Every food and medication enforcement action the FDA has published in the last six months. No account needed — this is public record, made readable.
326 ENFORCEMENT ACTIONS · CLASS I MEANS A REASONABLE PROBABILITY OF SERIOUS HARM
Lack of Assurance of Sterility
Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03. — Distribution: OH — Lots/codes: Lot 240709, exp 7/31/2026 — Status: Ongoing (voluntary: firm initiated)
D-0394-2026 · 23 vials
Lack of Assurance of Sterility
Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04. — Distribution: OH — Lots/codes: Lot 240709, exp 7/31/2026 — Status: Ongoing (voluntary: firm initiated)
D-0395-2026 · 45 vials
Subpotent Drug
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44 — Distribution: Nationwide — Lots/codes: Lot 16240062A, exp date 3/2026 — Status: Ongoing (voluntary: firm initiated)
D-0403-2026 · 1315 bottles
Failed Dissolution Specifications
Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93. — Distribution: Nationwide within the United States — Lots/codes: Lot #: 3116110, 3116130, Exp. Date 07/2026 — Status: Ongoing (voluntary: firm initiated)
D-0399-2026 · 34850 blister packs
Failed Tablet/Capsule Specifications
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35 — Distribution: Nationwide in the US, including Puerto Rico — Lots/codes: Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027 — Status: Ongoing (voluntary: firm initiated)
D-0401-2026 · 2,699 blister cartons
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17 — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027 — Status: Ongoing (voluntary: firm initiated)
D-0381-2026 · 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each), NDC 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17 — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 5GJ0223, Exp 04/30/2027 — Status: Ongoing (voluntary: firm initiated)
D-0382-2026 · 164 cartons
Stability Data Does Not Support Expiry Date.
FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016. — Distribution: Nationwide within the U.S — Lots/codes: Lot #: 839CP-0016, Exp. Date 03/31/2026; 839CP-0017, Exp. Date 06/30/2026; 839CP-0018, Exp. Date 08/31/2026; 839CP-0019, Exp. Date 10/31/2026; 839CP-0020, Exp. Date 03/31/2027; 839CP-0021, Exp. Date 07/31/2027; 839CP-0022, Exp.Date 11/30/2027; 839CP-0023, Exp. Date 02/29/2028; 839CP-0024, Exp. Date 07/31/2028. — Status: Ongoing (voluntary: firm initiated)
D-0385-2026 · 27,380 bottles.
Stability Data Does Not Support Expiry Date.
MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014. — Distribution: Nationwide within the U.S — Lots/codes: Lot #: 807CP-0003, Exp. Date 07/31/2026. — Status: Ongoing (voluntary: firm initiated)
D-0386-2026 · 178 bottles
Stability Data Does Not Support Expiry Date.
MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015. — Distribution: Nationwide within the U.S — Lots/codes: Lot #: 795CP-0005, Exp. Date 06/30/2026 — Status: Ongoing (voluntary: firm initiated)
D-0387-2026 · 243 bottles
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
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
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80 — Distribution: Nationwide within the USA. — Lots/codes: All lots within expiry — Status: Ongoing (voluntary: firm initiated)
D-0343-2026 · N/A
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
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
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
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
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
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
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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