Class II · Posted February 18, 2026 · Started February 9, 2026 · Ongoing
Cetrorelix Acetate for Injection (Kit)
- Product
- 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.
- Firm
- Meitheal Pharmaceuticals, Inc, Chicago, IL
- Reason
- Defective Delivery System: Missing or duplicated needles within the injection kit
- Lots
- Lot Q4E0112A, Exp.: 30 Apr 2027
- Quantity
- 16,477 kits
- Distribution
- U.S. Nationwide
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0340-2026
Class II · Posted February 18, 2026 · Started February 5, 2026 · Ongoing
vancomycin HCl
- Product
- 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.
- Firm
- Fresenius Kabi Compounding, LLC, Canton, MA
- Reason
- Lack of Assurance of Sterility
- Lots
- Lot # C274-000047611, Exp Date: 10-Feb-26; Lot # C274-000049633, Exp Date: 12-May-26.
- Distribution
- US Nationwide.
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0337-2026
Class II · Posted February 18, 2026 · Started February 5, 2026 · Ongoing
vancomycin HCl
- Product
- 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
- Firm
- Fresenius Kabi Compounding, LLC, Canton, MA
- Reason
- Lack of Assurance of Sterility
- Lots
- Lot # C274-000049628, Exp Date: 3-May-26.
- Quantity
- 1578 bags
- Distribution
- US Nationwide.
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0336-2026
Class II · Posted February 18, 2026 · Started February 5, 2026 · Ongoing
thiamine HCl
- Product
- 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.
- Firm
- Fresenius Kabi Compounding, LLC, Canton, MA
- Reason
- Lack of Assurance of Sterility
- Lots
- 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.
- Quantity
- 10,548 bags
- Distribution
- US Nationwide.
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0335-2026
Class II · Posted February 18, 2026 · Started February 5, 2026 · Ongoing
ketamine HCl
- Product
- 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
- Firm
- Fresenius Kabi Compounding, LLC, Canton, MA
- Reason
- Lack of Assurance of Sterility
- Lots
- 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
- Quantity
- 1410 bags
- Distribution
- US Nationwide.
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0334-2026
Class II · Posted February 18, 2026 · Started February 5, 2026 · Ongoing
acyclovir sodium
- Product
- 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
- Firm
- Fresenius Kabi Compounding, LLC, Canton, MA
- Reason
- Lack of Assurance of Sterility
- Lots
- Lot # C274-000049124, Exp Date: 28-Feb-26.
- Quantity
- 1057 bags
- Distribution
- US Nationwide.
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0333-2026
Class II · Posted February 18, 2026 · Started February 2, 2026 · Ongoing
numbing spray
- Product
- 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
- Firm
- Pro Numb Tattoo Numbing Spray LLC, Palm Bay, FL
- Reason
- cGMP deviations
- Lots
- Lot Number J15
- Distribution
- Nationwide in the USA
- RxNorm
- numbing spray
- Recall number
- D-0303-2026
Class II · Posted February 18, 2026 · Started February 2, 2026 · Ongoing
tattoo numbing spray
- Product
- 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
- Firm
- Pro Numb Tattoo Numbing Spray LLC, Palm Bay, FL
- Reason
- cGMP deviations
- Lots
- Lot Numbers J01 through J14, J55 through J69
- Distribution
- Nationwide in the USA
- RxNorm
- tattoo numbing spray
- Recall number
- D-0302-2026
Class II · Posted February 18, 2026 · Started January 26, 2026 · Ongoing
Testosterone 100mg Anastrozole 4mg
- Product
- Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32
- Firm
- F.H. INVESTMENTS, Inc. (dba Asteria Health), Birmingham, AL
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Lots
- Lot#: 254000105, Exp. 05/28/2026, 254000110, Exp. 08/07/2026; 254000112, 254000113, Exp. 09/26/2026.
- Quantity
- 1,464 pellets.
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0331-2026
Class II · Posted February 18, 2026 · Started January 26, 2026 · Ongoing
Testosterone 87.5mg
- Product
- Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32.
- Firm
- F.H. INVESTMENTS, Inc. (dba Asteria Health), Birmingham, AL
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Lots
- Lot#: 256000103, Exp. 07/28/2026.
- Quantity
- 1,631 pellets
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0330-2026
Class II · Posted February 18, 2026 · Started January 26, 2026 · Ongoing
Testosterone 200mg
- Product
- Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.
- Firm
- F.H. INVESTMENTS, Inc. (dba Asteria Health), Birmingham, AL
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Lots
- Lot#: 256000105, Exp. 09/19/2026.
- Quantity
- 7,840 pellets
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0329-2026
Class II · Posted February 18, 2026 · Started January 26, 2026 · Ongoing
Testosterone 100mg
- Product
- Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32.
- Firm
- F.H. INVESTMENTS, Inc. (dba Asteria Health), Birmingham, AL
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Lots
- Lot#: 256000104, Exp. 07/30/2026. .
- Quantity
- 4,599 pellets
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0328-2026
Class II · Posted February 18, 2026 · Started January 26, 2026 · Ongoing
Testosterone 75mg
- Product
- Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.
- Firm
- F.H. INVESTMENTS, Inc. (dba Asteria Health), Birmingham, AL
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Lots
- Lot#: 254000107, Exp. 06/30/2026; 254000111, Exp. 08/07/2026. .
- Quantity
- 670 pellets
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0327-2026
Class II · Posted February 18, 2026 · Started January 26, 2026 · Ongoing
Testosterone 100mg
- Product
- Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01.
- Firm
- F.H. INVESTMENTS, Inc. (dba Asteria Health), Birmingham, AL
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Lots
- Lot#: 254000104, Exp. 05/27/2026
- Quantity
- 100 pellets
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0326-2026
Class II · Posted February 18, 2026 · Started January 26, 2026 · Ongoing
Testosterone
- Product
- Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01.
- Firm
- F.H. INVESTMENTS, Inc. (dba Asteria Health), Birmingham, AL
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Lots
- Lot#: 251000124, Exp. 06/02/2026.
- Quantity
- 1,015 pellets
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0325-2026
Class II · Posted February 18, 2026 · Started January 26, 2026 · Ongoing
Testosterone
- Product
- Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.
- Firm
- F.H. INVESTMENTS, Inc. (dba Asteria Health), Birmingham, AL
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Lots
- Lot#: 251000127, Exp. 06/03/2026; 251000128, Exp. 06/05/2026; 251000133, 251000134, 251000135, Exp. 06/16/2026; 251000138, 251000139, 251000140, 251000141, Exp. 06/25/2026; 251000147, 251000148, 251000149, Exp. 07/28/2026; 251000156, 251000157, Exp. 08/08/2026; 251000164, 251000165, 251000166, Exp. 08/22/2026; 251000169, Exp. 08/29/2026; 251000171, 251000172, Exp. 09/03/2026; 251000180, Exp. 09/19/2026.
- Quantity
- 194,336 pellets
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0324-2026
Class II · Posted February 18, 2026 · Started January 26, 2026 · Ongoing
Testosterone
- Product
- Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.
- Firm
- F.H. INVESTMENTS, Inc. (dba Asteria Health), Birmingham, AL
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Lots
- Lot#: 251000132, Exp. 06/16/2026; 251000142, Exp. 06/30/2026; 251000144, Exp. 07/14/2026; 251000146, Exp. 07/21/2026; 251000162, 251000163, Exp. 08/16/2026; 251000167, Exp. 08/22/2026; 251000177, Exp. 09/12/2026.
- Quantity
- 153,498 pellets
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0323-2026
Class II · Posted February 18, 2026 · Started January 26, 2026 · Ongoing
Testosterone
- Product
- Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.
- Firm
- F.H. INVESTMENTS, Inc. (dba Asteria Health), Birmingham, AL
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Lots
- Lot#: 251000145, Exp. 07/14/2026; 251000161, Exp. 08/16/2026; 251000175, Exp. 09/08/2026. .
- Quantity
- 62,581 pellets.
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0322-2026
Class II · Posted February 18, 2026 · Started January 26, 2026 · Ongoing
Testosterone
- Product
- Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32.
- Firm
- F.H. INVESTMENTS, Inc. (dba Asteria Health), Birmingham, AL
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Lots
- Lot#: 251000125, Exp. 06/02/2026.
- Quantity
- 1,758 pellets.
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0321-2026
Class II · Posted February 18, 2026 · Started January 26, 2026 · Ongoing
Testosterone
- Product
- Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.
- Firm
- F.H. INVESTMENTS, Inc. (dba Asteria Health), Birmingham, AL
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Lots
- Lot#: 251000122, Exp. 04/01/2026; 251000151, Exp. 08/02/2026; 251000155, Exp. 08/08/2026; 251000173, Exp. 09/05/2026.
- Quantity
- 70,959 pellets.
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0320-2026
Class II · Posted February 18, 2026 · Started January 26, 2026 · Ongoing
Testosterone
- Product
- Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.
- Firm
- F.H. INVESTMENTS, Inc. (dba Asteria Health), Birmingham, AL
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Lots
- Lot#: 251000131, Exp. 06/16/2026; 251000136, Exp. 08/02/2026; 251000150, Exp. 08/12/2026; 251000158, Exp. 08/14/2026; 251000159, Exp. 06/16/2026.
- Quantity
- 60,868 pellets.
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0319-2026
Class II · Posted February 18, 2026 · Started January 26, 2026 · Ongoing
Testosterone
- Product
- Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.
- Firm
- F.H. INVESTMENTS, Inc. (dba Asteria Health), Birmingham, AL
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Lots
- Lot#: 251000130, Exp. 06/02/2026; 251000137, 06/19/2026; 251000152, Exp. 08/02/2026; 251000168, Exp. 08/29/2026; 251000170, Exp. 09/03/2026
- Quantity
- 89,074 pellets
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0318-2026
Class II · Posted February 18, 2026 · Started January 26, 2026 · Ongoing
Testosterone
- Product
- Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32.
- Firm
- F.H. INVESTMENTS, Inc. (dba Asteria Health), Birmingham, AL
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Lots
- Lot#: 251000126, Exp. 06/03/2026.
- Quantity
- 146 pellets
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0317-2026
Class II · Posted February 18, 2026 · Started January 26, 2026 · Ongoing
Testosterone
- Product
- Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32.
- Firm
- F.H. INVESTMENTS, Inc. (dba Asteria Health), Birmingham, AL
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Lots
- Lot#: 251000143, Exp. 07/07/2026; 251000160, Exp. 08/16/2026.
- Quantity
- 3,871 pellets
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0316-2026
Class II · Posted February 18, 2026 · Started January 26, 2026 · Ongoing
ESTRADIOL
- Product
- ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32.
- Firm
- F.H. INVESTMENTS, Inc. (dba Asteria Health), Birmingham, AL
- Reason
- Presence of Foreign substance - potential presence of metal particulate matter
- Lots
- Lot#: 253000125, Exp. 06/09/2026.
- Quantity
- 715 pellets
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0315-2026