Drug recalls

FDA recalls of prescription and over-the-counter drugs.

51–65 of 65

ModerateFDA (Drugs)·D-0501-2026·2026-05-06
Similasan iVIZIA Sterile Lubricant Eye Drops Recall Due to Sterility Assurance
Thea Pharma, Inc. is recalling Similasan iVIZIA Sterile Lubricant Eye Drops due to the lack of assurance of sterility caused by manufacturing deviations found by the FDA.
Product
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0507-2026·2026-05-06
Ketamine Hydrochloride Injectable Solution Recalled for cGMP Deviations
Wells Pharma of Houston LLC is recalling 4,975 syringes of Ketamine Hydrochloride Injectable Solution (50 mg/mL) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.
Product
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0526-2026·2026-05-06
Alendronate Sodium Oral Solution Recalled for Out-of-Specification Assay Results
Hikma Pharmaceuticals USA Inc. is recalling Alendronate Sodium Oral Solution 70 mg/75 mL due to out-of-specification assay results found in a limited number of bottles. The affected lot (AC2040A) was distributed nationwide.
Product
ALENDRONATE SODIUM — ALENDRONATE SODIUM (ALENDRONATE SODIUM)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0494-2026·2026-05-06
Levocarnitine Injection USP Missing Label Recall
American Regent, Inc. is recalling Levocarnitine Injection USP (1 g/5 mL) due to missing labeling on certain lots. The affected product was distributed nationwide.
Product
LEVOCARNITINE — LEVOCARNITINE (LEVOCARNITINE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0509-2026·2026-05-06
CVS Lidocaine Wound Gel recalled for failed pH specifications
CVS Lidocaine Wound Gel is being recalled because it failed pH specifications. The affected product is distributed nationwide.
Product
Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0497-2026·2026-04-29
Sodium Chloride for Irrigation Lacks Sterility Assurance
B. Braun Medical Inc. is recalling sodium chloride for irrigation solution (3000 mL bags) due to lack of assurance of sterility and potential leakage from the diaphragm port. Affected lots distributed nationwide have expiration dates through May 31, 2028.
Product
SODIUM CHLORIDE FOR IRRIGATION — SODIUM CHLORIDE FOR IRRIGATION (SODIUM CHLORIDE FOR IRRIGATION)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0495-2026·2026-04-29
Sterile Water for Injection bags recalled due to sterility concerns
B. Braun Medical Inc. is recalling Sterile Water for Injection USP 3000 mL bags (24,928 units) distributed nationwide due to lack of assurance of sterility and potential leakage from the diaphragm port.
Product
STERILE WATER — STERILE WATER (WATER)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0496-2026·2026-04-29
Dextrose Injection USP recalled due to sterility assurance concerns
B. Braun Medical Inc. is recalling Dextrose Injection USP 70% in 2000 mL bags nationwide due to lack of assurance of sterility and potential leakage from the diaphragm port after foil removal.
Product
DEXTROSE — DEXTROSE (DEXTROSE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0489-2026·2026-04-29
Harrow Eye FRESHKOTE Lubricant Eyedrops Sterile 10mL Recall
Harrow Eye LLC is recalling FRESHKOTE Lubricant Eyedrops because the manufacturer cannot guarantee the product remains sterile. Affected lots are 1X68 and 1X69, with an expiration date of 05/31/2027.
Product
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0486-2026·2026-04-29
Furosemide tablets recalled for presence of N-nitroso impurity
Leading Pharma, LLC is recalling Furosemide 80 mg tablets due to the presence of N-nitroso-Furosemide (NNF) above the recommended intake limit, caused by manufacturing deviations.
Product
FUROSEMIDE — FUROSEMIDE (FUROSEMIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0498-2026·2026-04-29
Lactated Ringers Irrigation 3000 mL Bags Recall: Sterility Concern
B. Braun Medical Inc. is recalling Lactated Ringers Irrigation 3000 mL bags due to lack of assurance of sterility and potential leakage from the diaphragm port after foil removal.
Product
LACTATED RINGERS IRRIGATION — LACTATED RINGERS IRRIGATION (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0484-2026·2026-04-29
Pantoprazole Sodium Tablets Recalled for Discoloration Issues
Hetero Labs Limited is recalling Pantoprazole Sodium 40 mg delayed-release tablets due to discoloration—some tablets are darker than normal with lighter-colored spots. The firm received five complaints about the affected tablets.
Product
PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0493-2026·2026-04-29
Omega-3-Acid Ethyl Esters capsules recalled for failed capsule specifications
The Harvard Drug Group LLC is recalling Omega-3-Acid Ethyl Esters capsules (1 gram, 50-count cartons) due to failed capsule specifications discovered during routine stability testing.
Product
OMEGA-3-ACID ETHYL ESTERS — OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0521-2026·2026-04-29
Claravis isotretinoin 10 mg capsules recalled for out-of-specification impurity
Teva Pharmaceuticals is recalling Claravis (isotretinoin) 10 mg capsules due to failure to meet impurity specifications. The affected lots were distributed nationwide in the USA, Puerto Rico, and the Virgin Islands.
Product
CLARAVIS — CLARAVIS (ISOTRETINOIN)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0490-2026·2026-04-29
Monsel's Solution ferric subsulfate vials recalled for incorrect expiration date printing
Premier Dental Products is recalling Monsel's Solution (ferric subsulfate) 8 mL vials because the expiration date on the vial itself is printed with an extra digit (2709114 instead of 270914). The carton expiration date is correct.
Product
MONSELS SOLUTION — MONSELS SOLUTION (FERRIC SUBSULFATE)
Category
Drug
Distribution
Distributed nationwide

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