Drugs Recalls

FDA Drug Class III Ongoing

Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL

November 26, 2025 SOMERSET THERAPEUTICS LLC 71,310 10mL vials units

FDA Drug Class III Ongoing

Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01

November 26, 2025 Winder Laboratories, LLC 3,528 30 mL Bottles units

FDA Drug Class III Ongoing

Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single d

November 26, 2025 SOMERSET THERAPEUTICS LLC 28,660 20mL vials units

FDA Drug Class III Ongoing

Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-do

November 26, 2025 SOMERSET THERAPEUTICS LLC 52,340 5mL vials units

FDA Drug Class III Ongoing

Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, I

November 26, 2025 Sun Pharmaceutical Industries Inc.

FDA Drug Class II Ongoing

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmac

November 24, 2025 Breckenridge Pharmaceutical, Inc 7389 bottles units

FDA Drug Class II Ongoing

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmac

November 24, 2025 Breckenridge Pharmaceutical, Inc 3397 bottles units

FDA Drug Class III Ongoing

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-8

November 21, 2025 Glenmark Pharmaceuticals Inc., USA 11,136 bottles units

FDA Drug Class II Ongoing

Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 871

November 20, 2025 Fagron Compounding Services 2980 syringes units

FDA Drug Class III Ongoing

Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy,

November 18, 2025 Glenmark Pharmaceuticals Inc., USA 672 90-count bottles units

FDA Drug Class II Ongoing

Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01

November 17, 2025 Preferred Pharmaceuticals, Inc 575 1x10 Foil Blister Packs units

FDA Drug Class II Ongoing

Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02

November 14, 2025 Cipla USA, Inc. 12,576 bottles units

FDA Drug Class II Ongoing

Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02

November 14, 2025 Cipla USA, Inc. 63,504 bottles units

FDA Drug Class II Ongoing

Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02

November 14, 2025 Cipla USA, Inc. 15,744 bottles units

FDA Drug Class II Ongoing

Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Man

November 13, 2025 Lupin Pharmaceuticals Inc. 32736 vials units

FDA Drug Class II Ongoing

Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01

November 12, 2025 Medical Products Laboratories, Inc. 41,328 bottles units

FDA Drug Class III Ongoing

Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56

November 11, 2025 Dr. Reddy's Laboratories, Inc. 4800 54-count bottles units

FDA Drug Class III Ongoing

Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, I

November 7, 2025 Teva Pharmaceuticals USA, Inc. 15,944 cartons units

FDA Drug Class I Ongoing

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).

November 6, 2025 Fresenius Kabi USA, LLC 2,199,850 vials units

FDA Drug Class II Ongoing

Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.

November 5, 2025 Lupin Pharmaceuticals Inc. 52,128 bottles units

FDA Drug Class II Ongoing

Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-

October 31, 2025 Blossom Pharmaceuticals 33000 containers units

FDA Drug Class II Ongoing

Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 7

October 31, 2025 Blossom Pharmaceuticals 912 containers units

FDA Drug Class II Ongoing

Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04.

October 31, 2025 Blossom Pharmaceuticals 1560 containers units

FDA Drug Class II Ongoing

Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.

October 31, 2025 Blossom Pharmaceuticals 18912 containers units

FDA Drug Class II Ongoing

Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distribute

October 31, 2025 Novocol Pharmaceutical of Canada, Inc.

FDA Drug Class II Ongoing

Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.

October 31, 2025 Blossom Pharmaceuticals 2400 containers units

FDA Drug Class II Ongoing

darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactur

October 31, 2025 Novocol Pharmaceutical of Canada, Inc. 5,520 Cartons units

FDA Drug Class II Ongoing

Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03.

October 31, 2025 Blossom Pharmaceuticals 7944 containers units

FDA Drug Class II Ongoing

3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply

October 31, 2025 Novocol Pharmaceutical of Canada, Inc. 5,825 units

FDA Drug Class II Ongoing

Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.

October 31, 2025 Blossom Pharmaceuticals 7920 bottles units

FDA Drug Class II Ongoing

Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07

October 31, 2025 Cipla Limited 4,438 10x1mL cartons units

FDA Drug Class II Ongoing

Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01.

October 31, 2025 Blossom Pharmaceuticals 12150 bottles units

FDA Drug Class II Ongoing

2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply

October 31, 2025 Novocol Pharmaceutical of Canada, Inc. 18,789 cartons- 50 cartridges /carton units

FDA Drug Class II Ongoing

Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.

October 31, 2025 Blossom Pharmaceuticals 9600 containers units

FDA Drug Class II Ongoing

OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed b

October 31, 2025 Novocol Pharmaceutical of Canada, Inc. 1,636 cartons units

FDA Drug Class II Ongoing

Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01.

October 31, 2025 Blossom Pharmaceuticals 13536 containers units

FDA Drug Class II Ongoing

Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-5

October 31, 2025 Blossom Pharmaceuticals 14700 bottles units

FDA Drug Class II Ongoing

Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of

October 31, 2025 Novocol Pharmaceutical of Canada, Inc. 40 cartons units

FDA Drug Class II Ongoing

Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson De

October 31, 2025 Novocol Pharmaceutical of Canada, Inc. 12,033 cartons units

FDA Drug Class II Ongoing

Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016.

October 31, 2025 Blossom Pharmaceuticals 8184 bottles units

FDA Drug Class II Ongoing

WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY 10941, Made in India, NDC 67777-223-05.

October 31, 2025 Blossom Pharmaceuticals 2592 bottles units

FDA Drug Class I Ongoing

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26

October 29, 2025 Otsuka ICU Medical LLC

FDA Drug Class I Ongoing