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Drug Recalls

Last updated

Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.

0 Class I (most serious) drug recalls reported in the last 30 days.

71 recalls

  • Class II Ongoing

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

    Reason: Presence of Foreign substance – potential presence of metal particulate matter

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

    Lots, distribution and details
    Lots / codes
    Lot#: 254000105, Exp. 05/28/2026, 254000110, Exp. 08/07/2026; 254000112, 254000113, Exp. 09/26/2026.
    Distribution
    Nationwide in the USA
    Quantity
    1,464 pellets.
    Recall started
    January 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0331-2026
  • 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.

    Reason: Presence of Foreign substance – potential presence of metal particulate matter

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

    Lots, distribution and details
    Lots / codes
    Lot#: 256000103, Exp. 07/28/2026.
    Distribution
    Nationwide in the USA
    Quantity
    1,631 pellets
    Recall started
    January 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0330-2026
  • Class II Ongoing

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

    Reason: Presence of Foreign substance – potential presence of metal particulate matter

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

    Lots, distribution and details
    Lots / codes
    Lot#: 256000105, Exp. 09/19/2026.
    Distribution
    Nationwide in the USA
    Quantity
    7,840 pellets
    Recall started
    January 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0329-2026
  • Class II Ongoing

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

    Reason: Presence of Foreign substance – potential presence of metal particulate matter

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

    Lots, distribution and details
    Lots / codes
    Lot#: 256000104, Exp. 07/30/2026. .
    Distribution
    Nationwide in the USA
    Quantity
    4,599 pellets
    Recall started
    January 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0328-2026
  • Class II Ongoing

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

    Reason: Presence of Foreign substance – potential presence of metal particulate matter

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

    Lots, distribution and details
    Lots / codes
    Lot#: 254000107, Exp. 06/30/2026; 254000111, Exp. 08/07/2026. .
    Distribution
    Nationwide in the USA
    Quantity
    670 pellets
    Recall started
    January 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0327-2026
  • Class II Ongoing

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

    Reason: Presence of Foreign substance – potential presence of metal particulate matter

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

    Lots, distribution and details
    Lots / codes
    Lot#: 254000104, Exp. 05/27/2026
    Distribution
    Nationwide in the USA
    Quantity
    100 pellets
    Recall started
    January 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0326-2026
  • Class II Ongoing

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

    Reason: Presence of Foreign substance – potential presence of metal particulate matter

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

    Lots, distribution and details
    Lots / codes
    Lot#: 251000124, Exp. 06/02/2026.
    Distribution
    Nationwide in the USA
    Quantity
    1,015 pellets
    Recall started
    January 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0325-2026
  • Class II Ongoing

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

    Reason: Presence of Foreign substance – potential presence of metal particulate matter

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

    Lots, distribution and details
    Lots / codes
    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.
    Distribution
    Nationwide in the USA
    Quantity
    194,336 pellets
    Recall started
    January 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0324-2026
  • Class II Ongoing

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

    Reason: Presence of Foreign substance – potential presence of metal particulate matter

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

    Lots, distribution and details
    Lots / codes
    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.
    Distribution
    Nationwide in the USA
    Quantity
    153,498 pellets
    Recall started
    January 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0323-2026
  • Class II Ongoing

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

    Reason: Presence of Foreign substance – potential presence of metal particulate matter

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

    Lots, distribution and details
    Lots / codes
    Lot#: 251000145, Exp. 07/14/2026; 251000161, Exp. 08/16/2026; 251000175, Exp. 09/08/2026. .
    Distribution
    Nationwide in the USA
    Quantity
    62,581 pellets.
    Recall started
    January 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0322-2026
  • Class II Ongoing

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

    Reason: Presence of Foreign substance – potential presence of metal particulate matter

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

    Lots, distribution and details
    Lots / codes
    Lot#: 251000125, Exp. 06/02/2026.
    Distribution
    Nationwide in the USA
    Quantity
    1,758 pellets.
    Recall started
    January 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0321-2026
  • Class II Ongoing

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

    Reason: Presence of Foreign substance – potential presence of metal particulate matter

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

    Lots, distribution and details
    Lots / codes
    Lot#: 251000122, Exp. 04/01/2026; 251000151, Exp. 08/02/2026; 251000155, Exp. 08/08/2026; 251000173, Exp. 09/05/2026.
    Distribution
    Nationwide in the USA
    Quantity
    70,959 pellets.
    Recall started
    January 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0320-2026
  • Class II Ongoing

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

    Reason: Presence of Foreign substance – potential presence of metal particulate matter

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

    Lots, distribution and details
    Lots / codes
    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.
    Distribution
    Nationwide in the USA
    Quantity
    60,868 pellets.
    Recall started
    January 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0319-2026
  • Class II Ongoing

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

    Reason: Presence of Foreign substance – potential presence of metal particulate matter

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

    Lots, distribution and details
    Lots / codes
    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
    Distribution
    Nationwide in the USA
    Quantity
    89,074 pellets
    Recall started
    January 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0318-2026
  • Class II Ongoing

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

    Reason: Presence of Foreign substance – potential presence of metal particulate matter

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

    Lots, distribution and details
    Lots / codes
    Lot#: 251000126, Exp. 06/03/2026.
    Distribution
    Nationwide in the USA
    Quantity
    146 pellets
    Recall started
    January 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0317-2026
  • Class II Ongoing

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

    Reason: Presence of Foreign substance – potential presence of metal particulate matter

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

    Lots, distribution and details
    Lots / codes
    Lot#: 251000143, Exp. 07/07/2026; 251000160, Exp. 08/16/2026.
    Distribution
    Nationwide in the USA
    Quantity
    3,871 pellets
    Recall started
    January 26, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0316-2026
  • Class II Ongoing

    TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01

    Reason: Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.

    Advanced Pharmaceutical Technology, Inc.

    Lots, distribution and details
    Lots / codes
    Lot #: P-22-3, Exp 06-2027
    Distribution
    GA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece
    Quantity
    22,843 pellets
    Recall started
    October 3, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0258-2026
  • Class III Ongoing

    Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ…

    Reason: Defective Container – A defect in the side-seal which allows leakage of product.

    Teva Pharmaceuticals USA, Inc · Testosterone

    Lots, distribution and details
    Product
    Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.
    Lots / codes
    Lot #100068692, Exp.: 04/30/2027
    Distribution
    U.S. Nationwide
    Quantity
    15,944 cartons
    Recall started
    November 7, 2025 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0198-2026
  • Class II Ongoing

    Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0364-01

    Reason: CGMP Deviations: Potential presence of metal particulate matter

    FARMAKEIO OUTSOURCING LLC

    Lots, distribution and details
    Lots / codes
    Lot, expiry: 3075, Exp 1/2/2026; 3084, Exp 1/6/2026; 3110, Exp 1/15/2026; 3115, Exp 1/16/2026; 3116, Exp 1/20/2026; 3119, Exp 1/21/2026; 3121, Exp 1/22/2026; 3124, Exp 1/23/2026; 3125, Exp 1/28/2026; 3131, Exp 1/29/2026; 3134, Exp 2/3/2026; 3135, Exp 2/4/2026; 3139, Exp 2/6/2026; 3204, Exp 2/13/2026; 3205, Exp 2/18/2026; 3207, Exp 2/19/2026; 3208, Exp 2/24/2026; 3211, Exp 2/25/2026; 3213, Exp 2/26/2026; 3216, Exp 2/27/2026; 3223, Exp 3/4/2026; 3225, Exp 3/5/2026; 3228, Exp 3/6/2026; 3248, Exp 3/19/2026; 3254, Exp 3/25/2026; 3258, Exp 3/31/2026; 3269, Exp 4/1/2026; 3270, Exp 4/10/2026.
    Distribution
    Nationwide in the USA and Antigua
    Quantity
    264,664 pellets
    Recall started
    October 14, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0137-2026
  • Class II Ongoing

    Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01

    Reason: CGMP Deviations: Potential presence of metal particulate matter

    FARMAKEIO OUTSOURCING LLC

    Lots, distribution and details
    Lots / codes
    Lot, expiry: 3098, 3101, Exp 1/8/2026; 3107, Exp 1/13/2026; 3108, Exp 1/14/2026; 3109, Exp 1/15/2026; 3230, Exp 3/10/2026; 3231, Exp 3/11/2026; 3235, Exp 3/13/2026; 3236, Exp 3/17/2026; 3241, Exp 3/17/2026; 3242, Exp 3/18/2026.
    Distribution
    Nationwide in the USA and Antigua
    Quantity
    103,444 pellets
    Recall started
    October 14, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0136-2026
  • Class II Ongoing

    Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0382-01

    Reason: CGMP Deviations: Potential presence of metal particulate matter

    FARMAKEIO OUTSOURCING LLC

    Lots, distribution and details
    Lots / codes
    Lot, expiry: 3194, 3195, Exp 2/17/2026; 3196, 3197, Exp 2/18/2026.
    Distribution
    Nationwide in the USA and Antigua
    Quantity
    21,324 pellets
    Recall started
    October 14, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0135-2026
  • Class II Ongoing

    Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0366-01

    Reason: CGMP Deviations: Potential presence of metal particulate matter

    FARMAKEIO OUTSOURCING LLC

    Lots, distribution and details
    Lots / codes
    Lot: 3090, Exp 1/7/2026; 3181, Exp 2/11/2026; 3189, 3190, Exp 2/12/2026
    Distribution
    Nationwide in the USA and Antigua
    Quantity
    31,124 pellets
    Recall started
    October 14, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0134-2026
  • Class II Ongoing

    Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01

    Reason: CGMP Deviations: Potential presence of metal particulate matter

    FARMAKEIO OUTSOURCING LLC

    Lots, distribution and details
    Lots / codes
    Lot: 3091, 3096, Exp 1/7/2026; 3097, Exp 1/7/2026; 3182, 3186, 3187, 3188, Exp 2/10/2026
    Distribution
    Nationwide in the USA and Antigua
    Quantity
    64,924 pellets
    Recall started
    October 14, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0133-2026
  • Class II Ongoing

    Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0380-01

    Reason: CGMP Deviations: Potential presence of metal particulate matter

    FARMAKEIO OUTSOURCING LLC

    Lots, distribution and details
    Lots / codes
    Lot, expiry: 3143, Exp 2/5/2026; 3160, 3161, Exp 2/11/2026; 3165, 3166, Exp 2/12/2026.
    Distribution
    Nationwide in the USA and Antigua
    Quantity
    43,424 Pellets
    Recall started
    October 14, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0132-2026
  • Class II Ongoing

    Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01

    Reason: CGMP Deviations: Potential presence of metal particulate matter

    FARMAKEIO OUTSOURCING LLC

    Lots, distribution and details
    Lots / codes
    Lot: 3148, 3154, 3155, Exp 2/5/2026; 3162, Exp 2/11/2026; 3167, Exp 2/12/2026
    Distribution
    Nationwide in the USA and Antigua
    Quantity
    36,924 pellets
    Recall started
    October 14, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0131-2026

Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.

What the recall classes mean

  • Class I Most serious: use could cause serious health problems or death.
  • Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
  • Class III Not likely to cause health problems — for example a labelling or packaging fault.

Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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