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
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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 III Ongoing
Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01
Reason: Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Lots, distribution and details
- Lots / codes
- Lot number: 1043, Exp. Date 2/10/2026
- Distribution
- Nationwide within the United States.
- Quantity
- 2,832 amber vials
- Recall started
- June 16, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0517-2025
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Class II Ongoing
TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsf…
Reason: Marketed Without an Approved NDA/ANDA
Lots, distribution and details
- Product
- TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01
- Lots / codes
- Lot P-24-1; Exp. 02/28/2027
- Distribution
- NY, NJ
- Quantity
- 26 vials
- Recall started
- May 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0531-2025
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Class II Ongoing
Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX, 77064, Phone: (877) 562-8577, Compounding Date…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX, 77064, Phone: (877) 562-8577, Compounding Date: 08/20/2024, Beyond Use by Date: 05/28/2025, Lot 202364.
- Lots / codes
- Lot #: 202364, Exp 5/28/2025
- Distribution
- USA Nationwide
- Quantity
- 8,230 vials
- Recall started
- May 2, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0420-2025
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Class II Ongoing
TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0121-…
Reason: Presence of Particulate Matter: Glass particles were found in pellet vials.
Lots, distribution and details
- Product
- TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0121-01
- Lots / codes
- Lot 20250129@1, exp 1/17/2026; Lot 20250218@4, exp 1/25/2026
- Distribution
- Nationwide in the USA
- Quantity
- 1,964 vials
- Recall started
- April 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0416-2025
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Class II Ongoing
TESTOSTERONE PELLET 200 mg (with Cholesterol
Reason: Presence of Particulate Matter: Glass particles were found in pellet vials.
Lots, distribution and details
- Product
- TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0122-01
- Lots / codes
- Lot 20250205@6, exp 1/30/2026
- Distribution
- Nationwide in the USA
- Quantity
- 1,447 vials
- Recall started
- April 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0415-2025
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Class II Ongoing
TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol
Reason: Presence of Particulate Matter: Glass particles were found in pellet vials.
Lots, distribution and details
- Product
- TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0124-01
- Lots / codes
- Lot 20250217@7, exp 1/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 355 vials
- Recall started
- April 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0414-2025
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Class II Ongoing
TESTOSTERONE PELLET 200 mg (with Cholesterol
Reason: Presence of Particulate Matter: Glass particles were found in pellet vials.
Lots, distribution and details
- Product
- TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0125-01
- Lots / codes
- Lot 20250207@1, exp 1/31/2026; Lot 20250228@1, exp 1/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 1,974 vials
- Recall started
- April 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0413-2025
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Class II Ongoing
TESTOSTERONE PELLET 100 mg (with Cholesterol
Reason: Presence of Particulate Matter: Glass particles were found in pellet vials.
Lots, distribution and details
- Product
- TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0101-01
- Lots / codes
- Lot 20250102@6, exp 12/11/2025; Lot 20250130@4, exp 1/22/2026
- Distribution
- Nationwide in the USA
- Quantity
- 2,762 vials
- Recall started
- April 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0412-2025
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Class II Ongoing
Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01
Reason: cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Lots, distribution and details
- Product
- Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01
- Lots / codes
- Lot #: 1TC24075A, Exp 11/30/2026.
- Distribution
- Nationwide USA
- Quantity
- 36,816 vials
- Recall started
- April 10, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0363-2025
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Class II Ongoing
Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02
Reason: Presence of foreign substance: Presence of Benzene.
Lots, distribution and details
- Lots / codes
- Lot #: 5501103A, Exp Mar-25; 5501237A, 5501238A, Exp Apr-25; 5501278A, Exp May-25; 5501280A, 5501342A, Exp Jun-25; 5501372A, Exp Jul-25; 5501496A, Exp Aug-25; 5501499A, Exp Sep-25; 5501580A, Exp Oct-25; 5501582A, Exp Dec-25; 5501653A, 5501656A, Exp Jan-26; 5501770A, Exp Feb-26; 5501842A, 5501868A, 5501882A, Exp Apr-26; 5501957A, Exp May-26; 5502001A, Exp Jul-26; 5502033A, Exp Aug-26; 5502112A, 5502115A, Exp Oct-26; 5502180A, 5502181A, Exp Nov-26.
- Distribution
- Nationwide in the U.S
- Quantity
- 244,412 Cartons; 30 sachets /Carton
- Recall started
- March 5, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0294-2025
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Class II Ongoing
Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02
Reason: Presence of foreign substance: Presence of Benzene.
Lots, distribution and details
- Product
- Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02
- Lots / codes
- Lot #: 5501127A, 5501236A, Exp Apr-25; 5501341A, Exp Jun-25; 5501406A, Exp Jul-25; 5501408A, Exp Aug-25; 5501516A, Exp Sep-25; 5501568A, Exp Oct-25; 5501829A, Exp Mar-26; 5502000A, Exp Jul-26; 5502004A, 5502005A, Exp Aug-26; 5502092A, Exp Oct-26; 5502217A, Exp Dec-26; 5502262A, Exp Jan-27
- Distribution
- Nationwide in the U.S
- Quantity
- 195,952 Cartons; 30 sachets/Carton.
- Recall started
- March 5, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0293-2025
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Class II Ongoing
Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30
Reason: Superpotent Drug
Lots, distribution and details
- Lots / codes
- Lot #: 100042386, Exp. Date 06/2025
- Distribution
- Product was distributed nationwide within the United States
- Quantity
- 7,080 unit dose packets
- Recall started
- August 8, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0637-2024
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Class I Ongoing
Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64
Reason: Labeling: Label Mix-up – product labeled as tirzepatide contains testosterone cypionate
Lots, distribution and details
- Lots / codes
- Lot #: 748127, Exp 9/24/2024
- Distribution
- USA Nationwide
- Quantity
- 751 vials
- Recall started
- April 20, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0511-2024
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Class III Terminated
Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30
Reason: OOS for viscosity
Lots, distribution and details
- Lots / codes
- Lot #: 100029472, Exp. 2/29/2024
- Distribution
- USA nationwide
- Quantity
- —
- Recall started
- November 10, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0127-2024
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Class II Ongoing
Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213
- Lots / codes
- Lot #: AL-05222023@901, BUD 7/22/23; AL-06122023@908CS, BUD 8/11/23
- Distribution
- Nationwide
- Quantity
- 102 vials
- Recall started
- July 13, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0944-2023
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Class II Ongoing
Testosterone Propionate 100mg/ml, 10mL-vial, Room temperature, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Testosterone Propionate 100mg/ml, 10mL-vial, Room temperature, Tailor Made Compounding
- Lots / codes
- Batch#: 12012123A2, Exp 5/30/2022; 01312212A1, Exp 7/30/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 64 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1239-2022
-
Class II Ongoing
Testosterone Enanthate (GSO) 200mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch#: a)10142117A2, Exp 4/12/2022; 10272108A1, Exp 4/25/2022; 11302113A2, Exp 5/29/2022; 02252220A1, Exp 8/24/2022; b)10142108A2, Exp 4/12/2022; 12072134A1, Exp 6/5/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 414 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1238-2022
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.