Drugs Recalls

FDA Drug Class II Ongoing

Cetrorelix Acetate for Injection, 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90. Vial: Cetrorelix Acetate for Injection, 0.25 mg per vi

February 9, 2026 Meitheal Pharmaceuticals Inc 16,477 kits units

FDA Drug Class II Ongoing

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

February 5, 2026 Fresenius Kabi Compounding, LLC 1057 bags units

FDA Drug Class II Ongoing

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

February 5, 2026 Fresenius Kabi Compounding, LLC 1578 bags units

FDA Drug Class II Ongoing

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

February 5, 2026 Fresenius Kabi Compounding, LLC 1410 bags units

FDA Drug Class II Ongoing

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.

February 5, 2026 Fresenius Kabi Compounding, LLC 10,548 bags units

FDA Drug Class II Ongoing

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.

February 5, 2026 Fresenius Kabi Compounding, LLC N/A units

FDA Drug Class II Ongoing

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

February 2, 2026 Pro Numb Tattoo Numbing Spray LLC N/A units

FDA Drug Class II Ongoing

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

February 2, 2026 Pro Numb Tattoo Numbing Spray LLC N/A units

FDA Drug Class II Ongoing

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

January 27, 2026 Sun Pharmaceutical Industries Inc. N/A units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 50,990 pellets units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 670 pellets units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 1,464 pellets. units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 1,631 pellets units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 1,699 pellets units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 60,868 pellets. units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 70,959 pellets. units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 133 pellets units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 14,848 pellets units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 146 pellets units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 22,478 pellets. units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 715 pellets units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 4,599 pellets units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 1,015 pellets units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 100 pellets units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 3,871 pellets units

FDA Drug Class II Ongoing

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

January 26, 2026 Granules Pharmaceuticals Inc 71424 bottles. units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 7,840 pellets units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 62,581 pellets. units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 2,442 pellets. units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 89,074 pellets units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 194,336 pellets units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 153,498 pellets units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 24,099 pellets units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 1,758 pellets. units

FDA Drug Class II Ongoing

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

January 26, 2026 F.H. INVESTMENTS, Inc. (dba Asteria Health) 1,475 pellets units

FDA Drug Class III Ongoing

Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by

January 21, 2026 Unichem Pharmaceuticals Usa Inc 60,000 tablets units

FDA Drug Class II Ongoing

Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India

January 21, 2026 Unichem Pharmaceuticals Usa Inc N/A units

FDA Drug Class II Ongoing

Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02

January 16, 2026 Specialty Process Labs LLC 58 gms units

FDA Drug Class I Ongoing

UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-02

January 16, 2026 Mckesson 116 cartons units

FDA Drug Class II Ongoing

methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2

January 15, 2026 Greenstone Llc 3456 cartons units

FDA Drug Class II Ongoing

Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distribute

January 14, 2026 Amerisource Health Services LLC 31,676 packages units

FDA Drug Class II Ongoing

Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, I

January 10, 2026 Graviti Pharmaceuticals Private Limited 4212 bottles units

FDA Drug Class II Ongoing

AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each

January 6, 2026 Encon Safety Products Co 7677 bags units

FDA Drug Class II Ongoing

Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.

January 2, 2026 Cipla USA, Inc. 15,221 syringes units

FDA Drug Class II Ongoing

Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 477

December 31, 2025 Alvogen, Inc

FDA Drug Class II Ongoing

Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15

December 31, 2025 AvKARE 7,991 5x10 cartons units

FDA Drug Class II Ongoing

Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of

December 30, 2025 Glenmark Pharmaceuticals Inc., USA 96,948 packs units

FDA Drug Class III Ongoing

Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4

December 30, 2025 Sun Pharmaceutical Industries Inc. 24,624 bottles units

FDA Drug Class II Ongoing

Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-15

December 30, 2025 Zydus Pharmaceuticals USA Inc 22,896 bottles units

FDA Drug Class II Ongoing

TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT

December 26, 2025 GOLD STAR DISTRIBUTION INC