April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fres
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fres
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, M
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD B
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD B
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 U
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Frese
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Frese
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fr
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fres
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Fresenius Kabi USA, LLC recalls 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only,
Hazard: Lack of Assurance of Sterility
April 15, 2026DrugsFDA
Cipla USA, Inc. recalls Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Phar
Hazard: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
April 15, 2026DrugsFDA
Cipla USA, Inc. recalls Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only,
Hazard: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
April 8, 2026DrugsFDA
Amneal Pharmaceuticals, LLC recalls Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags
Hazard: Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
April 8, 2026DrugsFDA
Appco Pharma LLC recalls Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,
Hazard: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
April 8, 2026DrugsFDA
Appco Pharma LLC recalls Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,
Hazard: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
April 8, 2026DrugsFDA
Appco Pharma LLC recalls Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,
Hazard: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
April 8, 2026DrugsFDA
K.C. Pharmaceuticals, Inc recalls Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEAD
Hazard: Lack of Assurance of Sterility
April 8, 2026DrugsFDA
K.C. Pharmaceuticals, Inc recalls STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bot
Hazard: Lack of Assurance of Sterility
April 8, 2026DrugsFDA
K.C. Pharmaceuticals, Inc recalls Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) Industria
Hazard: Lack of Assurance of Sterility
April 8, 2026DrugsFDA
K.C. Pharmaceuticals, Inc recalls Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Dro
Hazard: Lack of Assurance of Sterility
April 8, 2026DrugsFDA
K.C. Pharmaceuticals, Inc recalls Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER
Hazard: Lack of Assurance of Sterility
April 8, 2026DrugsFDA
K.C. Pharmaceuticals, Inc recalls Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a
Hazard: Lack of Assurance of Sterility
April 8, 2026DrugsFDA
K.C. Pharmaceuticals, Inc recalls EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 m
Hazard: Lack of Assurance of Sterility
April 8, 2026DrugsFDA
K.C. Pharmaceuticals, Inc recalls Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROU
Hazard: Lack of Assurance of Sterility
April 8, 2026DrugsFDA
Amneal Pharmaceuticals, LLC recalls traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Lt
Hazard: Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
April 1, 2026DrugsFDA
Amerisource Health Services LLC recalls Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( N
Hazard: Failed tablet specifications.
April 1, 2026DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx onl
Hazard: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.