Medicamentos y Fármacos Recalls

Pharmaceutical recall notices, chemical impurities, and biological contamination.

Showing 24 of 649 results
PharmaceuticalUSFDA Drugs

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

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

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

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalUSFDA Drugs

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

Fresenius Kabi Compounding, LLC
FDA DrugsClass II

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

Feb 18, 2026Fresenius Kabi Compounding, LLC
PharmaceuticalUSFDA Drugs

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

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

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

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalUSFDA Drugs

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

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

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

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalUSFDA Drugs

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

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

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

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalUSFDA Drugs

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

Fresenius Kabi Compounding, LLC
FDA DrugsClass II

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

Feb 18, 2026Fresenius Kabi Compounding, LLC
PharmaceuticalUSFDA Drugs

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

Fresenius Kabi Compounding, LLC
FDA DrugsClass II

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

Feb 18, 2026Fresenius Kabi Compounding, LLC
PharmaceuticalUSFDA Drugs

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

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

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

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalUSFDA Drugs

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

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

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

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalUSFDA Drugs

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

Pro Numb Tattoo Numbing Spray LLC
FDA DrugsClass II

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

Feb 18, 2026Pro Numb Tattoo Numbing Spray LLC
PharmaceuticalUSFDA Drugs

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 69448-025-63

McKesson
FDA DrugsClass I

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 69448-025-63

Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.

Feb 18, 2026McKesson
PharmaceuticalUSFDA Drugs

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

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

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

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalUSFDA Drugs

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

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

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

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalUSFDA Drugs

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

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

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

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalUSFDA Drugs

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

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

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

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalUSFDA Drugs

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

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

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

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalUSFDA Drugs

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

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

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

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalUSFDA Drugs

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.

Fresenius Kabi Compounding, LLC
FDA DrugsClass II

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

Feb 18, 2026Fresenius Kabi Compounding, LLC
PharmaceuticalUSFDA Drugs

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

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

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

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalUSFDA Drugs

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.

Fresenius Kabi Compounding, LLC
FDA DrugsClass II

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

Feb 18, 2026Fresenius Kabi Compounding, LLC
PharmaceuticalUSFDA Drugs

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

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

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

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalUSFDA Drugs

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 Unichem Laboratories Limited, Plot Number 15 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa (India) 403511, NDC 29300-353-10.

Unichem Pharmaceuticals USA Inc.
FDA DrugsClass III

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 Unichem Laboratories Limited, Plot Number 15 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa (India) 403511, NDC 29300-353-10.

Tablets/Capsules Imprinted with Wrong ID

Feb 18, 2026Unichem Pharmaceuticals USA Inc.
PharmaceuticalUSFDA Drugs

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

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

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

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)
PharmaceuticalUSFDA Drugs

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

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

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

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)

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