FDA · food & medication · last 6 months

The recall log.

Every food and medication enforcement action the FDA has published in the last six months. No account needed — this is public record, made readable.

914 ENFORCEMENT ACTIONS · CLASS I MEANS A REASONABLE PROBABILITY OF SERIOUS HARM

Class IIMedicationFeb 5, 2026

Fresenius Kabi Compounding, LLC: 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, Canto…

Lack of Assurance of Sterility

Product, lots & distribution

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

Class IIMedicationFeb 5, 2026

Fresenius Kabi Compounding, LLC: 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

Lack of Assurance of Sterility

Product, lots & distribution

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

Class IIMedicationFeb 5, 2026

Fresenius Kabi Compounding, LLC: 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.

Lack of Assurance of Sterility

Product, lots & distribution

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

Class IIMedicationFeb 5, 2026

Fresenius Kabi Compounding, LLC: 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

Lack of Assurance of Sterility

Product, lots & distribution

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

Class IIMedicationFeb 5, 2026

Fresenius Kabi Compounding, LLC: 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.

Lack of Assurance of Sterility

Product, lots & distribution

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

Class IIFoodFeb 5, 2026

IF Holding II, LLC: 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 O…

Potential contamination with patulin.

Product, lots & distribution

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

Class IIMedicationFeb 4, 2026

SOMERSET THERAPEUTICS LLC: 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…

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.

Product, lots & distribution

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

Class IIIMedicationFeb 3, 2026

Annora Pharma Private Limited: Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Seng…

Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg

Product, lots & distribution

Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01. — Distribution: TN — Lots/codes: Lot #: A252487, Exp 05/31/2027 — Status: Ongoing (voluntary: firm initiated)

D-0391-2026 · 770 bottles

Class IFoodFeb 3, 2026

Prime Food Processing LLC.: Prime Food Processing Dried Croaker Fish; NET WT: 8oz (227g); Ingredients: Croaker Fish, Salt; CONTAINS: FISH (CROAKER FISH); DISTRIBUTED BY: PFP LLC, Brooklyn, NY, 11211,…

Uneviscerated Fish

Product, lots & distribution

Prime Food Processing Dried Croaker Fish; NET WT: 8oz (227g); Ingredients: Croaker Fish, Salt; CONTAINS: FISH (CROAKER FISH); DISTRIBUTED BY: PFP LLC, Brooklyn, NY, 11211, USA; Product must be thoroughly cleaned and cooked before consumption.; PRODUCT OF VIETNAM; UPC: 6 946976 818000 — Distribution: AZ, CA, FL, GA, HI, ID, MA, MD, MO, NJ, NV, NY, OH, OK, PA, VA, WA, WI — Lots/codes: Item #AF1410 Expiration: 12-28-27 UPC Codes: #946976818000 — Status: Ongoing (voluntary: firm initiated)

H-0519-2026 · 79 cases

Class IIFoodFeb 3, 2026

Pure Solutions, Inc.: 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…

Label declares bovine colostrum but does not declare milk allergen.

Product, lots & distribution

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)

Class IIFoodFeb 3, 2026

Cocos Wholesale and Imports, LLC: 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…

Label lists semolina and durum flour as sub-ingredients of the pasta, but does not declare wheat

Product, lots & distribution

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

Class IIFoodFeb 3, 2026

Cocos Wholesale and Imports, LLC: 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

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.

Product, lots & distribution

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

Class IIMedicationFeb 2, 2026

Pro Numb Tattoo Numbing Spray LLC: 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, ND…

cGMP deviations

Product, lots & distribution

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

Class IIMedicationFeb 2, 2026

Pro Numb Tattoo Numbing Spray LLC: 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, Melb…

cGMP deviations

Product, lots & distribution

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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