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.
22 recalls
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Class III Ongoing
Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-1
Reason: Subpotent drug
Lots, distribution and details
- Lots / codes
- Lot 23G3161005, Exp 9/21/2027
- Distribution
- Nationwide in the USA, Belgium and France
- Quantity
- 36 bottles
- Recall started
- March 31, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0488-2026
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Class I Ongoing
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed…
Reason: Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Lots, distribution and details
- Product
- Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1720-3.
- Lots / codes
- Lot: AH250162, Exp 8/31/2027
- Distribution
- U.S.A. Nationwide
- Quantity
- 784 (12x100mL) cartons
- Recall started
- March 18, 2026 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0478-2026
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Class II Ongoing
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
Reason: Failed Disintegration Specifications: above the time expected.
Lots, distribution and details
- Lots / codes
- Lot#: PWXT, Exp 1/31/2027
- Distribution
- CA and HI
- Quantity
- 3,640 bottles
- Recall started
- December 19, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0298-2026
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Class II Ongoing
Magnesium Chloride 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
- 430
- 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-0062-2026
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Class II Ongoing
Glutathione Magnesium for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- All lots within expiry.
- Distribution
- US Nationwide.
- Quantity
- —
- 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-0052-2026
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Class II Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA)…
Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Lots, distribution and details
- Product
- Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94
- Lots / codes
- Lot #:M402147, Exp 10/2025; M311637, Exp 07/2025; M402495, Exp 02/2026; M407997, Exp 05/2026; M502246, Exp11/2026.
- Distribution
- Nationwide -in the USA
- Quantity
- 22,152 30 sachets/carton
- Recall started
- May 13, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0443-2025
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Class II Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA)…
Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Lots, distribution and details
- Product
- Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94
- Lots / codes
- Lot # M311638, Exp 07/2025, M400374, Exp 10/2025, M402496, Exp 02/2026, M407998, Exp 05/2026, M502247, Exp 11/2026, M414770, M414512, Exp 09/2026.
- Distribution
- Nationwide -in the USA
- Quantity
- 30,674 30 sachets/carton
- Recall started
- May 13, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0442-2025
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Class III Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington,…
Reason: Labeling: Not Elsewhere Classified – Wrong NDC number
Lots, distribution and details
- Product
- Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets
- Lots / codes
- Lot#: M408002, Exp 05/31/2026
- Distribution
- USA Nationwide.
- Quantity
- 4404 packs
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0102-2025
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Class II Ongoing
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitone…
Reason: This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Lots, distribution and details
- Product
- DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94
- Lots / codes
- 24AU03024, exp. date 07/31/2025
- Distribution
- Nationwide
- Quantity
- 183 cases
- Recall started
- June 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0608-2024
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Class II Ongoing
Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle, Distributed by: Meijer Distribution Inc., Grand Rapids,MI 49544, NDC 79481-0034-9
Reason: Microbial Contamination of Non-Sterile Products – Presence of Acetobacter nitrogenifigens bacteria
Lots, distribution and details
- Lots / codes
- Lot #: A81834, Exp 1/31/2026
- Distribution
- USA Nationwide
- Quantity
- 24840
- Recall started
- May 1, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0501-2024
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Class II Ongoing
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.
Reason: Microbial Contamination of Non-Sterile Products – Presence of Acetobacter nitrogenifigens bacteria
Lots, distribution and details
- Lots / codes
- Lot #: A81506, Exp 12/31/2025
- Distribution
- USA Nationwide
- Quantity
- 120830
- Recall started
- May 1, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0500-2024
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Class II Ongoing
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Cherry Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr., Texarkana, TX 75501, NDC 82645-312-10.
Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS – Presence of Acetobacter nitrogenifigens bacteria.
Lots, distribution and details
- Lots / codes
- Lot A80622; Exp. 11/2025
- Distribution
- Nationwide.
- Quantity
- 7,404 Bottles
- Recall started
- December 21, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0231-2024
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Class II Ongoing
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr., Texarkana, TX 75501, NDC 82645-311-10.
Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS – Presence of Acetobacter nitrogenifigens bacteria.
Lots, distribution and details
- Lots / codes
- Lot A80553; Exp. 11/2025
- Distribution
- Nationwide.
- Quantity
- 53,268 Bottles
- Recall started
- December 21, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0230-2024
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Class II Ongoing
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Flavor 10 fl. oz, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.
Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS – Presence of Acetobacter nitrogenifigens bacteria.
Lots, distribution and details
- Lots / codes
- Lot A80763; Exp. 11/2025
- Distribution
- Nationwide.
- Quantity
- 13,344 bottles
- Recall started
- December 21, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0229-2024
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Class II Ongoing
Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Free Low Sodium, Grape flavor 10 fl. oz, Distributed by: Walgreen Co, 200 Wilmot Rd, Deerfield, IL 60015, NDC 0363-0427-98.
Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS – Presence of Acetobacter nitrogenifigens bacteria.
Lots, distribution and details
- Lots / codes
- Lot A80623; Exp. 11/30/2025
- Distribution
- Nationwide.
- Quantity
- 49,716 Bottles
- Recall started
- December 21, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0228-2024
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Class II Ongoing
Good Neighbor Pharmacy, DYE FREE, SUGAR FREE Magnesium Citrate Saline Laxative, Oral Solution, Cherry Flavor 10 fl. oz, Distributed by AmerisourceBergen, 1 West First Ave, Conshochoken, PA 19428, NDC 46122-741-38
Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS – Presence of Acetobacter nitrogenifigens bacteria.
Lots, distribution and details
- Lots / codes
- Lots A80673, A80742; Exp 10/31/2025
- Distribution
- Nationwide.
- Quantity
- 24,684 Bottles
- Recall started
- December 21, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0227-2024
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Class III Terminated
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwa…
Reason: Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
Lots, distribution and details
- Product
- Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,
- Lots / codes
- Lot # 17220002, Exp Date 11/30/2023
- Distribution
- Nationwide in the USA
- Quantity
- 8,448 30-count bottles, 168 1000-count bottles
- Recall started
- October 23, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0112-2024
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Class II Ongoing
Myers Cocktail #5 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosp…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Myers Cocktail #5 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg + Folic Acid 1 mg + Vitamin E Succinate 10 IU + Vitamin A Acetate 100 IU/10-mL), (10 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): 07182016A (12/31/2016)
- Distribution
- Nationwide
- Quantity
- 21 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-0275-2017
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Class II Ongoing
Myers Cocktail #4 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosp…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Myers Cocktail #4 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg/10-mL), (10 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): 06202016DD (06/21/2016), 09132016B (02/28/2017)
- Distribution
- Nationwide
- Quantity
- 66 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-0274-2017
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Class II Ongoing
Calm Me (Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride 50 mg/Taurine 50 mg/Theanine (L) 50 mg/Tryptophan (L) 10 mg/Lidocaine HCL 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Calm Me (Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride 50 mg/Taurine 50 mg/Theanine (L) 50 mg/Tryptophan (L) 10 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): 09212016A (01/31/2017), 08032016C (01/31/2017).
- Distribution
- Nationwide
- Quantity
- 10 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-0255-2017
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Class I Ongoing
Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 21…
Reason: Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
Lots, distribution and details
- Product
- Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
- Lots / codes
- Lot #: 50-343-DK*, Exp 01FEB2017; note that the lot number may be followed by numbers from 01 to 99.
- Distribution
- Nationwide, United Arab Emirates, Kuwait, and Bahrain
- Quantity
- 88,500 vials
- Recall started
- March 23, 2016 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-1137-2016
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Class III Ongoing
Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 21…
Reason: Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
Lots, distribution and details
- Product
- Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
- Lots / codes
- Lot #: 42-335-DK, Exp 1JUN2016; 48-128-DK, 48-129-DK, 48-261-DK, 48-262-DK, 48-351-DK, Exp 1DEC2016; 52-361-DK, Exp 1APR2017; note that the lot number may be followed by numbers from 01 to 99.
- Distribution
- Nationwide, Puerto Rico, United Arab Emirates, Israel, Kuwait, Bahrain, and Trinidad & Tobago
- Quantity
- 715,200 vials
- Recall started
- March 23, 2016 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0854-2016
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.