FDA Drug Safety
U.S. Food and Drug Administration — Drug recalls and safety communications
17,379 recalls · Page 97 of 348
Moderate Jun 2, 2021
BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS
Cardinal Health Inc.
Moderate Jun 2, 2021
ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
Cardinal Health Inc.
Moderate Jun 2, 2021
MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS
Cardinal Health Inc.
Moderate Jun 2, 2021
Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only NDC 0069-0469-03 Distributed by Pfizer La…
Cardinal Health Inc.
Moderate Jun 2, 2021
Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day Rx only NDC 0378-4623-26 Manufactured for: Mylan Pharmaceuticals Inc.…
Cardinal Health Inc.
Moderate Jun 2, 2021
Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card c…
Cardinal Health Inc.
Moderate Jun 2, 2021
Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules Rx only NDC 64597-301-60 Manufactured by Patheon, Inc. Whitby,…
Cardinal Health Inc.
Moderate Jun 2, 2021
EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Phar…
Cardinal Health Inc.
Moderate Jun 2, 2021
Cetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC; TABLETS
Cardinal Health Inc.
Moderate Jun 2, 2021
VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080, NDC 0131-2480-35
Cardinal Health Inc.
Moderate Jun 2, 2021
Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license from: Kowa Company, Limited Tokyo 103-8433 Japan Tablets Man…
Cardinal Health Inc.
Critical Jun 2, 2021
NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count bottles (NDC 42192-327-07), …
Acella Pharmaceuticals, LLC
Moderate Jun 2, 2021
Acne Medication Benzoyl Peroxide Gel USP, 5% Net Wt 1.5 oz (42.5 g) NDC 0536-1055-56 Distributed by: Rugby Laboratories 31778 Enterprise Drive, Livon…
Cardinal Health Inc.
Moderate Jun 2, 2021
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Metered Inhalation 8,5 g Net Contents Rx only NDC 59310-…
Cardinal Health Inc.
Moderate Jun 2, 2021
CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP,150MG 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed…
Cardinal Health Inc.
Moderate Jun 2, 2021
Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-180-46 Distributed by: Kremers Urban Pharmaceuticals Inc. Prince…
Cardinal Health Inc.
Moderate Jun 2, 2021
COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683
Cardinal Health Inc.
Moderate Jun 2, 2021
Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per capsule 30 capsules Rx Only NDC 0456-1214-30 Distributed by Fore…
Cardinal Health Inc.
Moderate May 26, 2021
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius …
Fresenius Medical Care, North America
Low May 26, 2021
Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips Each), Manufactured b…
Nomax Inc
Moderate May 26, 2021
Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA N…
Teva Pharmaceuticals USA
Moderate May 26, 2021
PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
Hyobin LLC
Moderate May 26, 2021
Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
Hyobin LLC
Moderate May 26, 2021
Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil sheets in a box. Each box co…
Bit & Bet LLC
Low May 26, 2021
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
SigmaPharm Laboratories LLC
Moderate May 26, 2021
Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 Unit…
Lupin Pharmaceuticals Inc.
Moderate May 26, 2021
Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc…
Teva Pharmaceuticals USA
Moderate May 26, 2021
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvine, CA 92618 NDC 0703-4502-04
Teva Pharmaceuticals USA
Moderate May 26, 2021
Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA …
Teva Pharmaceuticals USA
Moderate May 26, 2021
PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
Hyobin LLC
Low May 26, 2021
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
SigmaPharm Laboratories LLC
Low May 26, 2021
Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940…
KVK-Tech, Inc.
Moderate May 26, 2021
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19…
Teva Pharmaceuticals USA
Moderate May 26, 2021
Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest,…
Pfizer Inc.
Low May 26, 2021
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 P…
SUN PHARMACEUTICAL INDUSTRIES INC
Moderate May 26, 2021
Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Lab…
Preferred Pharmaceuticals, Inc.
Critical May 19, 2021
BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution, CareFusion…
CareFusion 213, LLC
Moderate May 19, 2021
Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cran…
SUN PHARMACEUTICAL INDUSTRIES INC
Critical May 12, 2021
Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, Livonia, MI 48152; Packaged Exclusively B…
A-S Medication Solutions LLC.
Critical May 12, 2021
heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70% Topical Solution, 9.6 FL OZ. (285 mL) bottle, Hea…
PNHC, LLC.
Moderate May 12, 2021
IMPERIAL GOLD 2000, Male Sexual Performance Enhancement, 1 Capsule, UPC 718122040702
QMart
Low May 12, 2021
Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-227-01. Packa…
Heritage Pharmaceuticals Inc
Moderate May 12, 2021
Thumbs Up 7 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC., Made in USA, UPC 6 17135 89467 3.
Antoto-K
Moderate May 12, 2021
PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887
QMart
Moderate May 12, 2021
Imperial Platinum 2000, 1 capsule, UPC 718122040702
QMart
Moderate May 12, 2021
Burro en Primavera, 2 capsules, UPC 638632431055
QMart
Critical May 5, 2021
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25…
CareFusion 213, LLC
Moderate May 5, 2021
Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only, Repackaged by Preferred Pharm…
Preferred Pharmaceuticals, Inc.
Moderate May 5, 2021
Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S&B Shopper LLC. Little Ferry, NJ UPC 7 18122 04073 5
S & B Story LLC
Low May 5, 2021
Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, Inc. NDC:50…
Genentech Inc