September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd.,
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B
Hazard: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
September 17, 2025DrugsFDA
Atlantic Management Resources Ltd. recalls Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 0158
Hazard: cGMP violations
September 17, 2025DrugsFDA
Sandoz Inc recalls Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manuf
Hazard: Temperature Abuse
September 17, 2025DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag
Hazard: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
September 17, 2025DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per
Hazard: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
September 17, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufacture
Hazard: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
September 17, 2025DrugsFDA
World Perfumes Inc. recalls Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid Antiseptic, Contains 1 fl. oz (30 ml) per
Hazard: Defective Container: broken or leaking bottles.
September 17, 2025DrugsFDA
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutica
Hazard: CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
September 17, 2025DrugsFDA
Exela Pharma Sciences LLC recalls 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx O
Hazard: Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
September 10, 2025DrugsFDA
B BRAUN MEDICAL INC recalls 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, ND
Hazard: Presence of Particulate Matter.
September 10, 2025DrugsFDA
B BRAUN MEDICAL INC recalls Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC
Hazard: Presence of Particulate Matter
September 10, 2025DrugsFDA
Amneal Pharmaceuticals, LLC recalls chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pv
Hazard: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
September 10, 2025DrugsFDA
Amneal Pharmaceuticals, LLC recalls chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals P
Hazard: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
September 10, 2025DrugsFDA
Amneal Pharmaceuticals, LLC recalls chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt
Hazard: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
September 10, 2025DrugsFDA
Amneal Pharmaceuticals, LLC recalls chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pv
Hazard: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
September 10, 2025DrugsFDA
Amneal Pharmaceuticals, LLC recalls Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, N
Hazard: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
September 10, 2025DrugsFDA
IMMUNOCORE, LLC recalls KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by
Hazard: Subpotent Drug
September 10, 2025DrugsFDA
DermaRite Industries, LLC recalls PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777
Hazard: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
September 10, 2025DrugsFDA
DermaRite Industries, LLC recalls KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Indu
Hazard: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
September 10, 2025DrugsFDA
DermaRite Industries, LLC recalls DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Sid
Hazard: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
September 10, 2025DrugsFDA
DermaRite Industries, LLC recalls DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) b
Hazard: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
September 10, 2025DrugsFDA
Boothwyn Pharmacy LLC recalls Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy
Hazard: Subpotent Drug
September 10, 2025DrugsFDA
Boothwyn Pharmacy LLC recalls Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy
Hazard: Subpotent Drug
September 10, 2025DrugsFDA
Boothwyn Pharmacy LLC recalls Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496
Hazard: Subpotent Drug
September 10, 2025DrugsFDA
Boothwyn Pharmacy LLC recalls Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
Hazard: Subpotent Drug
September 3, 2025DrugsFDA
MEDLINE INDUSTRIES, LP - Northfield recalls RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200 NEWBERRY COMMONS, ETTERS, PA 17319, NDC 11
Hazard: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.