FDA Drug Recalls

56 recalls · Class I, newest first

Class I · High risk Completed May 21, 2025

UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC…

Reason Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.

Umary-USA.com D-0493-2025

Class I · High risk Completed May 21, 2025

UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7…

Reason Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and…

Umary-USA.com D-0492-2025

Class I · High risk Completed Apr 29, 2024

Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36…

Reason Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

Hikma Injectables USA Inc NDC 63037-123-25 D-0508-2024

Class I · High risk Completed Feb 1, 2024

TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight…

Reason Chemical Contamination; presence of benzene.

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company D-0346-2024

Class I · High risk Completed Dec 21, 2023

Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp…

Reason Chemical Contamination: presence of benzene

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company NDC 63736-378-02 D-0236-2024

Class I · High risk Completed Nov 22, 2023

TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: Insight…

Reason Chemical Contamination; presence of benzene.

Insight Pharmaceuticals Corporation D-0151-2024

Class I · High risk Completed Nov 17, 2023

Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc…

Reason Defective Container: powder may leak out of the pouch

InvaGen Pharmaceuticals, Inc. NDC 69097-964-53 D-0220-2024

Class I · High risk Completed Sep 25, 2023

BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey…

Reason Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial…

Scynexis, Inc. NDC 75788-115-04 D-0042-2024

Class I · High risk Completed May 24, 2022

Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles, Melchor Ocampo No. 55 Local D, Delegacion…

Reason Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory…

Walmart Inc D-1157-2022

Class I · High risk Completed Apr 5, 2022

Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC…

Reason TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.

Cardinal Health Inc. NDC 0002-8799-59 D-0882-2022

Class I · High risk Completed Mar 24, 2022

Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per…

Reason Microbial Contamination of Non-Sterile Products

Plastikon Healthcare LLC D-0868-2022

Class I · High risk Completed Mar 24, 2022

MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For…

Reason Microbial Contamination of Non-Sterile Products

Plastikon Healthcare LLC NDC 0904-6846-73 D-0867-2022

Class I · High risk Completed Mar 4, 2022

SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC…

Reason Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.

Fagron, Inc NDC 51552-1123-5 D-0856-2022

Class I · High risk Completed Nov 19, 2021

AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bottle with…

Reason Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

American Screening LLC D-0266-2022

Class I · High risk Completed Nov 17, 2021

Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx…

Reason Temperature Abuse; temperature excursion during shipping

Sandoz Inc NDC 00781-3246-02 D-0286-2022

Class I · High risk Completed Oct 12, 2021

Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC…

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

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals D-0092-2022

Class I · High risk Completed Aug 18, 2021

X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2

Reason Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.

Phe Inc D-0819-2021

Class I · High risk Completed Oct 27, 2020

Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02…

Reason Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.

Sunstar Americas, Inc. NDC 52376-021-02 D-0103-2021

Class I · High risk Completed Jun 18, 2020