State

Michigan product recalls

20,307 recalls have nationwide distribution and so reach Michigan. 0 additional recalls listed Michigan specifically in their distribution scope.

About recalls in Michigan

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Michigan consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

13026–13050 of 20307

ModerateFDA (Drugs)·D-0797-2023·2023-06-07
Akorn Recalls Cromolyn Sodium Ophthalmic Solution Over Stability Studies
Akorn Inc. is recalling all lots of Cromolyn Sodium Ophthalmic Solution, USP 4% due to manufacturing deviations. The firm went out of business and could no longer continue required stability studies.
Product
Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0801-2023·2023-06-07
Docusate Liquid Drug Recalled Over Incomplete Stability Testing
Akorn, Inc. is recalling all lots of DOCU LIQUID (docusate sodium) after the company ceased operations and could not complete mandatory stability testing required for FDA compliance.
Product
DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0793-2023·2023-06-07
Cimetidine HCl Oral Solution Recalled Due to Manufacturing Compliance Deviations
Akorn, Inc. is recalling all lots of Cimetidine HCl Oral Solution 300mg/5mL nationwide due to CGMP deviations. The firm ceased operations and could not complete required stability studies.
Product
Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0833-2023·2023-06-07
Olopatadine HCl Eye Drops Recalled for Manufacturing Quality Deviations
Akorn, Inc. is recalling all lots of Olopatadine HCl Ophthalmic Solution, USP 0.1% eye drops due to Current Good Manufacturing Practice deviations. The manufacturer discontinued required stability studies after ceasing operations.
Product
Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0813-2023·2023-06-07
Akorn Ketorolac Eye Drops Recalled Due to Manufacturing Quality Deviations
Akorn, Inc. is recalling all lots of Ketorolac Tromethamine Ophthalmic Solution 0.5% because the manufacturer went out of business and cannot complete required stability testing.
Product
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0842-2023·2023-06-07
Ropivacaine Hydrochloride Injection Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Ropivacaine Hydrochloride Injection USP 0.5% nationwide due to incomplete stability studies. The manufacturer ceased operations and could not continue required FDA testing.
Product
Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0824-2023·2023-06-07
Akorn Lidocaine Oral Solution Recalled Due to Manufacturing Compliance Deviations
Akorn Operating Company is recalling all lots of Lidocaine Hydrochloride Oral Topical Solution 2% distributed nationally because the firm ceased operations and could not complete required stability studies.
Product
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0856-2023·2023-06-07
XOPENEX Inhalation Solution Recalled Due to Manufacturing Compliance Issues
Akorn, Inc. is recalling all lots of XOPENEX (levalbuterol HCl) inhalation solution because the company went out of business and cannot continue required stability studies. The firm's manufacturing deviations affect product safety verification.
Product
XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0829-2023·2023-06-07
Moxifloxacin HCl Ophthalmic Solution Recalled Due to CGMP Compliance Deviation
Moxifloxacin HCl Ophthalmic Solution 0.5% is being recalled because manufacturer Akorn, Inc. ceased operations and cannot complete required stability studies. All lots distributed nationwide in the USA and Puerto Rico are affected.
Product
Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0787-2023·2023-06-07
Azelastine Hydrochloride Nasal Spray Recalled Due to Manufacturing Deviations
Akorn, Inc. is recalling all lots of Azelastine Hydrochloride Nasal Spray nationwide due to manufacturing process deviations. The firm ceased operations and could no longer conduct required stability studies.
Product
Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Tech Pharmacal Co., INC., Amityville, NY 11701. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0794-2023·2023-06-07
Clobetasol Propionate Cream Recalled Due to CGMP Violations and Unverified Stability
Akorn, Inc. is recalling all lots of Clobetasol Propionate Cream 0.05% nationwide because the manufacturer went out of business before completing required stability studies to verify product safety and efficacy.
Product
Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0822-2023·2023-06-07
Lidocaine Ointment USP Recalled Due to Manufacturing Process Deviations
Akorn, Inc. recalls all lots of Lidocaine Ointment USP 5% (1 1/4 oz tubes) distributed nationwide due to CGMP deviations. The manufacturer could not complete required stability studies after closing operations.
Product
Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0782-2023·2023-06-07
Acyclovir Oral Suspension Recalled for Manufacturing Practice Deviations
Akorn's Acyclovir Oral Suspension is being recalled nationwide due to manufacturing practice deviations. The firm closed and could not complete required stability studies for the medication.
Product
Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0783-2023·2023-06-07
Albuterol Sulfate Syrup Recalled for Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Albuterol Sulfate Syrup nationwide due to CGMP deviations. The firm went out of business and could not complete required stability studies to verify ongoing product safety and effectiveness.
Product
Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0796-2023·2023-06-07
Clobetasol Propionate Shampoo Recall Due to Manufacturing Compliance Issues
Akorn, Inc. is recalling all lots of Clobetasol Propionate Shampoo, 0.05% distributed nationwide after the firm closed and could not continue required stability studies.
Product
Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0806-2023·2023-06-07
FDA Recalls Granisetron HCl Injectable Drug Due to Manufacturing Compliance Failure
Akorn, Inc. recalls all lots of Granisetron HCl Injection nationwide because the manufacturer ceased operations and cannot complete required stability studies, leaving the drug's shelf-life unverified.
Product
Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only, For Intravenous Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0781-2023·2023-06-07
Acetic Acid Otic Solution recalled due to manufacturing deviations and unverified stability
Akorn is recalling all lots of Acetic Acid Otic Solution nationwide due to manufacturing practice deviations. The firm went out of business and could not complete stability studies required to verify the product remained safe and effective.
Product
Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0848-2023·2023-06-07
Akorn Antibiotic Suspension Recalled Due to CGMP Deviations and Unverified Stability
Akorn recalls all lots of Sulfamethoxazole & Trimethoprim Oral Suspension (200mg/40mg per 5mL) nationwide due to inability to complete required stability studies after the company ceased operations.
Product
Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufactured by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0799-2023·2023-06-07
Dicyclomine Hydrochloride Injectable Drug Recalled for Manufacturing Quality Deviations
Akorn, Inc. is recalling all lots of Dicyclomine Hydrochloride Injection USP nationwide due to Current Good Manufacturing Practice deviations. The firm went out of business and could not complete required stability studies.
Product
Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0844-2023·2023-06-07
Akorn Sodium Chloride Ophthalmic Ointment Recalled Due to Manufacturing Deviations
Akorn Inc. is recalling all lots of Sodium Chloride Ophthalmic Ointment 5% nationwide due to manufacturing practice deviations. The company ceased operations and could not continue stability studies required to verify the product's safety and effectiveness.
Product
Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0779-2023·2023-06-07
Akorn Atropine Sulfate Eye Drops Recalled Due to Manufacturing Compliance Failures
Akorn, Inc. is recalling all lots of Atropine Sulfate Ophthalmic Solution USP 1% because the firm went out of business and could not complete required stability studies. The product was distributed nationwide in the USA and Puerto Rico.
Product
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0791-2023·2023-06-07
Cetrorelix Acetate Injectable Recalled Due to Manufacturing Deviations
Akorn, Inc. recalls all lots of Cetrorelix Acetate for Injection due to manufacturing process deviations. The company went out of business and could not complete required stability testing.
Product
Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for reconstitution, 1 pre-filled syringe with diluent, 1 20-gauge needle, 1 27-gauge needle, Sterile - For subcutaneous use only, Rx Only, Manufacture
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0803-2023·2023-06-07
Ferrous Sulfate Iron Supplement Drops Recalled for Manufacturing Stability Issues
All lots of Ferrous Sulfate Iron Supplement Drops are being recalled nationwide. The manufacturer went out of business and cannot complete required stability studies to verify product safety.
Product
Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0778-2023·2023-06-07
Compounded Phenylephrine Solution Recalled Due to Wrong Base Diluent
Advanced Compounding Solutions is recalling a compounded phenylephrine solution made with 5% Dextrose instead of the correct 0.9% Sodium Chloride diluent. The error affects 198 units distributed nationwide.
Product
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1664-2023·2023-06-07
VITROS Chemistry Calibrator Kit Cannot Calibrate Vancomycin Reagent
Ortho-Clinical Diagnostics is recalling 132 units of VITROS Chemistry Calibrator Kit 11 with defective Assay Data Disk versions due to inability to calibrate vancomycin reagent, delaying laboratory testing.
Product
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Che
Category
Medical Device
Distribution
Distributed nationwide