May 7, 2025DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., R
Hazard: Subpotent
May 7, 2025DrugsFDA
Cardinal Health Inc. recalls Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx O
Hazard: Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.
May 7, 2025DrugsFDA
Nubratori, Inc recalls Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per bo
Hazard: Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
May 7, 2025DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC
Hazard: cGMP Deviations
May 7, 2025DrugsFDA
Eugia US LLC recalls Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured
Hazard: Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
May 7, 2025DrugsFDA
Eugia US LLC recalls Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in
Hazard: Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
April 30, 2025DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51
Hazard: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
April 30, 2025DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe,
Hazard: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
April 30, 2025DrugsFDA
Medisca Inc. recalls Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) dru
Hazard: CGMP Deviations
April 30, 2025DrugsFDA
OurPharma LLC recalls HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake
Hazard: Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
April 30, 2025DrugsFDA
Pharmadel, LLC recalls Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel,
Hazard: cGMP deviations
April 30, 2025DrugsFDA
Pharmadel, LLC recalls Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 557
Hazard: cGMP deviations
April 30, 2025DrugsFDA
Pharmadel, LLC recalls Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distributed by: Pharmadel, New Castle, DE 19720, NDC
Hazard: cGMP deviations
April 30, 2025DrugsFDA
Pharmadel, LLC recalls Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Cast
Hazard: cGMP deviations
April 30, 2025DrugsFDA
Pharmadel, LLC recalls DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-1
Hazard: cGMP deviations
April 30, 2025DrugsFDA
Pharmadel, LLC recalls DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Ca
Hazard: cGMP deviations
April 30, 2025DrugsFDA
RemedyRepack Inc. recalls Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 157
Hazard: CGMP Deviations
April 30, 2025DrugsFDA
Lupin Pharmaceuticals Inc. recalls clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc.
Hazard: Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
April 30, 2025DrugsFDA
Apipharma recalls Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima
Hazard: CGMP Deviations
April 30, 2025DrugsFDA
Apipharma recalls Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o,
Hazard: CGMP Deviations
April 30, 2025DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, E
Hazard: Lack of Assurance of Sterility: Leaking/damaged syringes.
April 30, 2025DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewo
Hazard: Lack of Assurance of Sterility: Leaking/damaged syringes.
April 30, 2025DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Healt
Hazard: Lack of Assurance of Sterility: Leaking/damaged syringes.
April 30, 2025DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe,
Hazard: Lack of Assurance of Sterility: Leaking/damaged syringes.
April 30, 2025DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewo
Hazard: Lack of Assurance of Sterility: Leaking/damaged syringes.
April 30, 2025DrugsFDA
Amerisource Health Services LLC recalls Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics
Hazard: Lack of assurance of sterility. Bacterial contamination detected in some media fill units
April 30, 2025DrugsFDA
Amerisource Health Services LLC recalls Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics
Hazard: Lack of assurance of sterility. Bacterial contamination detected in some media fill units
April 30, 2025DrugsFDA
Amerisource Health Services LLC recalls Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limite
Hazard: Lack of assurance of sterility. Bacterial contamination detected in some media fill units
April 23, 2025DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Dist
Hazard: CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
April 23, 2025DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland
Hazard: LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.