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.
3 Class I (most serious) drug recalls reported in the last 30 days.
3,250 recalls
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Class II Ongoing
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee,…
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Product
- Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0779-2023
-
Class II Ongoing
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2
Reason: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Lots, distribution and details
- Product
- HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2
- Lots / codes
- Lot #: 20230222-45AB24, BUD: 8/21/2023; Lot #: 20230110-058361, BUD: 7/9/2023; Lot #: 20221208-0F5483, BUD: 6/6/2023; Lot #: 20221109-45BA60, BUD: 5/8/2023; Lot #:20220929-523FD5, BUD: 3/28/2023; Lot#: 20220914-5D5AE0, BUD: 3/13/2023; Lot #: 220502-024, BUD: 10/29/2022; Lot #: 220510-035, BUD: 11/6/2022; Lot #: 220526-015, BUD: 11/22/2022; Lot#: 220811-010, BUD: 2/7/2023
- Distribution
- Product was distributed in Missouri.
- Quantity
- 3,232 syringes
- Recall started
- May 9, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0776-2023
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Class II Ongoing
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Lots, distribution and details
- Lots / codes
- Lot 8639, Exp: 8/2023
- Distribution
- Product was distributed Nationwide.
- Quantity
- 13,968 bottles
- Recall started
- May 3, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0775-2023
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Class II Ongoing
Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 Strawberry Field Road, Warwick, RI 05886. NDC 70309-080-02
Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Lots, distribution and details
- Lots / codes
- Lot 8640, Exp: 11/2023
- Distribution
- Product was distributed Nationwide.
- Quantity
- 4,812 units
- Recall started
- May 3, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0774-2023
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Class II Ongoing
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Lots, distribution and details
- Lots / codes
- Lot 8290V, Exp: 10-2023
- Distribution
- Product was distributed Nationwide.
- Quantity
- 54,222 bottles
- Recall started
- May 3, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0773-2023
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Class II Ongoing
Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Lots, distribution and details
- Lots / codes
- Lot: 8314, Exp: 04/2023, 8753, 8753A, Exp: 10/2023; 8659, Exp: 08-2023
- Distribution
- Product was distributed Nationwide.
- Quantity
- 86,616 4 OZ bottles
- Recall started
- May 3, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0772-2023
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Class II Ongoing
Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64.
Reason: Sub-potent Drug
Lots, distribution and details
- Lots / codes
- Lot: 1643397 BUD: 10/16/2023
- Distribution
- Nationwide in the US
- Quantity
- 45 Vials
- Recall started
- May 11, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0771-2023
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Class II Ongoing
Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99
- Lots / codes
- Lot: NFT101, EXP: 5/31/2024; Lots: NFT201, NFT202, EXP: 2/28/2025; Lots: NFT203, NFT204, EXP: 5/31/2025
- Distribution
- Nationwide USA
- Quantity
- 370,200 bottles
- Recall started
- May 19, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0764-2023
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Class II Ongoing
Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10
- Lots / codes
- Lots: NFL101, NFL102, EXP: 1/31/2024; Lots: NFL103, NFL104, EXP: 5/31/2024; Lot: NFL201, EXP: 03/31/2025; Lot: NFL202, EXP: 5/31/2025;
- Distribution
- Nationwide USA
- Quantity
- 2,249,980 vials
- Recall started
- May 19, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0763-2023
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Class II Ongoing
Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10
- Lots / codes
- Lot: NFG101, EXP: 1/31/2024; Lot: NFG102, EXP: 9/30/2024; Lot: NFG201, 5/31/2025
- Distribution
- Nationwide USA
- Quantity
- 2,249,980 vials
- Recall started
- May 19, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0762-2023
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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
FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: AC-016644, Exp. Date 05/08/2023; AC-016659, Exp. Date 09/26/2023
- Distribution
- Missouri only
- Quantity
- 308 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-0646-2023
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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
Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-500-25
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: AC-016640, Exp. Date 06/16/2023; AC-016670, Exp. Date 08/29/2023
- Distribution
- Missouri only
- Quantity
- 682 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-0644-2023
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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
-
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
-
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
-
Class II Ongoing
Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-550-25
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot#: AC-016631, Exp. Date 05/29/2023; AC-016655, Exp. Date 08/07/2023
- Distribution
- Missouri only
- Quantity
- 1617 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-0637-2023
-
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
-
Class II Ongoing
Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-050-05
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: AC-016627, Exp. Date 06/17/2023; AC-016635, Exp. Date 07/08/2023; AC-016662, Exp. Date 09/30/2023
- Distribution
- Missouri only
- Quantity
- 2040 syringes
- 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-0635-2023
-
Class II Ongoing
FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-910-25
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: AC-016624, Exp. Date 06/10/2023
- Distribution
- Missouri only
- Quantity
- 790 syringes
- 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-0634-2023
-
Class II Ongoing
Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-020-05
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: AC-016607, Exp. Date 05/09/2023
- Distribution
- Missouri only
- Quantity
- 90 syringes
- 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-0633-2023
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 November 5, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.