Drug Recalls

1,822 drug recalls from federal enforcement feeds.

Showing 251–300 of 1,822

• Drug Recall · February 18, 2026

  HTO Nevada Inc. dba Kirkman

  FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.

  Stability Data Does Not Support Expiry Date.

  Class II

• Drug Recall · February 18, 2026

  HTO Nevada Inc. dba Kirkman

  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.

  Stability Data Does Not Support Expiry Date.

  Class II

• Drug Recall · February 17, 2026

  The Harvard Drug Group LLC

  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.

  Defective container; inadequately sealed blister packaging.

  Class II

• Drug Recall · February 13, 2026

  Harbin Jixianglong Biotech Co., Ltd.

  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 8438

  CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

  Class II

• Drug Recall · February 13, 2026

  AvKARE

  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.

  Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.

  Class II

• Drug Recall · February 13, 2026

  Harbin Jixianglong Biotech Co., Ltd.

  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: Harbi

  CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

  Class II

• Drug Recall · February 12, 2026

  Slate Run Pharmaceuticals

  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 Econ

  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.

  Class III

• Drug Recall · February 10, 2026

  LEO PHARMA INC

  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, Manu

  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.

  Class II

• Drug Recall · February 9, 2026

  Meitheal Pharmaceuticals, Inc

  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.

  Defective Delivery System: Missing or duplicated needles within the injection kit

  Class II

• Drug Recall · February 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

  Class II

• Drug Recall · February 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

  Class II

• Drug Recall · February 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, Canton, MA 02021, NDC 71506-035-56

  Lack of Assurance of Sterility

  Class II

• Drug Recall · February 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

  Class II

• Drug Recall · February 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

  Class II

• Drug Recall · February 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 08873, NDC carton: 70069-02

  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.

  Class II

• Drug Recall · February 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., Sengareddy - 502313, Telengana, Indi

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

  Class III

• Drug Recall · February 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, NDC 83389-111-11

  cGMP deviations

  Class II

• Drug Recall · February 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, Melbourne, FL 32907, NDC 83389-112-11

  cGMP deviations

  Class II

• Drug Recall · January 29, 2026

  Teva Pharmaceuticals USA, Inc

  Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11

  Failed Dissolution Specifications

  Class II

• Drug Recall · January 29, 2026

  Teva Pharmaceuticals USA, Inc

  Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.

  Failed Dissolution Specifications

  Class II

• Drug Recall · January 29, 2026

  Teva Pharmaceuticals USA, Inc

  Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

  Failed Dissolution Specifications

  Class II

• Drug Recall · January 29, 2026

  Teva Pharmaceuticals USA, Inc

  Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

  Failed Dissolution Specifications

  Class II

• Drug Recall · January 27, 2026

  SUN PHARMACEUTICAL INDUSTRIES INC

  Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 516

  Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  Radnostix

  Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC

  Presence of Particulate Matter: Due to production issues

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  Granules Pharmaceuticals Inc.

  Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151

  Presence of Foreign Tablets/Capsules

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II

• Drug Recall · January 26, 2026

  F.H. INVESTMENTS, Inc. (dba Asteria Health)

  Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.

  Presence of Foreign substance - potential presence of metal particulate matter

  Class II