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Michigan FDA Recalls — Food, Drug, and Medical Device (Past 90 Days)

Source: U.S. Food and Drug Administration (FDA) · openFDA Enforcement API · trailing 90-day window
65
Total active
25
Food
20
Drug
20
Medical Device
What "class" means

The FDA assigns every recall one of three classes based on the severity of harm if a person uses the product:

Class I
Reasonable probability of serious adverse health consequences or death. Stop using immediately and follow return instructions.
Class II
Use may cause temporary or medically reversible adverse effects. Probability of serious harm is remote.
Class III
Not likely to cause adverse health effects — usually quality, labeling, or minor purity issues.

🥗 Food Recalls

25 active in the past 90 days · FDA Food & Cosmetic Enforcement
Jun 2, 2026
H-0938-2026
MMB of Louisiana Pasteurized Donor Human Milk, Volume: 3 oz, Cal/Oz: 19, 0.9 g/dL Protein,
Recalled by Mothers' Milk Bank of Louisiana at Ochsner Baptist
Potential physical contamination: dark spot was noticed on the bottom of container.
CLASS III Voluntary: Firm initiated
FDA record ↗
May 21, 2026
H-0942-2026
1. TNVitamins Ultrapotent Complete Green Superfood Moringa Capsules (120 count) 2. Docto
Recalled by Total Nutrition Inc
Product may be contaminated with Salmonella.
CLASS I Voluntary: Firm initiated
FDA record ↗
May 21, 2026
H-0948-2026
001165: Standard Pasteurized Donor Human Milk; 100 mL bottles 001198: Pediatric Pasteurize
Recalled by University of California Health Milk Bank
Product is potentially contaminated with foreign material (plastic particles).
CLASS II Voluntary: Firm initiated
FDA record ↗
May 19, 2026
H-0903-2026
Birch Benders Sweet Potato Pancake and Waffle Mix 12oz bag, UPC 8 1000156076 8, 6 bags per
Recalled by Hometown Food Company
Undeclared egg
CLASS I Voluntary: Firm initiated
FDA record ↗
May 18, 2026
H-0913-2026
ESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL. (413 ML), 64
Recalled by Refresqueria Estrella Inc.
Undeclared FD&C Red 40
CLASS III Voluntary: Firm initiated
FDA record ↗
May 18, 2026
H-0912-2026
Farm Rich Pizza Cheese Crunchers
Recalled by Rich Products Corp
May contain metal pieces
CLASS II Voluntary: Firm initiated
FDA record ↗
May 18, 2026
H-0941-2026
Individual Unit Label (both lid and front of cup): Whole Foods Market Kitchens Minestrone
Recalled by Kettle Cuisine, LLC
Contains undeclared allergen (shrimp).
CLASS I Voluntary: Firm initiated
FDA record ↗
May 17, 2026
H-0906-2026
Raw Shelled Peanuts (Runner Type) 2,200 lb. Poly Tote Bags and 50kg Poly Bags
Recalled by Wilco Peanut Co
Undeclared Tree Nut Allergen
CLASS I Voluntary: Firm initiated
FDA record ↗
May 14, 2026
H-0943-2026
DRAGONFLY Thai Ginger Powder Net Weight: 4.37 oz (125 g) PRODUCT OF THAILAND Packed for:
Recalled by U.S. Tov, Inc. dba U.S. Trading Company
Potential contamination with lead.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 13, 2026
H-0898-2026
Enoki Mushroom, Net Weight 150g; Product of Korea; Distributed by IQ Produce UPC: 8809316
Recalled by IQ PRODUCE, LLC
Imported Enoki Mushrooms samples collected by Florida Department of Health tested positive for Listeria Monocytogenes.
CLASS I Voluntary: Firm initiated
FDA record ↗
May 12, 2026
H-0899-2026
Hellas Meze Golden Smoked Whole Herring
Recalled by Terra Medi LLC
Un-eviscerated fish may be contaminated with clostridium botulinum
CLASS I Voluntary: Firm initiated
FDA record ↗
May 11, 2026
H-0895-2026
STRAUS FAMILY CREAMERY Cookie Dough ORGANIC SUPER PREMIUM ICE CREAM ONE PINT (473mL) Prod
Recalled by Straus Family Creamery
Potential contamination with foreign objects (metal pieces).
CLASS II Voluntary: Firm initiated
FDA record ↗
May 11, 2026
H-0897-2026
STRAUS FAMILY CREAMERY Mint Chip ORGANIC SUPER PREMIUM ICE CREAM ONE PINT (473mL) Produce
Recalled by Straus Family Creamery
Potential contamination with foreign objects (metal pieces).
CLASS II Voluntary: Firm initiated
FDA record ↗
May 11, 2026
H-0894-2026
STRAUS FAMILY CREAMERY Strawberry ORGANIC SUPER PREMIUM ICE CREAM ONE QUART (946mL) ONE PI
Recalled by Straus Family Creamery
Potential contamination with foreign objects (metal pieces).
CLASS II Voluntary: Firm initiated
FDA record ↗
May 11, 2026
H-0893-2026
STRAUS FAMILY CREAMERY Vanilla Bean ORGANIC SUPER PREMIUM ICE CREAM ONE PINT (473mL) Prod
Recalled by Straus Family Creamery
Potential contamination with foreign objects (metal pieces).
CLASS II Voluntary: Firm initiated
FDA record ↗
May 11, 2026
H-0896-2026
STRAUS FAMILY CREAMERY Dutch Chocolate ORGANIC SUPER PREMIUM ICE CREAM ONE QUART (946mL)
Recalled by Straus Family Creamery
Potential contamination with foreign objects (metal pieces).
CLASS II Voluntary: Firm initiated
FDA record ↗
May 10, 2026
H-0939-2026
HH Fresh Trading Corp. (branded) ENOKI MUSHROOM; Premium Quality; Net WT/ Poids Net 150g(5
Recalled by HH FRESH TRADING CORP
Imported Enoki Mushrooms tested positive for Listeria Monocytogenes.
CLASS I Voluntary: Firm initiated
FDA record ↗
May 7, 2026
H-0914-2026
Lunds & Byerly's Curry Powder Sweet
Recalled by J and J Bunting, Inc
Sesame Seeds White were labeled as Curry Powder Sweet.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 7, 2026
H-0854-2026
Fly By Jing (branded) Creamy Sesame Noodles; 3.8 oz packets. Sold in single and 4 packs. S
Recalled by Fly By Jing Inc.
Possible cross-contamination resulting in undeclared allergen ingredient (Peanut)
CLASS II Voluntary: Firm initiated
FDA record ↗
May 6, 2026
H-0809-2026
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement, Net Wt. 8 FL Oz (237mL) Ambe
Recalled by Llorens Pharmaceuticals International Division, Inc.
Foreign object: black particulate matter
CLASS II Voluntary: Firm initiated
FDA record ↗
May 5, 2026
H-0908-2026
Aramark Cheese Sauce New & Improved, 25 lb., packaged in a tied poly bag and packed 2 bags
Recalled by The Coffee Connexion Co., Inc
Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination
CLASS I Voluntary: Firm initiated
FDA record ↗
May 5, 2026
H-0907-2026
1) Cheese Sauce Mix, 25.5 oz., packaged in a sealed poly bag and packed 12 bags per case,
Recalled by The Coffee Connexion Co., Inc
Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination
CLASS I Voluntary: Firm initiated
FDA record ↗
May 5, 2026
ANGEL branded STRAWBERRY SOFT-SERVE powder; 10- 2-pound bag/case NO UPC.
Recalled by SKS Copack
Products may potentially be contaminated with Salmonella.
CLASS I Voluntary: Firm initiated
May 5, 2026
H-0909-2026
Alfredo Sauce, 3 lb. 7 oz., packaged in a sealed poly bag and packed 12 bags per case, UPC
Recalled by The Coffee Connexion Co., Inc
Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination
CLASS I Voluntary: Firm initiated
FDA record ↗
May 5, 2026
N/A
NEURO NOURISH dietary supplement; 6-IN-1 PREBIOTIC, PROBIOTIC, VITAMIN, MINERAL, FATTY ACI
Recalled by SENSORY SUPPLEMENT LLC
Premature lipid oxidation causing quality issue potentially causing product to have an off odor and bitter taste.
CLASS — Voluntary: Firm initiated
FDA record ↗

💊 Drug Recalls

20 active in the past 90 days · FDA Drug Enforcement
Jun 3, 2026
D-0595-2026
Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674
Recalled by Haleon US Holdings LLC
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the pa
CLASS I Voluntary: Firm initiated
FDA record ↗
Jun 3, 2026
D-0583-2026
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-
Recalled by Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
CLASS II Voluntary: Firm initiated
FDA record ↗
Jun 3, 2026
D-0582-2026
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufacture
Recalled by Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
CLASS II Voluntary: Firm initiated
FDA record ↗
Jun 2, 2026
D-0585-2026
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Ph
Recalled by Amneal Pharmaceuticals, LLC
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue
CLASS III Voluntary: Firm initiated
FDA record ↗
May 31, 2026
D-0597-2026
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only,
Recalled by Ascend Laboratories, LLC
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution
CLASS II Voluntary: Firm initiated
FDA record ↗
May 31, 2026
N/A
BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xyli
Recalled by BEEKEEPER'S NATURALS USA INC.
Microbial Contamination of Non-Sterile Products
CLASS — Voluntary: Firm initiated
FDA record ↗
May 28, 2026
D-0607-2026
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single
Recalled by SUN PHARMACEUTICAL INDUSTRIES INC
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for bla
CLASS II Voluntary: Firm initiated
FDA record ↗
May 28, 2026
D-0587-2026
GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Ma
Recalled by Golden State Medical Supply Inc.
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (lo
CLASS II Voluntary: Firm initiated
FDA record ↗
May 27, 2026
D-0558-2026
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle,
Recalled by Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 27, 2026
D-0572-2026
HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED
Recalled by Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 27, 2026
D-0565-2026
CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Di
Recalled by Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 27, 2026
D-0571-2026
HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED
Recalled by Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 27, 2026
D-0579-2026
TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TAB
Recalled by Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 27, 2026
D-0575-2026
GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets,
Recalled by Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 27, 2026
D-0559-2026
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle, H
Recalled by Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 27, 2026
D-0567-2026
DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets,
Recalled by Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 27, 2026
D-0566-2026
CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, D
Recalled by Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 27, 2026
D-0577-2026
EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, D
Recalled by Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 27, 2026
D-0574-2026
GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets,
Recalled by Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 27, 2026
D-0576-2026
EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DI
Recalled by Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
CLASS II Voluntary: Firm initiated
FDA record ↗

🩺 Medical Device Recalls

20 active in the past 90 days · FDA Device Enforcement
May 26, 2026
Z-2400-2026
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Recalled by Inter-Med Llc
Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifie
CLASS II Voluntary: Firm initiated
FDA record ↗
May 20, 2026
Z-2406-2026
MOSAIQ Oncology Information System
Recalled by Elekta, Inc.
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 17, 2026
Z-2305-2026
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx
Recalled by DeRoyal Industries Inc
Sterile wound dressing, lacks sterility assurance
CLASS II Voluntary: Firm initiated
FDA record ↗
May 12, 2026
Z-2240-2026
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, elec
Recalled by Medtronic Neuromodulation
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 12, 2026
Z-2241-2026
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, elec
Recalled by Medtronic Neuromodulation
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 11, 2026
Z-2321-2026
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G,
Recalled by Fresenius Medical Care Holdings, Inc.
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to noti
CLASS II Voluntary: Firm initiated
FDA record ↗
May 11, 2026
Z-2413-2026
Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca A
Recalled by Boston Scientific Corporation
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due t
CLASS II Voluntary: Firm initiated
FDA record ↗
May 11, 2026
Z-2405-2026
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 softwar
Recalled by Abbott Medical
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successful
CLASS II Voluntary: Firm initiated
FDA record ↗
May 10, 2026
Z-2355-2026
NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name
Recalled by In2bones USA, LLC
Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 6, 2026
Z-2401-2026
Bicarby Dialysate; Model number: RFP-400-G;
Recalled by Fresenius Medical Care Holdings, Inc.
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and
CLASS II Voluntary: Firm initiated
FDA record ↗
May 6, 2026
Z-2208-2026
Atlan A350XL. Model Number: 8621600. anesthesia workstation
Recalled by Draeger, Inc.
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of
CLASS I Voluntary: Firm initiated
FDA record ↗
May 6, 2026
Z-2398-2026
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme
Recalled by Siemens Healthcare Diagnostics, Inc.
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (
CLASS II Voluntary: Firm initiated
FDA record ↗
May 6, 2026
Z-2207-2026
Atlan A350. Model Number: 8211500. anesthesia workstation
Recalled by Draeger, Inc.
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of
CLASS I Voluntary: Firm initiated
FDA record ↗
May 5, 2026
Z-2277-2026
Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan
Recalled by B Braun Medical Inc
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine,
CLASS I Voluntary: Firm initiated
FDA record ↗
May 5, 2026
Z-2282-2026
Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Was
Recalled by Stryker Corporation
It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and
CLASS II Voluntary: Firm initiated
FDA record ↗
May 5, 2026
Z-2276-2026
Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINA
Recalled by B Braun Medical Inc
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine,
CLASS I Voluntary: Firm initiated
FDA record ↗
May 5, 2026
Z-2223-2026
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Recalled by Fresenius Kabi USA, LLC
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a
CLASS I Voluntary: Firm initiated
FDA record ↗
May 5, 2026
Z-2224-2026
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Recalled by Fresenius Kabi USA, LLC
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause d
CLASS I Voluntary: Firm initiated
FDA record ↗
May 5, 2026
Z-2278-2026
Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description
Recalled by B Braun Medical Inc
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine,
CLASS I Voluntary: Firm initiated
FDA record ↗
May 3, 2026
Z-2353-2026
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Ver
Recalled by Micromed S.p.A.
Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four di
CLASS II Voluntary: Firm initiated
FDA record ↗

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