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.
183 recalls
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Class II Ongoing
Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-620-01; NDC Unit Dose: 60687-620-11
Reason: Presence of Foreign Tablets/Capsules
Lots, distribution and details
- Product
- Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-620-01; NDC Unit Dose: 60687-620-11
- Lots / codes
- Lot 1028135, 1029555; Exp. Date 07/31/2027
- Distribution
- US Nationwide
- Quantity
- 5,363 cartons
- Recall started
- October 6, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0042-2027
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Class II Ongoing
Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.
Reason: Lack of process control
Lots, distribution and details
- Lots / codes
- Lot# SER-081726-1-10, Beyond Use Date: 10/01/2026.
- Distribution
- Nationwide in the USA.
- Quantity
- 7 vials
- Recall started
- September 25, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0041-2027
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Class II Ongoing
Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.
Reason: Lack of assurance of sterility.
Lots, distribution and details
- Lots / codes
- Lot# TZN-080326-20/2-2, Beyond Use Date: 12/01/2026.
- Distribution
- Nationwide in the USA.
- Quantity
- 64 vials
- Recall started
- September 25, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0040-2027
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Class II Ongoing
Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara – 391510 India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534,…
Reason: Failed Impurities/Degradation Specifications.
Lots, distribution and details
- Product
- Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara – 391510 India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1907-1.
- Lots / codes
- Lot #: LB00047A, LB00048A, Exp. Date 03/2028
- Distribution
- Nationwide within the United States
- Quantity
- 70776 vials
- Recall started
- October 1, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0039-2027
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Class II Ongoing
Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC 100 Tablets: 0093-2204-01; NDC 500 Tablets: 0093-2204-05
Reason: Presence of Foreign Tablets/Capsules
Lots, distribution and details
- Product
- Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC 100 Tablets: 0093-2204-01; NDC 500 Tablets: 0093-2204-05
- Lots / codes
- Lot, expiry: [100 Tablets] Lots 8634085, 8635085, 8636085, exp 07/2027; [500 Tablets] Lot 8633085, exp 07/2027
- Distribution
- US Nationwide.
- Quantity
- 240,448 cartons
- Recall started
- September 29, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0038-2027
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Not Yet Classified Ongoing
Tri-Immune Boost (Glutathione: 200 mg, Ascorbic Acid: 200 mg, Zinc: 2.5 mg), 30 mL vial, Rx only, Centric Compounding, 7447 Harwin Dr. Suite 111, Houston, TX 77036
Reason: Microbial Contamination of Sterile Products – out of specifications results were obtained for bacterial endotoxin.
Lots, distribution and details
- Lots / codes
- Lot #: 071626:B, Beyond Use Date: 8/30/26
- Distribution
- USA Nationwide.
- Quantity
- N/A
- Recall started
- July 27, 2026 (Voluntary: Firm initiated)
- Severity
- Not yet classified by the FDA.
- FDA recall number
- N/A
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Class II Ongoing
Apothecary NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vial, Rx Only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC, 27513, NDC 85091-011-06.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: AP-202647, BUD 13-Oct-2026
- Distribution
- Nationwide within the United States
- Quantity
- 1 vial
- Recall started
- September 24, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0037-2027
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Class II Ongoing
Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-001-18.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: AP-202622, BUD 07-Oct-2026; AP-202623, BUD 08-Oct-2026; AP-202624, BUD 19-Oct-2026; AP-202625, BUD 10/20/2026; AP-202627, BUD 10/26/2026; AP-202628, BUD 10/27/2026; AP-202629, BUD 10/28/2026; AP-202630, BUD 10/31/2026; AP-202631, BUD 11/01/2026; AP-202632, BUD 11/03/2026; AP-202633, BUD 11/07/2026; AP-202634, BUD 11/08/2026; AP-202635, BUD 11/16/2026; AP-202636, BUD 11/17/2026; AP-202637,BUD 11/18/2026; AP-202638, BUD 11/19/2026; AP-202639, BUD 11/20/2026; AP-202640, BUD 11/21/2026;AP-202641, BUD 11/22/2026; AP-202642, BUD 11/24/2026; AP-202643, BUD 11/25/2026; AP-202644, BUD 11/26/2026
- Distribution
- Nationwide within the United States
- Quantity
- 22 vials
- Recall started
- September 24, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0036-2027
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Class III Ongoing
Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-0.
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lot # AD96196, Exp Date: 12/31/2026.
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- September 25, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0035-2027
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Class III Ongoing
Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Product of Canada, NDC 16714-249-02.
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lot # AD96183, Exp Date: 12/31/2026.
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- September 25, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0034-2027
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Class III Ongoing
Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-9.
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lot # AD96184, Exp Date: 12/31/2026.
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- September 25, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0033-2027
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Class II Ongoing
Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Lots, distribution and details
- Lots / codes
- Lot: 07282026@2, BUD: 9/11/2026; 08032026@11, BUD: 9/17/2026; 08042026@3, BUD: 9/18/2026. .
- Distribution
- Nationwide within the U.S
- Quantity
- 20 mLs – in patient specific syringe dose
- Recall started
- September 10, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0032-2027
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Class II Ongoing
Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29…
Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Lots, distribution and details
- Product
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
- Lots / codes
- Lot: 07212026@1, BUD: 9/10/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 10 ml -in patient specific syringe dose
- Recall started
- September 10, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0031-2027
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Class II Ongoing
TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 299…
Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Lots, distribution and details
- Product
- TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936;
- Lots / codes
- Lot:07212026@9, BUD: 9/4/2026; 07252026@2, BUD: 9/8/2026; 08122026@14, BUD: 9/26/2026; 08272026@8, BUD: 10/11/2026; 08312026@18, BUD: 10/15/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 30.4 mLs – in patient specific syringe dose
- Recall started
- September 10, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0030-2027
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Class II Ongoing
TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 299…
Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Lots, distribution and details
- Product
- TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
- Lots / codes
- Lot:08032026@23, BUD: 9/17/2026; 08172026@19, BUD: 10/1/2026; 08262026@13, BUD: 10/10/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 24.8 mLs -in patient specific syringe dose
- Recall started
- September 10, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0029-2027
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Class II Ongoing
TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 299…
Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Lots, distribution and details
- Product
- TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
- Lots / codes
- Lot:07252026@3, BUD: 9/8/2026; 08112026@5, BUD: 9/25/2026; 08212026@21, BUD: 10/5/2026; 08282026@3, BUD: 10/12/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 29.6 mls – in patient specific syringe dose
- Recall started
- September 10, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0028-2027
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Class II Ongoing
TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 299…
Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Lots, distribution and details
- Product
- TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
- Lots / codes
- Lot:07212026@18, BUD: 9/4/2026; 07222026@14, BUD: 9/5/2026; 07292026@8, BUD: 9/12/2026; 08052026@14, BUD: 9/19/2026; 08142026@1, BUD: 9/28/2026; 08192026@10, BUD: 10/3/2026; 08242026@25, BUD: 10/8/2026; 08282026@2, BUD: 10/12/2026; 08292026@1, BUD:10/13/2026;
- Distribution
- Nationwide within the U.S
- Quantity
- 297 mL – in patient specific syringe dose
- Recall started
- September 10, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0027-2027
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Class II Ongoing
SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 2993…
Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Lots, distribution and details
- Product
- SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
- Lots / codes
- Lot: 07242026@1, BUD: 9/7/2026; 08032026@20, BUD: 9/17/2026; 08312026@16, BUD: 10/15/2026; 08242026@28, BUD: 10/8/2026; 08072026@16, BUD: 9/21/2026. .
- Distribution
- Nationwide within the U.S
- Quantity
- 82.9 mls – in patient specific syringe dose
- Recall started
- September 10, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0026-2027
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Class II Ongoing
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29…
Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Lots, distribution and details
- Product
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
- Lots / codes
- Lot:08062026@10, BUD: 9/20/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 5 mL in patient specific syringe dose
- Recall started
- September 10, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0025-2027
-
Class II Ongoing
Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 2…
Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Lots, distribution and details
- Product
- Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
- Lots / codes
- Lot:08042026@8, BUD: 9/18/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 3 ML in patient specific syringe dose
- Recall started
- September 10, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0024-2027
-
Class II Ongoing
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29…
Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Lots, distribution and details
- Product
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936,
- Lots / codes
- Lot: 07242026@7, BUD: 09/7/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 5 mL in patient specific syringe doses
- Recall started
- September 10, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0023-2027
-
Class II Ongoing
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29…
Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Lots, distribution and details
- Product
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936,
- Lots / codes
- Lot: 08072026@2, BUD:9/21/2026; 08032026@10, BUD:09/17/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 15 mLs – in patient specific syringe doses
- Recall started
- September 10, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0022-2027
-
Class II Ongoing
QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Lots, distribution and details
- Lots / codes
- LOT: 08032026@24, BUD: 09/17/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 5 mls in patient specific syringe doses
- Recall started
- September 10, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0021-2027
-
Class II Ongoing
SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland
Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Lots, distribution and details
- Lots / codes
- Lot: 07292026@12, BUD 09/12/2026; 07302026@7, BUD 09/13/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 15 mls – in patient specific syringe doses
- Recall started
- September 10, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0020-2027
-
Class II Ongoing
SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 2993…
Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Lots, distribution and details
- Product
- SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
- Lots / codes
- Lot: 07282026@3, BUD: 9/11/2026; 08252026@9, BUD: 10/9/2026; 08042026@12, BUD: 9/18/2026; 08072026@15, BUD: 9/21/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 57.0 mls – in patient specific syringe doses
- Recall started
- September 10, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0019-2027
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.