Every food and medication enforcement action the FDA has published in the last six months. No account needed — this is public record, made readable.
632 ENFORCEMENT ACTIONS · CLASS I MEANS A REASONABLE PROBABILITY OF SERIOUS HARM
Undeclared sesame seed ingredient in hamburger buns.
Sunflour Bakery Hamburger Bun, 18oz plastic bag containing 6 buns. UPC- 832971001522 — Distribution: Product was distributed to one local retail consignee in the Orange County area. — Lots/codes: Expiration date: 02/24/2026 — Status: Ongoing (voluntary: firm initiated)
H-0603-2026 · 1 bag
Defective container; inadequately sealed blister packaging.
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06. — Distribution: Nationwide US. — Lots/codes: Lot # N02640, Exp Date: 08/2027 — Status: Ongoing (voluntary: firm initiated)
D-0383-2026 · 8892 cartons
Foreign plastic material discovered on fill line.
Wawa Reduced Fat Milk 2% 16 oz (Pint) — Distribution: The recalled product was distributed to the following States: NJ,MD, DE, PA — Lots/codes: UPC: 0072619101438 — Status: Terminated (voluntary: firm initiated)
H-0585-2026 · 5456 units total
Foreign plastic material discovered on fill line.
Wawa Double Dutch Chocolate Milk ,16 oz (Pint) Plastic bottle Store Refrigerated — Distribution: The recalled product was distributed to the following States: NJ,MD, DE, PA — Lots/codes: UPC: 007261910 — Status: Terminated (voluntary: firm initiated)
H-0586-2026 · 5456 units total
Foreign plastic material discovered on fill line.
Wawa Cookies & Cream Milk 16 oz (Pint), Plastic bottle Store Refrigerated — Distribution: The recalled product was distributed to the following States: NJ,MD, DE, PA — Lots/codes: UPC: 0072619015158 — Status: Terminated (voluntary: firm initiated)
H-0587-2026 · 5456 units total
Foreign plastic material discovered on fill line.
Wawa Chocolate Low-fat Milk 16 oz , (Pint) Plastic bottle .Store Refrigerated — Distribution: The recalled product was distributed to the following States: NJ,MD, DE, PA — Lots/codes: UPC: 00726191014908 — Status: Terminated (voluntary: firm initiated)
H-0588-2026 · 5456 units total
Undeclared food colorings (Yellow 6, Blue 1, and Yellow 5) and unapproved Acid Red 14.
KLG, Kesar Mukhwas, perishable, 24 months, flexible plastic, 200 gm, 818812022208, Ganesha Enterprises LLC, 5200 Sigstrom Drive, Carson City, Nevada 89706 USA. — Distribution: Product was distributed in the following states: CA, GA, IL, NY, and TN. — Lots/codes: IKS265, 07/2027 — Status: Ongoing (voluntary: firm initiated)
H-0683-2026 · 347 pieces/ 200 gm pouch
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15. — Distribution: Nationwide in the USA. — Lots/codes: Lot # 49261, Exp: 04/30/27 — Status: Ongoing (voluntary: firm initiated)
D-0341-2026 · N/A
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China — Distribution: Nationwide within the United States — Lots/codes: Lot #: CP-030-20250711, Exp. Date Jul. 24th, 2027 — Status: Ongoing (voluntary: firm initiated)
D-0379-2026 · N/A
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China. — Distribution: Nationwide within the United States — Lots/codes: Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027. — Status: Ongoing (voluntary: firm initiated)
D-0380-2026 · N/A
Product Contains undeclared FD&C Yellow #5 & #6 and Red #40
XZL, Jelly Snacks, 12.68 OZ, Bag. 12 Bags per Case. — Distribution: The product was distributed to the following states : NY, RI — Lots/codes: UPC CODE 6926475202449 — Status: Terminated (voluntary: firm initiated)
H-0689-2026 · 100 Cases
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA, — Distribution: Nationwide in the USA — Lots/codes: Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027. — Status: Ongoing (voluntary: firm initiated)
D-0339-2026 · 11,407 units
Potential contamination with foreign material (Teflon fragments) from flaking cooking molds.
VERGANI 1944 MILANO 'PANDORO CLASSICO' Gluten Free, 600g NET WT. 1 LBS. 5.2 OZ., packaged in paper cartons, 6 units per case. Lot 217666, UPC 8002114019833 — Distribution: Distributed in: FL, MI, NJ — Lots/codes: Lot code: L217666 Expiration: 04/08/2026 — Status: Terminated (voluntary: firm initiated)
H-0540-2026 · 10 cases (6 units/ case) Total: 60 units (600g each)
Contaminated with Listeria monocytogenes
Wellsley Farms Farm- Raised Atlantic Salmon Net WT. 32 oz. (2 lbs.) 907 g — Distribution: MD — Lots/codes: Lot 3896 Prod June 30, 2025, BB June 30, 2027 UPC Code: 888670025963 — Status: Ongoing (voluntary: firm initiated)
H-0541-2026 · 190 cases
Defective Delivery System: Missing or duplicated needles within the injection kit
Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90. — Distribution: U.S. Nationwide — Lots/codes: Lot Q4E0112A, Exp.: 30 Apr 2027 — Status: Ongoing (voluntary: firm initiated)
D-0340-2026 · 16,477 kits
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
Frozen Cooked Medium Shrimp Peeled & Deveined, Tail Off-White Shrimp; 1 lbs retail plastic bag. UPC: 041220333035 — Distribution: Product was distributed to a single retail consignee with multiple locations (~30) in the greater Houston and Gulf Coast areas. — Lots/codes: " Lot EA14 25118, bearing a Best By date of October 28, 2026 " Lot EA14 25119, bearing a Best By date of October 29, 2026 — Status: Terminated (voluntary: firm initiated)
H-0516-2026 · 378 cases (3,780 units)
potential contamination with glass
Hortex Mieszanka 9 - skBadnikowa Spring vegetable mix with 9 ingredients, net wt 15.87oz., UPC 5 900477 018735 >, 14 units per case — Distribution: IL — Lots/codes: LOT: SoC1070925 — Status: Terminated (voluntary: firm initiated)
H-0549-2026 · 1134 units
Water was bottled under insanitary conditions.
Valley Springs 100% Natural Bottled Water packaged in the following size plastic jug with plastic caps: 1. 1 Gal Net 128 Fl oz. UPC 0 31193-00701 9. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 2. 2.5 Gallon Net (320 Fl oz./9.4L). UPC 0 31193-01501 4. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 3. Infant Water, 1 Gal Net, 128 FL. Oz. Not sterile. Use as directed by physician or by labeling directions for use of infant formula. UPC 0 31193-01401 7. 4. Daisy's Doggy Water, 1 Gal Net, 128 FL. Oz. 100% Pure Water. No Chlorine. UPC 0 31193-90100 3. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. Distributed by DDW LLC, 109 S. Thompson Rd., Sun Prairie, WI 53590. — Distribution: IL, WI — Lots/codes: All Codes — Status: Ongoing (voluntary: firm initiated)
H-0534-2026 · 379,868 units
Water was bottled under insanitary conditions.
Valley Springs 100% Natural Bottled Water. Fluoride Added. 1 Gal Net, 128 Fl. Oz. UPC 0 31193-01301 0. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. — Distribution: IL, WI — Lots/codes: All Codes — Status: Ongoing (voluntary: firm initiated)
H-0535-2026 · 7,840 units
Water was bottled under insanitary conditions.
Valley Springs Steamed Distilled Water. 1 Gal Net, 128 Fl. Oz. UPC 0 31193-00601 2. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. — Distribution: IL, WI — Lots/codes: All Codes — Status: Ongoing (voluntary: firm initiated)
H-0536-2026 · 263,440 units
Lack of Assurance of Sterility
acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56 — Distribution: US Nationwide. — Lots/codes: Lot # C274-000049124, Exp Date: 28-Feb-26. — Status: Ongoing (voluntary: firm initiated)
D-0333-2026 · 1057 bags
Lack of Assurance of Sterility
ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56 — Distribution: US Nationwide. — Lots/codes: Lot # C274-000047883, Exp Date: 17-Feb-26; Lot # C274-000048515, Exp Date: 22-Mar-26; Lot # C274-000048679, Exp Date: 31-Mar-26; Lot # C274-000049119, Exp Date: 19-Apr-26; Lot # C274-000049282, Exp Date: 27-Apr-26 — Status: Ongoing (voluntary: firm initiated)
D-0334-2026 · 1410 bags
Lack of Assurance of Sterility
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56. — Distribution: US Nationwide. — Lots/codes: Lot # C274-000047651, Exp Date: 7-Feb-26; Lot # C274-000048671, Exp Date: 30-Mar-26; Lot # C274-000048828, Exp Date: 7-Apr-26; Lot # C274-000049121, Exp Date: 19-Apr-26; Lot # C274-000049127, Exp Date: 21-Apr-26; Lot # C274-000049252, Exp Date: 26-Apr-26; Lot # C274-000049260, Exp Date: 28-Apr-26; Lot # C274-000049401, Exp Date: 3-May-26; Lot # C274-000049413, Exp Date: 5-May-26; Lot # C274-000049571, Exp Date: 10-May-26; Lot # C274-000049581, Exp Date: 12-May-26; Lot # C274-000049584, Exp Date: 13-May-26; Lot # C274-000049717, Exp Date: 17-May-26; Lot # C274-000049727, Exp Date: 18-May-26. — Status: Ongoing (voluntary: firm initiated)
D-0335-2026 · 10,548 bags
Lack of Assurance of Sterility
vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59 — Distribution: US Nationwide. — Lots/codes: Lot # C274-000049628, Exp Date: 3-May-26. — Status: Ongoing (voluntary: firm initiated)
D-0336-2026 · 1578 bags
Lack of Assurance of Sterility
vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59. — Distribution: US Nationwide. — Lots/codes: Lot # C274-000047611, Exp Date: 10-Feb-26; Lot # C274-000049633, Exp Date: 12-May-26. — Status: Ongoing (voluntary: firm initiated)
D-0337-2026 · N/A
Potential contamination with patulin.
tippy toes apple pear banana 6 months & up baby food 2-4OZ (113g) PACKS NET WT 8 OZ (226g) DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 1-888-423-0139 PRODUCT OF USA UPC: 036800265783 — Distribution: U.S. Consignees: IL — Lots/codes: Lot: 07174 BB: 07/17/2026 — Status: Ongoing (voluntary: firm initiated)
H-0544-2026 · 1375 cases
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01 — Distribution: Nationwide in the USA — Lots/codes: Lot #: A240421, Exp 07/31/2026 — Status: Ongoing (voluntary: firm initiated)
D-0398-2026 · 62190 vials
Label declares bovine colostrum but does not declare milk allergen.
Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, Net Wt., 1 fl oz (30 ml) liquid dietary supplement, Glass bottle with dropper cap. (Individual 1 fl oz bottles (not sold in case lots) — Distribution: Product was distributed to: AR, FL, CO, CA, CT, HI, IN, IL, ID, IA, KS, KY, LA, OH, OK, OR, MA, MI, MN, MO, GA, NC, NE, ND, NY, PA, SC, TN, NJ, UT, TX, VA , WA, WV, WI, WY — Lots/codes: LOT: 0528D911 Expiration Date: May 2028 — Status: Ongoing (voluntary: firm initiated)
H-0537-2026 · 442 units (bottles)
Label lists semolina and durum flour as sub-ingredients of the pasta, but does not declare wheat
Coco's Italian Market Heat-n-Eat Fettuccini Alfredo in homemade Alfredo Sauce, Net Wt. 19 oz. (510g), Keep Frozen, packaged in a microwaveable plastic container, UPC 0680334993607 — Distribution: TN — Lots/codes: Product Number: 993607; all lot codes within shelf life — Status: Completed (voluntary: firm initiated)
H-0553-2026 · 31 retail units
Label lists flour as a sub-ingredient of the shells, and ricotta cheese as a sub-ingredient of the cream but does not declare wheat or milk.
Coco's Italian Market Cannoli Making Kit with 6 Cannoli Shells & Cream, Net Wt. 8 oz. (227g), Keep Frozen, packaged in a plastic container, UPC 0680334992716 — Distribution: TN — Lots/codes: Product Number: 9927816; all lot codes within shelf life — Status: Completed (voluntary: firm initiated)
H-0554-2026 · 11 retail units
cGMP deviations
Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11 — Distribution: Nationwide in the USA — Lots/codes: Lot Numbers J01 through J14, J55 through J69 — Status: Ongoing (voluntary: firm initiated)
D-0302-2026 · N/A
cGMP deviations
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-112-11 — Distribution: Nationwide in the USA — Lots/codes: Lot Number J15 — Status: Ongoing (voluntary: firm initiated)
D-0303-2026 · N/A
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