Aisle 2 · U.S. Food and Drug Administration
The last 60 days of FDA recall records that could reach a Garfield Heights home.
8 more records list no distribution that could reach Ohio (Ohio, nationwide, U.S.-wide or online), or none at all. Show all.
If you take a recalled medicine, ask your pharmacist or doctor before you stop it. Many drug recalls are for one lot only.
Houston Rx LLC
Why Lack of assurance of sterility.
Zydus Pharmaceuticals (USA) Inc
Why Failed Impurities/Degradation Specifications.
American Health Packaging
Why Presence of Foreign Tablets/Capsules
Teva Pharmaceuticals USA, Inc
Why Presence of Foreign Tablets/Capsules
Houston Rx LLC
Why Lack of process control
Apothecary Pharma LLC
Why Lack of Assurance of Sterility
K.C. Pharmaceuticals, Inc.
Why Lack of Assurance of Sterility
Carolina Infusion, LLC
Why Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Carolina Infusion, LLC
Why Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Carolina Infusion, LLC
Why Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
K.C. Pharmaceuticals, Inc.
Why Lack of Assurance of Sterility
SUN PHARMACEUTICAL INDUSTRIES INC
Why Failed Impurities/Degradation Specifications
Carolina Infusion, LLC
Why Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
K.C. Pharmaceuticals, Inc.
Why Lack of Assurance of Sterility
Carolina Infusion, LLC
Why Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Carolina Infusion, LLC
Why Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
K.C. Pharmaceuticals, Inc.
Why Lack of Assurance of Sterility
SUN PHARMACEUTICAL INDUSTRIES INC
Why Failed Impurities/Degradation Specifications
Carolina Infusion, LLC
Why Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
K.C. Pharmaceuticals, Inc.
Why Lack of Assurance of Sterility
Carolina Infusion, LLC
Why Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
SUN PHARMACEUTICAL INDUSTRIES INC
Why Failed Impurities/Degradation Specifications
Carolina Infusion, LLC
Why Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Preferred Pharmaceuticals, Inc.
Why Failed Content Uniformity Specifications
Apothecary Pharma LLC
Why Lack of Assurance of Sterility
Carolina Infusion, LLC
Why Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
K.C. Pharmaceuticals, Inc.
Why Lack of Assurance of Sterility
J&J INNOVATIVE MEDICINE
Why Presence of particulate matter.
Carolina Infusion, LLC
Why Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Cipla USA, Inc.
Why Failed Impurities/Degradation Specifications
K.C. Pharmaceuticals, Inc.
Why Lack of Assurance of Sterility
Carolina Infusion, LLC
Why Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Carolina Infusion, LLC
Why Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Carolina Infusion, LLC
Why Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Carolina Infusion, LLC
Why Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Carolina Infusion, LLC
Why Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
K.C. Pharmaceuticals, Inc.
Why Lack of Assurance of Sterility
Ajanta Pharma USA Inc
Why Failed Dissolution Specifications: below specification
Par Health USA, LLC
Why Crystallization
Apotex Corp.
Why Failed dissolution specifications.
TerSera Therapeutics LLC
Why Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.
Amneal Pharmaceuticals, LLC
Why Defective Container; packets were found to be either empty or partially full.
Sterling Pharmaceutical Services LLC
Why Lack of Assurance of Sterility
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Why Lack of Assurance of Sterility
Sterling Pharmaceutical Services LLC
Why Lack of Assurance of Sterility
Sterling Pharmaceutical Services LLC
Why Lack of Assurance of Sterility
Macleods Pharmaceuticals Limited
Why Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Amneal Pharmaceuticals of New York, LLC
Why Defective Delivery System: Possibility of no medication in the prefilled pen.
Sterling Pharmaceutical Services LLC
Why Lack of Assurance of Sterility
Sterling Pharmaceutical Services LLC
Why Lack of Assurance of Sterility
Sterling Pharmaceutical Services LLC
Why Lack of Assurance of Sterility
Sterling Pharmaceutical Services LLC
Why Lack of Assurance of Sterility
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Why Lack of Assurance of Sterility
Sterling Pharmaceutical Services LLC
Why Lack of Assurance of Sterility
Sterling Pharmaceutical Services LLC
Why Lack of Assurance of Sterility
Pfizer
Why Lack of Assurance of Sterility
Inventia Healthcare Limited
Why Failed Dissolution Specifications
SUN PHARMA /TARO
Why Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Safecor Health, LLC
Why Failed Stability Specifications
Safecor Health, LLC
Why Failed Stability Specifications
Safecor Health, LLC
Why Failed Stability Specifications
VITRUVIAS THERAPEUTICS INC
Why Superpotent Drug
Safecor Health, LLC
Why Failed Stability Specifications
Safecor Health, LLC
Why Failed Stability Specifications
Safecor Health, LLC
Why Failed Stability Specifications
B BRAUN MEDICAL INC
Why Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
Baxter Healthcare Corporation
Why Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Ajanta Pharma USA Inc
Why Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0…
American Regent, Inc.
Why Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
ImprimisRx NJ LLC
Why Subpotent Drug
OurPharma LLC
Why Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
Golden State Medical Supply Inc.
Why Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
Mylan Pharmaceuticals Inc
Why Failed Dissolution Specifications
Baxter Healthcare Corporation
Why CGMP Deviations
Baxter Healthcare Corporation
Why CGMP Deviations
Baxter Healthcare Corporation
Why CGMP Deviations
Mylan Pharmaceuticals Inc
Why Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Sage Products, LLC
Why Cross Contamination with Other Products
Baxter Healthcare Corporation
Why CGMP Deviations
Baxter Healthcare Corporation
Why CGMP Deviations
Baxter Healthcare Corporation
Why CGMP Deviations
Bionpharma Inc.
Why Presence of Foreign Tablets/Capsules
Baxter Healthcare Corporation
Why CGMP Deviations
Baxter Healthcare Corporation
Why CGMP Deviations
Allies Group Inc.
Why Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Baxter Healthcare Corporation
Why CGMP Deviations
Allies Group Inc.
Why Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Baxter Healthcare Corporation
Why CGMP Deviations
Baxter Healthcare Corporation
Why CGMP Deviations
Baxter Healthcare Corporation
Why CGMP Deviations
Baxter Healthcare Corporation
Why CGMP Deviations
Allies Group Inc.
Why Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Allies Group Inc.
Why Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Baxter Healthcare Corporation
Why Presence of particulate matter: Particulates identified as fiberglass
Teva Pharmaceuticals USA, Inc
Why Presence of Foreign Tablets/Capsules
American Health Packaging
Why Labeling: Label Mix-up
Supernus Pharmaceuticals, Inc.
Why Failed dissolution specifications.
Baxter Healthcare Corporation
Why CGMP Deviations
OPTIMAL BALANCE PHARMACY
Why Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Baxter Healthcare Corporation
Why CGMP Deviations
Baxter Healthcare Corporation
Why CGMP Deviations
Baxter Healthcare Corporation
Why CGMP Deviations
Apotex Corp.
Why Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
ACCORD HEALTHCARE, INC.
Why Subpotent Drug
ACCORD HEALTHCARE, INC.
Why Subpotent Drug
ACCORD HEALTHCARE, INC.
Why Subpotent Drug
B BRAUN MEDICAL INC
Why Presence of Particulate matter.
Fresenius Kabi USA, LLC
Why Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
ACCORD HEALTHCARE, INC.
Why Subpotent Drug
Church & Dwight Co., Inc.
Why CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
ACCORD HEALTHCARE, INC.
Why Subpotent Drug
Mallinckrodt Hospital Products Inc.
Why Presence of particulate matter: glass and stopper piece
ACCORD HEALTHCARE, INC.
Why Subpotent Drug
ACCORD HEALTHCARE, INC.
Why Subpotent Drug
Lupin Pharmaceuticals Inc.
Why Failed content uniformity specifications.
ACCORD HEALTHCARE, INC.
Why Subpotent Drug
ACCORD HEALTHCARE, INC.
Why Subpotent Drug
ACCORD HEALTHCARE, INC.
Why Subpotent Drug
ACCORD HEALTHCARE, INC.
Why Subpotent Drug
Hikma Pharmaceuticals USA INC.
Why Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
ACCORD HEALTHCARE, INC.
Why Subpotent Drug