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.
29 recalls
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Class II Ongoing
Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3583-01.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot # NC193894, Exp Date: 04/25/2027.
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- Quantity
- N/A
- Recall started
- August 6, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0820-2026
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Class II Ongoing
Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot # NC188678, Exp Date: 12/1/2026; Lot # NC188814, Exp Date: 12/5/2026; Lot # NC188944, Exp Date: 12/8/2026; Lot # NC193610, Exp Date: 4/21/2027, Lot # NC193665, Exp Date: 4/23/2027.
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- Quantity
- N/A
- Recall started
- August 6, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0805-2026
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Class II Ongoing
Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Lots, distribution and details
- Lots / codes
- Lot: C274-000050987, Exp.:7/12/2026; C274-000049425, Exp.: 5/2/2026; C274-000050069, Exp.: 5/30/2026; C274-000050346, Exp.: 6/10/2026; C274-000050698, Exp.: 6/27/2026; C274-000050699, Exp.:6/27/2026; C274-000050775, Exp.:7/4/2026.
- Distribution
- Nationwide in the U.S.A.
- Quantity
- 11,680 bags
- Recall started
- March 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0442-2026
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Class II Ongoing
Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Lots, distribution and details
- Lots / codes
- Lot: C274-000050858, Exp.:7/6/2026; C274-000051018, Exp.: 7/13/2026; C274-000049194, Exp.: 4/20/2026; C274-000049591, Exp.: 5/9/2026; C274-000049592, Exp.: 5/9/2026; C274-000049823, Exp.: 5/18/2026; C274-000050301, Exp.: 6/8/2026; C274-000050411, Exp.: 6/13/2026; C274-000051056, Exp.:7/18/2026.
- Distribution
- Nationwide in the U.S.A.
- Quantity
- 16,130 bags
- Recall started
- March 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0441-2026
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Class II Ongoing
Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Lots, distribution and details
- Lots / codes
- Lot: C274-000050857, Exp.:7/6/2026; C274-000049316, Exp.: 4/26/2026; C274-000049367, Exp.: 4/28/2026; C274-000049496, Exp.: 5/3/2026; C274-000049518, Exp.: 5/4/2026; C274-000049535, Exp.: 5/5/2026; C274-000049653, Exp.: 5/11/2026; C274-000049654, Exp.: 5/11/2026; C274-000049745, Exp.: 5/16/2026; C274-000050128, Exp.: 5/31/2026; C274-000050151, Exp.: 6/1/2026; C274-000050184, Exp.: 6/6/2026; C274-000050504, Exp.: 6/15/2026; C274-000050662, Exp.: 6/21/2026; C274-000050836, Exp.: 7/5/2026; C274-000051014, Exp.: 7/13/2026; C274-000051057, Exp.: 7/18/2026; C274-000051240, Exp.: 7/25/2026.
- Distribution
- Nationwide in the U.S.A.
- Quantity
- 34,260 bags
- Recall started
- March 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0440-2026
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Class II Ongoing
vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot # C274-000047611, Exp Date: 10-Feb-26; Lot # C274-000049633, Exp Date: 12-May-26.
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- February 5, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0337-2026
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Class II Ongoing
vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot # C274-000049628, Exp Date: 3-May-26.
- Distribution
- US Nationwide.
- Quantity
- 1578 bags
- Recall started
- February 5, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0336-2026
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Class II Terminated
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
Reason: cGMP violations
Lots, distribution and details
- Lots / codes
- Lot # C274-000038004, exp. date 27-Nov-24
- Distribution
- Product was distributed to 125 direct accounts nationwide.
- Quantity
- 1082 bags
- Recall started
- September 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0018-2025
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Class I Terminated
Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal P…
Reason: Superpotent Drug: Due to overfilling of drug powder
Lots, distribution and details
- Product
- Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
- Lots / codes
- Lot # (a) 22613003A, Exp. date 09/30/2025; (b) 22613004A, 22613005A, Exp. date 09/30/2025; (c) 22613005B, Exp. date 09/30/2025
- Distribution
- Nationwide in the USA.
- Quantity
- 821 bottles
- Recall started
- March 21, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0442-2024
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Class II Terminated
VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 1223049049 Exp 12/28/23
- Distribution
- Nationwide in the USA
- Quantity
- 368 bags
- Recall started
- November 9, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0425-2024
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Class I Ongoing
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Lots, distribution and details
- Lots / codes
- Lot #: 2331140, Exp. Date 02/08/2024; 2331188, Exp. Date 02/15/2024; 2331261, Exp. Date 03/05/2024; 2331287, Exp. Date 03/14/2024.
- Distribution
- Nationwide within the United States
- Quantity
- 7,548 IV bags
- Recall started
- December 28, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0282-2024
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Class I Ongoing
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Lots, distribution and details
- Lots / codes
- Lot #: 2331184, Exp. Date 02/13/2024; 2331185, Exp. Date 02/10/2024; 2331189, Exp. Date 02/20/2024; 2331191, Exp. Date 02/24/2024; 2331258,Exp. Date 03/03/2024; 2331317, Exp. Date 03/15/2024.
- Distribution
- Nationwide within the United States
- Quantity
- 10,152 IV bags
- Recall started
- December 28, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0281-2024
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Class III Terminated
VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68.
Reason: Labeling: Not Elsewhere Classified
Lots, distribution and details
- Lots / codes
- Lot#: 2330792, Exp. 12/17/23; 2330801, Exp. 12/26/23; 2330821, 10/15/23; 2330823, Exp. 10/21/23; 2330825, Exp. 10/27/23; 2330846, Exp. 10/28/23; 2330847, Exp. 11/03/23; 2330856, 11/17/23; 2330858, Exp. 12/03/23; 2330860, 12/15/23; 2330866, Exp. 12/29/23; 2331053, Exp. 01/13/24.
- Distribution
- USA Nationwide
- Quantity
- 25,908 IV bags
- Recall started
- October 4, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0072-2024
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Class III Terminated
VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68.
Reason: Labeling: Not Elsewhere Classified
Lots, distribution and details
- Lots / codes
- Lot#: 2330781, Exp. 10/19/23; 2330791, Exp. 10/29/23; 2330795, Exp. 11/02/23; 2330800, Exp. 11/09/23; 2330807, Exp. 11/11/23; 2330812, Exp. 11/16/23; 2330816, Exp. 11/19/23; 2330822, 10/20/23; 2330897,11/23/23; 2330899, 11/25/23; 2330901, 11/26/23; 2330918, 11/30/23; 2330943, 01/12/24; 2331050, 01/14/24; 2331064, 01/21/24; 2331102, Exp. 01/25/24.
- Distribution
- USA Nationwide
- Quantity
- 33,480 IV Bags
- Recall started
- October 4, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0071-2024
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Class II Ongoing
VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: AC-016633, Exp. Date 05/24/2023; AC-016651, Exp. Date 07/22/2023
- Distribution
- Missouri only
- Quantity
- 646 bags
- Recall started
- May 2, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0647-2023
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Class II Ongoing
VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-255-25
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: AC-016632, Exp. Date 05/24/2023
- Distribution
- Missouri only
- Quantity
- 491 bags
- Recall started
- May 2, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0645-2023
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Class II Ongoing
VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-224-50
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: AC-016649, Exp. Date 07/01/2023
- Distribution
- Missouri only
- Quantity
- 54 bags
- Recall started
- May 2, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0643-2023
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Class II Ongoing
VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-204-50
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-204-50
- Lots / codes
- Lot #: AC-016638, Exp. Date 05/27/2023
- Distribution
- Missouri only
- Quantity
- 413 bags
- Recall started
- May 2, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0642-2023
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Class II Ongoing
VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-194-50
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: AC-016648, Exp. Date 07/01/2023
- Distribution
- Missouri only
- Quantity
- 240 bags
- Recall started
- May 2, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0641-2023
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Class II Ongoing
VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-254-25
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: AC-016641, Exp. Date 06/03/2023; AC-016653 Exp. Date 07/26/2023
- Distribution
- Missouri only
- Quantity
- 1622 bags
- Recall started
- May 2, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0640-2023
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Class II Ongoing
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-264-25
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: AC-016647, Exp. Date 06/28/2023
- Distribution
- Missouri only
- Quantity
- 1113 bags
- Recall started
- May 2, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0639-2023
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Class II Ongoing
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-284-25
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: AC-016647, Exp. Date 06/28/2023
- Distribution
- Missouri only
- Quantity
- 1113 bags
- Recall started
- May 2, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0638-2023
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Class II Ongoing
VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-185-50
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot#: AC-016629, Exp. Date 05/13/2023; AC-016646, Exp. Date 06/24/2023
- Distribution
- Missouri only
- Quantity
- 2040 bags
- Recall started
- May 2, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0636-2023
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Class II Ongoing
VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Reason: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lots, distribution and details
- Product
- VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Lots / codes
- Lots: 65432, BUD: 10/13/2022; 66347, BUD: 11/05/2022; 66864, BUD: 11/18/2022
- Distribution
- AL, LA, MS, and TN
- Quantity
- 12 syringes
- Recall started
- October 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0056-2023
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Class II Ongoing
Vancomycin 1.25 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29185, Discard After 05/23/14
Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Lots, distribution and details
- Lots / codes
- Rx # 29185, Exp 05/23/14
- Distribution
- Florida
- Quantity
- 14 units
- Recall started
- May 15, 2014 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1475-2014
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.