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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 8, 2026
H-0950-2026
Al Yaman Halawa Extra Pistachio 907g (31.994 oz) plastic jars, UPC 5 287000 098083, 12 ret
Recalled by GREENWORLD FOOD EXPRESS (USA) LLC
Product may be contaminated with Salmonella
CLASS I Voluntary: Firm initiated
FDA record ↗
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 ↗
Jun 1, 2026
H-1080-2026
Dried Herring Fish 7 oz.
Recalled by Prime Food Processing LLC.
Improperly eviscerated which may result in Clostridium botulinum contamination
CLASS I Voluntary: Firm initiated
FDA record ↗
May 28, 2026
H-1095-2026
Motor City Pizza Co. 5 Cheese Bread Single retail pack; 22.43 oz. (1 lb. 6.4 oz.) 636g UPC
Recalled by Champion Foods, LLC
potential salmonella contamination
CLASS II Voluntary: Firm initiated
FDA record ↗
May 27, 2026
H-1075-2026
azuma foods TAKO WASABI Seasoned Octopus with Wasabi PERISHABLE/KEEP FROZEN PRODUCT OF J
Recalled by Azuma Foods International Inc USA
Undeclared fish.
CLASS I Voluntary: Firm initiated
FDA record ↗
May 26, 2026
H-1111-2026
Roast beef and cheddar closed face sandwich packed in clear plastic wrap with a green adhe
Recalled by Produce Innovations
Incorrect Product Label; Roast Beef and Swiss closed face sub sandwich labeled as Turkey and Cheddar closed face sub san
CLASS III Voluntary: Firm initiated
FDA record ↗
May 21, 2026
H-1133-2026
boichik bagles Pumpernickel Mix Bagels 6 pre-sliced bagels NET WT 26.5 OZ (1.66 LB) 750g
Recalled by Boichik Bagels, Inc.
Undeclared allergen, sesame.
CLASS II 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-1131-2026
boichik bagels Whitefish Salad Ingredients: Smoked whitefish, mayonnaise (soybean oil, wa
Recalled by Boichik Bagels, Inc.
Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.
CLASS II 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 21, 2026
H-1132-2026
boichik bagles Tuna Salad Ingredients: albacore tuna, mayonnaise (soybean oil, water, who
Recalled by Boichik Bagels, Inc.
Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 20, 2026
H-1110-2026
El David Gelee, Bonbons with fruits Soft & Juicy, 400g. Packaged in decorated paperboard b
Recalled by Alb-USA Enterprises Inc
Undeclared colors (FD&C Yellow 5 and FD&C Red 40).
CLASS II Voluntary: Firm initiated
FDA record ↗
May 20, 2026
H-0951-2026
Fairhope Roasting Company Cold Brew Coffee Concentrate, packaged in 1-gallon plastic jugs,
Recalled by Fairhope Roasting Company
Product requires refrigeration but the label is missing a "Keep Refrigerated" statement
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-1077-2026
Dairy House Ingredient Systems Vanilla Dairy Powder, 50 lb box
Recalled by International Food Products Corporation
Potential for Salmonella
CLASS II Voluntary: Firm initiated
FDA record ↗
May 17, 2026
H-1076-2026
Legacy Tex Dressing Stabilizer Blend #7604-50, 50lb bags
Recalled by International Food Products Corporation
Product tested positive for Salmonella
CLASS II Voluntary: Firm initiated
FDA record ↗
May 17, 2026
H-1078-2026
Dairy House Ingredient Systems Strawberry Dairy Powder 05#5072-50, 50 lb bags
Recalled by International Food Products Corporation
Potential for Salmonella
CLASS II 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 14, 2026
H-0949-2026
Great Value Hawaiian Roll 4pk, Item # F63384. Product is perishable dinner roll ready to e
Recalled by United States Bakery
Firm observed oily and sticky substance on direct food contact surface packaging of finished product.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 13, 2026
H-0952-2026
Salt
Recalled by United Salt Corp
Plain salt was labeled as iodized and iodized salt was labeled as plain.
CLASS III 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 ↗

💊 Drug Recalls

20 active in the past 90 days · FDA Drug Enforcement
Jun 21, 2026
D-0617-2026
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps
Recalled by Direct Rx
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
CLASS II Voluntary: Firm initiated
FDA record ↗
Jun 16, 2026
D-0628-2026
Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries
Recalled by SUN PHARMACEUTICAL INDUSTRIES INC
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablet
CLASS II Voluntary: Firm initiated
FDA record ↗
Jun 15, 2026
D-0609-2026
Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), R
Recalled by The Harvard Drug Group LLC
Subpotent Drug
CLASS II Voluntary: Firm initiated
FDA record ↗
Jun 11, 2026
D-0596-2026
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx O
Recalled by Par Health USA, LLC
Crystallization; identified as Buprenorphine free base
CLASS II Voluntary: Firm initiated
FDA record ↗
Jun 4, 2026
D-0610-2026
Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured
Recalled by Inventia Healthcare Limited
Failed Dissolution Specifications
CLASS II Voluntary: Firm initiated
FDA record ↗
Jun 3, 2026
D-0626-2026
Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd
Recalled by Annora Pharma Private Limited
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamid
CLASS II Voluntary: Firm initiated
FDA record ↗
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-0615-2026
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks
Recalled by Amgen, Inc.
Presence of Foreign Substance.
CLASS II Voluntary: Firm initiated
FDA record ↗
Jun 3, 2026
D-0612-2026
Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99),
Recalled by Amgen, Inc.
Presence of Foreign Substance.
CLASS II Voluntary: Firm initiated
FDA record ↗
Jun 3, 2026
D-0614-2026
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One
Recalled by Amgen, Inc.
CGMP Deviations
CLASS II Voluntary: Firm initiated
FDA record ↗
Jun 3, 2026
D-0627-2026
Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pik
Recalled by Elevate Oral Care
sub potency
CLASS II 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 3, 2026
D-0616-2026
Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One
Recalled by Amgen, Inc.
CGMP Deviations
CLASS II Voluntary: Firm initiated
FDA record ↗
Jun 3, 2026
D-0613-2026
Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One
Recalled by Amgen, Inc.
CGMP Deviations
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 ↗
Jun 1, 2026
D-0640-2026
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield L
Recalled by Dabur India Limited
CGMP Deviations; deficiencies observed during FDA inspection
CLASS II Voluntary: Firm initiated
FDA record ↗
Jun 1, 2026
D-0633-2026
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate
Recalled by Dabur India Limited
CGMP Deviations; deficiencies observed during FDA inspection
CLASS II Voluntary: Firm initiated
FDA record ↗
Jun 1, 2026
D-0641-2026
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin
Recalled by Dabur India Limited
CGMP Deviations; deficiencies observed during FDA inspection
CLASS II Voluntary: Firm initiated
FDA record ↗
Jun 1, 2026
D-0630-2026
Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomyci
Recalled by Dabur India Limited
CGMP Deviations; deficiencies observed during FDA inspection
CLASS II Voluntary: Firm initiated
FDA record ↗

🩺 Medical Device Recalls

20 active in the past 90 days · FDA Device Enforcement
Jun 4, 2026
Z-2579-2026
Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following syste
Recalled by Philips North America Llc
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the eq
CLASS II Voluntary: Firm initiated
FDA record ↗
May 27, 2026
Z-2532-2026
Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Scr
Recalled by Acumed LLC
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 26, 2026
Z-2574-2026
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Ret
Recalled by Dexcom, Inc.
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the des
CLASS II Voluntary: Firm initiated
FDA record ↗
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 25, 2026
Z-2522-2026
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Recalled by Philips North America Llc
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing an
CLASS II Voluntary: Firm initiated
FDA record ↗
May 25, 2026
Z-2523-2026
Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
Recalled by Philips North America Llc
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing an
CLASS II Voluntary: Firm initiated
FDA record ↗
May 21, 2026
Z-2601-2026
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro
Recalled by Abiomed, Inc.
Potential for thrombus formation during prolonged use of the introducer.
CLASS I Voluntary: Firm initiated
FDA record ↗
May 21, 2026
Z-2600-2026
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code:
Recalled by Abiomed, Inc.
Potential for thrombus formation during prolonged use of the introducer.
CLASS I Voluntary: Firm initiated
FDA record ↗
May 21, 2026
Z-2599-2026
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code:
Recalled by Abiomed, Inc.
Potential for thrombus formation during prolonged use of the introducer.
CLASS I Voluntary: Firm initiated
FDA record ↗
May 21, 2026
Z-2602-2026
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro
Recalled by Abiomed, Inc.
Potential for thrombus formation during prolonged use of the introducer.
CLASS I 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 20, 2026
Z-2514-2026
BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stop
Recalled by BD SWITZERLAND SARL
Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue
CLASS II Voluntary: Firm initiated
FDA record ↗
May 19, 2026
Z-2528-2026
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Cat
Recalled by Zimmer, Inc.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to
CLASS II Voluntary: Firm initiated
FDA record ↗
May 19, 2026
Z-2531-2026
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 1100
Recalled by Zimmer, Inc.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to
CLASS II Voluntary: Firm initiated
FDA record ↗
May 19, 2026
Z-2530-2026
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 11004
Recalled by Zimmer, Inc.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to
CLASS II Voluntary: Firm initiated
FDA record ↗
May 19, 2026
Z-2527-2026
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catal
Recalled by Zimmer, Inc.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to
CLASS II Voluntary: Firm initiated
FDA record ↗
May 19, 2026
Z-2529-2026
Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Cata
Recalled by Zimmer, Inc.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to
CLASS II Voluntary: Firm initiated
FDA record ↗
May 18, 2026
Z-2451-2026
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Recalled by Medtronic Navigation, Inc.-Boxborough
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
CLASS II Voluntary: Firm initiated
FDA record ↗
May 18, 2026
Z-2461-2026
TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
Recalled by Howmedica Osteonics Corp.
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Tria
CLASS II Voluntary: Firm initiated
FDA record ↗
May 18, 2026
Z-2462-2026
TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
Recalled by Howmedica Osteonics Corp.
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Tria
CLASS II Voluntary: Firm initiated
FDA record ↗

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