags units
FDA Drug
Class II
Terminated
rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1
September 21, 2023
Central Admixture Pharmacy Services, Inc.
1,389 5 mL syringes units
FDA Drug
Class II
Terminated
ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
September 21, 2023
Central Admixture Pharmacy Services, Inc.
1,590 5 mL Syringes. units
FDA Drug
Class II
Terminated
HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1
September 21, 2023
Central Admixture Pharmacy Services, Inc.
2,664 30 mL syringes units
FDA Drug
Class II
Terminated
lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1
September 21, 2023
Central Admixture Pharmacy Services, Inc.
1,992 5 mL syringes units
FDA Drug
Class II
Terminated
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3
September 21, 2023
Central Admixture Pharmacy Services, Inc.
476, 50 mL Syringes units
FDA Drug
Class II
Terminated
HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1
September 21, 2023
Central Admixture Pharmacy Services, Inc.
398 5 mL syringes units
FDA Drug
Class II
Terminated
PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-600
September 21, 2023
Central Admixture Pharmacy Services, Inc.
19,510 10 mL syringes. units
FDA Drug
Class II
Terminated
fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5
September 21, 2023
Central Admixture Pharmacy Services, Inc.
1,792 bags units
FDA Drug
Class II
Terminated
fentaNYL in 0.9% sodium chloride, 5,000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1
September 21, 2023
Central Admixture Pharmacy Services, Inc.
403 bags units
FDA Drug
Class II
Terminated
fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
September 21, 2023
Central Admixture Pharmacy Services, Inc.
688 50 mL syringes units
FDA Drug
Class II
Terminated
PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
September 21, 2023
Central Admixture Pharmacy Services, Inc.
3,384 10 mL syringes units
FDA Drug
Class II
Terminated
fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1
September 21, 2023
Central Admixture Pharmacy Services, Inc.
50, 3 mL syringes units
FDA Drug
Class II
Terminated
fentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5
September 21, 2023
Central Admixture Pharmacy Services, Inc.
71 100 mL bags units
FDA Drug
Class II
Terminated
HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-20
September 21, 2023
Central Admixture Pharmacy Services, Inc.
1,190 30 mL syringes units
FDA Drug
Class II
Terminated
fentaNYL, 1,250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7
September 21, 2023
Central Admixture Pharmacy Services, Inc.
1,459 30 mL syringes units
FDA Drug
Class II
Terminated
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road,
September 21, 2023
Central Admixture Pharmacy Services, Inc.
190 250 mL bags units
FDA Drug
Class II
Terminated
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-7
September 21, 2023
Central Admixture Pharmacy Services, Inc.
1,762 Syringes units
FDA Drug
Class II
Terminated
PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1
September 21, 2023
Central Admixture Pharmacy Services, Inc.
3,081 syringes units
FDA Drug
Class II
Terminated
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, In
September 21, 2023
Zydus Pharmaceuticals USA Inc
7,248 bottles units
FDA Drug
Class II
Terminated
fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2071-2
September 21, 2023
Central Admixture Pharmacy Services, Inc.
598 10 mL syringes units
FDA Drug
Class II
Terminated
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1
September 21, 2023
Central Admixture Pharmacy Services, Inc.
1,767 3 mL syringes units
FDA Drug
Class II
Terminated
fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2
September 21, 2023
Central Admixture Pharmacy Services, Inc.
174, 5 mL syringes. units
FDA Drug
Class II
Terminated
fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbr
September 21, 2023
Central Admixture Pharmacy Services, Inc.
895 50 mL syringes units
FDA Drug
Class II
Terminated
ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
September 21, 2023
Central Admixture Pharmacy Services, Inc.
4,775 5 mL Syringes units
FDA Drug
Class II
Terminated
succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6011-2
September 21, 2023
Central Admixture Pharmacy Services, Inc.
3,590 10 mL syringes units
FDA Drug
Class II
Terminated
HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1
September 21, 2023
Central Admixture Pharmacy Services, Inc.
4,550 30 mL syringes units
FDA Drug
Class II
Terminated
midazolam in dextrose 5%, 50 mg/50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1
September 21, 2023
Central Admixture Pharmacy Services, Inc.
419 50 mL syringes units
FDA Drug
Class II
Terminated
fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2001-2
September 21, 2023
Central Admixture Pharmacy Services, Inc.
962 30 mL syringes. units
FDA Drug
Class II
Terminated
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4
September 21, 2023
Central Admixture Pharmacy Services, Inc.
240 100 mL bags units
FDA Drug
Class II
Terminated
HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2
September 21, 2023
Central Admixture Pharmacy Services, Inc.
1,190 50 mL syringes units
FDA Drug
Class II
Terminated
fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbroo
September 21, 2023
Central Admixture Pharmacy Services, Inc.
60 250 mL bags units
FDA Drug
Class I
Terminated
Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01.
September 20, 2023
KVK-Tech, Inc.
1488 bottles units
FDA Drug
Class III
Terminated
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07
September 20, 2023
Imprimis NJOF, LLC
6,228 bags + 15,360 boxes units
FDA Drug
Class III
Terminated
Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75, Manufactured by: Tolmar Inc., Fort Collins, CO 80526,
September 12, 2023
Tolmar, Inc.
2990 cartons units
FDA Drug
Class I
Ongoing
TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 97029 70000 6, manufactured for Church & Dwight Co, Inc., Ewing, N
September 8, 2023
Church & Dwight Inc
5,316 bottles units
FDA Drug
Class I
Ongoing
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Cor
September 8, 2023
Novartis Pharmaceuticals Corp.
1272 bottles units
FDA Drug
Class III
Terminated
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances
September 7, 2023
Sun Pharmaceutical Industries Inc.
69,707 cartons units
FDA Drug
Class II
Terminated
Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in
September 5, 2023
BE PHARMACEUTICALS AG
41,148 vials units