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.
3,222 recalls
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Class III Ongoing
Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91
Reason: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Lots, distribution and details
- Lots / codes
- Lot #: 550172201, Exp. Date JAN-26; 550184801, Exp. Date MAR-26; 550204001, Exp. Date JUL-26
- Distribution
- Nationwide within the United States
- Quantity
- 2,035 cartons
- Recall started
- October 10, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0142-2026
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Class III Ongoing
Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91
Reason: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Lots, distribution and details
- Lots / codes
- Lot #: 550162801, Exp. Date NOV-25; 550169801, Exp. Date JAN-26
- Distribution
- Nationwide within the United States
- Quantity
- 935 cartons
- Recall started
- October 10, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0141-2026
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Class III Ongoing
Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91
Reason: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Lots, distribution and details
- Lots / codes
- Lot #: 550167301, 550167401, Exp. Date NOV-25; 550185101, Exp. Date MAR-26; 550205701, Exp. Date JUL-26
- Distribution
- Nationwide within the United States
- Quantity
- 1,866 cartons
- Recall started
- October 10, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0140-2026
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Class III Ongoing
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91
Reason: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Lots, distribution and details
- Lots / codes
- Lot #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26
- Distribution
- Nationwide within the United States
- Quantity
- 6,655 cartons
- Recall started
- October 10, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0139-2026
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Class III Ongoing
Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604
Reason: Labeling: Not Elsewhere Classified
Lots, distribution and details
- Lots / codes
- Batch # 24G15-T02-115604, exp. 11/30/2026
- Distribution
- Product was distributed to: Letco Medical, LLC 1316 Commerce Drive Decatur, AL 35601 Product was further distributed to 44 compounding pharmacies and 2 distributors.
- Quantity
- 173 500 ml bottles
- Recall started
- September 12, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0138-2026
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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
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
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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
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
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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
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
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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
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
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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
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
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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
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
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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
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
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Class II Ongoing
Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01
Reason: CGMP Deviations: Potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot# 3171, 3172, Exp 2/11/2026
- Distribution
- Nationwide in the USA and Antigua
- Quantity
- 18,124 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-0130-2026
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Class II Ongoing
Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01
Reason: CGMP Deviations: Potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot, expiry: 3201, Exp 2/7/2026; 3202, Exp 2/21/2026; 3280, Exp 4/8/2026; 3283, Exp /9/2026.
- Distribution
- Nationwide in the USA and Antigua
- Quantity
- 14,329 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-0129-2026
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Class II Ongoing
Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0401-01
Reason: CGMP Deviations: Potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot: 3178, Exp 02/7/2026
- Distribution
- Nationwide in the USA and Antigua
- Quantity
- 4,829 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-0128-2026
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Class II Ongoing
Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0381-01
Reason: CGMP Deviations: Potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot, expiry: Lot 3203, exp 2/17/2026; Lot 3284, exp 4/8/2026
- Distribution
- Nationwide in the USA and Antigua
- Quantity
- 4,929 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-0127-2026
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Class II Ongoing
Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0386-01
Reason: CGMP Deviations: Potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot 3193, Exp 2/17/2026
- Distribution
- Nationwide in the USA and Antigua
- Quantity
- 529 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-0126-2026
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Class II Ongoing
Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01
Reason: CGMP Deviations: Potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot 3180, EXP 2/17/2026
- Distribution
- Nationwide in the USA and Antigua
- Quantity
- 829 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-0125-2026
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Class II Ongoing
Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01
Reason: CGMP Deviations: Potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot 3179, EXP 02/17/2026
- Distribution
- Nationwide in the USA and Antigua
- Quantity
- 829 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-0124-2026
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Class II Ongoing
Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0389-01
Reason: CGMP Deviations: Potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot 3294, EXP 4/8/2026
- Distribution
- Nationwide in the USA and Antigua
- Quantity
- 1,329pellets
- 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-0123-2026
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Class II Ongoing
Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1 Waterview Dr. Shelton, CT, Made in the USA UPC 738743190015
Reason: Product Mix-up
Lots, distribution and details
- Lots / codes
- Lot #: 2251994, Exp 9/30/2029
- Distribution
- USA Nationwide
- Quantity
- 2338 boxes
- Recall started
- September 23, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0122-2026
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Class II Ongoing
TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04.
Reason: Defective Container
Lots, distribution and details
- Lots / codes
- Lot: EJA022, expiry: 04/30/2028
- Distribution
- U.S. Nationwide – CO, IL, OH and IN.
- Quantity
- 3,816 bottles
- Recall started
- October 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0121-2026
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Class II Ongoing
Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03
- Lots / codes
- Lot PRORX08062025-3
- Distribution
- TX and UT
- Quantity
- 2,761 vials
- Recall started
- October 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0120-2026
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Class II Ongoing
Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02
- Lots / codes
- Lot PRORX052125-4
- Distribution
- TX and UT
- Quantity
- 2,805 vials
- Recall started
- October 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0119-2026
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Class II Ongoing
Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06
- Lots / codes
- Lot Prorx051525-5
- Distribution
- TX and UT
- Quantity
- 2,649 vials
- Recall started
- October 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0118-2026
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 November 2, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.