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.
12 recalls
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Class II Ongoing
L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- All lots within expiry.
- Distribution
- US Nationwide.
- Quantity
- 83
- Recall started
- July 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0056-2026
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Class II Ongoing
L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- All lots within expiry.
- Distribution
- US Nationwide.
- Quantity
- 53
- Recall started
- July 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0055-2026
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Class II Ongoing
LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, and Lidocaine 1 mg in…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, and Lidocaine 1 mg in SWFI), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
- Lots / codes
- Lot #: H227226, Exp 12/24/2025; H360175, Exp 6/2/2025; H368308, Exp 6/2/2025; Lot S360175, Exp 6/2/2025
- Distribution
- USA Nationwide
- Quantity
- 102 syringes
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0477-2025
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Class II Ongoing
GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-vial, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch #: 10122105A2, Exp 3/20/2022; 01182216A1, Exp 5/31/2022; 02192207A1, Exp 7/31/2022; 03072206A1, Exp 9/3/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 60 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-1204-2022
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Class II Ongoing
GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch #: 10122110A2, Exp 3/20/2022; 12062110A2, Exp 4/30/2022; 02012202A2, 02192207A1, Exp 7/31/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 90 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-1203-2022
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Class II Ongoing
Ultra Amino Energy Cocktail (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 125mg/Thiamine HCL 50mg/Riboflavin-5-Phosphate Sod 5mg/Miacinamide 20mg/Pyridoxine HCL 2mg/Foli…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Ultra Amino Energy Cocktail (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 125mg/Thiamine HCL 50mg/Riboflavin-5-Phosphate Sod 5mg/Miacinamide 20mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 50mg/Chromium Picolinate 200mcg/Glutamine (L) 30mg/Arginine HCL 200mg/Lidocaine HCL 10mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy
- Lots / codes
- Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05232016B (11/19/2016), 07272016C (11/30/2016), 07152016H (11/30/2016), 09152016B (12/31/2016), 11022016B (05/01/2017), 06082016B (11/30/2016), 08172016C (12/31/2016), 10202016C (02/28/2017).
- Distribution
- Nationwide
- Quantity
- 870 vials
- Recall started
- November 17, 2016 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0322-2017
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Class II Ongoing
Ultra Amino Blend (Arginine HCL 105 mg + Lysine (L) HCL 150 mg + Ornithine (L) HCL 75 mg + Glutamine (L) 75 mg/ml + Lidocaine HCL 10 mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Ultra Amino Blend (Arginine HCL 105 mg + Lysine (L) HCL 150 mg + Ornithine (L) HCL 75 mg + Glutamine (L) 75 mg/ml + Lidocaine HCL 10 mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy
- Lots / codes
- Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06302016A (12/27/2016), 06152016F (12/12/2016), 08152016D (02/11/2017).
- Distribution
- Nationwide
- Quantity
- 79 vials
- Recall started
- November 17, 2016 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0321-2017
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Class II Ongoing
Tri-Amino (Ornithine (L) HCL 100 mg/Arginine HCL 100 mg/Citrulline (L) 100 mg/Lidocaine HCL 10 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Tri-Amino (Ornithine (L) HCL 100 mg/Arginine HCL 100 mg/Citrulline (L) 100 mg/Lidocaine HCL 10 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
- Lots / codes
- Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07262016F (01/22/2017), 08092016A (02/05/2017), 09152016E (02/28/2017).
- Distribution
- Nationwide
- Quantity
- 78 vials
- Recall started
- November 17, 2016 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0308-2017
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Class II Ongoing
L-Arginine HCL 100 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- L-Arginine HCL 100 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
- Lots / codes
- Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07282016H (01/24/2017), 09282016E (03/27/2017)
- Distribution
- Nationwide
- Quantity
- 41 vials
- Recall started
- November 17, 2016 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0266-2017
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Class II Ongoing
GAC, L-Glutamine/L-Arginine/L-Carnitine 25 mg/100 mg/200 mg/mL (30 mL). Tri-Coast Pharmacy.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- GAC, L-Glutamine/L-Arginine/L-Carnitine 25 mg/100 mg/200 mg/mL (30 mL). Tri-Coast Pharmacy.
- Lots / codes
- Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06172016A (12/14/2016), 08092016B (02/05/2014), 09262016A (03/25/2017), 10132016E (02/28/2017).
- Distribution
- Nationwide
- Quantity
- 114 vials
- Recall started
- November 17, 2016 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0257-2017
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Class II Ongoing
Methylcobalamin P 10/ml Creatine 40 mg/ml / Arginine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lots, distribution and details
- Lots / codes
- B0001 Exp 8/1/13
- Distribution
- Nationwide and PR
- Quantity
- 1
- Recall started
- May 29, 2013 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-755-2013
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Class II Ongoing
L-ArGiNINE 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lots, distribution and details
- Lots / codes
- B0005 Exp 8/5/13
- Distribution
- Nationwide and PR
- Quantity
- 1
- Recall started
- May 29, 2013 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-747-2013
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.