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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 321–340 of 1,000 recalls

Class ITerminated

artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5

VIRGIN SCENT INC

Chemical Contamination: presence of benzene, acetaldehyde, and acetal.

October 26, 2021 · DrugView details →

Class ITerminated

Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceuticals LLC., Bloomington, IN 47403, USA, NDC: 67919-011-01

MERCK SHARP & DOHME CORP

Presence of Particulate Matter: Identified as Glass Particles

October 19, 2021 · DrugView details →

Class ITerminated

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50

Teligent Pharma, Inc.

Superpotent Drug

October 12, 2021 · DrugView details →

Class ICompleted

Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets

October 12, 2021 · DrugView details →

Class ITerminated

Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 20006106; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.

Bayer Healthcare Pharmaceuticals Inc.

Chemical Contamination: presence of benzene

October 1, 2021 · DrugView details →

Class ITerminated

Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.

Bayer Healthcare Pharmaceuticals Inc.

Chemical Contamination: presence of benzene

October 1, 2021 · DrugView details →

Class ITerminated

LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8

Bayer Healthcare Pharmaceuticals Inc.

Chemical Contamination: presence of benzene

October 1, 2021 · DrugView details →

Class ITerminated

Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 58720 6, NDC 11523-0010-2.

Bayer Healthcare Pharmaceuticals Inc.

Chemical Contamination: presence of benzene

October 1, 2021 · DrugView details →

Class ITerminated

LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3

Bayer Healthcare Pharmaceuticals Inc.

Chemical Contamination: presence of benzene

October 1, 2021 · DrugView details →

Class ITerminated

Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105

Bayer Healthcare Pharmaceuticals Inc.

Chemical Contamination: presence of benzene

October 1, 2021 · DrugView details →

Class ITerminated

Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 20066104 UPC 3 11017 41007 3, NDC 11523-0072-5

Bayer Healthcare Pharmaceuticals Inc.

Chemical Contamination: presence of benzene

October 1, 2021 · DrugView details →

Class ITerminated

LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7

Bayer Healthcare Pharmaceuticals Inc.

Chemical Contamination: presence of benzene

October 1, 2021 · DrugView details →

Class ITerminated

Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02870 1

Beiersdorf Inc

Chemical contamination; presence of benzene

September 30, 2021 · DrugView details →

Class ITerminated

Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4

Beiersdorf Inc

Chemical contamination; presence of benzene

September 30, 2021 · DrugView details →

Class ITerminated

Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 41100 00506 9

Beiersdorf Inc

Chemical contamination; presence of benzene

September 30, 2021 · DrugView details →

Class ITerminated

Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7

Beiersdorf Inc

Chemical contamination; presence of benzene

September 30, 2021 · DrugView details →

Class ITerminated

Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0

Beiersdorf Inc

Chemical contamination; presence of benzene

September 30, 2021 · DrugView details →

Class ITerminated

Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285; Glucagon, NDC: 0002-8031-01

Eli Lilly & Company

SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.

September 24, 2021 · DrugView details →

Class ITerminated

Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. Box 5290, Princeton, New Jersey 08540, NDC 49938-110-01.

Jacobus Pharmaceutical Company Inc.

Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.

September 9, 2021 · DrugView details →

Class ITerminated

AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17

ICU Medical Inc

Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.

September 3, 2021 · DrugView details →

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