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
Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1
Reason: cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Lots, distribution and details
- Lots / codes
- Lot #: 1564-103, Exp 9/30/2024
- Distribution
- USA nationwide
- Quantity
- 8 vials involved in recall (16,479 vials distributed)
- Recall started
- February 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0340-2024
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Class II Ongoing
Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippan…
Reason: Failed Impurities/Degradation Specification: Out of specification for organic impurities
Lots, distribution and details
- Product
- Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57
- Lots / codes
- lOTS #: 22121458, 22121459, 22121460, 22121461, 22121462, 22121463, 22121464, Exp 4/2024; 22121176, 22121407, 22121465, Exp 3/2024; 22121761, 22121762, 22121763, 22121764, 22121766, 22121968, 22121969, Exp 5/2024.
- Distribution
- Nationwide in the USA
- Quantity
- 71,244 sachets
- Recall started
- January 16, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0339-2024
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Class II Terminated
Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park, Pittsburg, PA 15238 USA, www.airscent.com, NDC 75009-562.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot # 2022-012884 Lot # 2023-002020 Lot # 2023-003532 Lot # 2023-003761
- Distribution
- Product was distributed to two accounts in NC and MI
- Quantity
- 676 gallons
- Recall started
- January 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0338-2024
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Class II Terminated
Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufac…
Reason: Labeling: Incorrect or Missing Package Insert
Lots, distribution and details
- Product
- Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202. NDC: 43386-038-60.
- Lots / codes
- Lot#: S200756; Exp. 10/2024 Lot#: S300218; Exp. 04/2025 Lot#: S300633; Exp. 09/2025
- Distribution
- OH, IL, NJ
- Quantity
- N/A
- Recall started
- February 5, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0337-2024
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Class II Ongoing
Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20
Reason: Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Lots, distribution and details
- Product
- Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20
- Lots / codes
- Lot 23I21G64; Exp. 07/31/2024
- Distribution
- Nationwide in the USA
- Quantity
- 13,000 bags
- Recall started
- January 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0336-2024
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Class I Ongoing
Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
Reason: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide in the USA
- Quantity
- 4,932 boxes
- Recall started
- January 12, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0335-2024
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Class I Ongoing
Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
Reason: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide in the USA
- Quantity
- 117,000 bottles
- Recall started
- January 12, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0334-2024
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Class I Ongoing
Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
Reason: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Lots, distribution and details
- Lots / codes
- All lots
- Distribution
- Nationwide in the USA
- Quantity
- 1,000,000 bottles
- Recall started
- January 12, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0333-2024
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Class II Terminated
Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, item number 20000463, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
Reason: CGMP Deviations: Potential Glass and Silicone particulates in product
Lots, distribution and details
- Lots / codes
- a) 100041954, Exp 12/31/2026; b) 100042048, 100042060, Exp 12/31/2026
- Distribution
- Nationwide in the US
- Quantity
- a) 1597 cases/ 12 pack each b) 73 cases/4 pack each
- Recall started
- January 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0332-2024
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Class II Terminated
Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
Reason: CGMP Deviations: Potential Glass and Silicone particulates in product
Lots, distribution and details
- Lots / codes
- 100042290, Exp 12/31/2026
- Distribution
- Nationwide in the US
- Quantity
- 46 cases/6 pack each
- Recall started
- January 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0331-2024
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Class II Terminated
Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
Reason: CGMP Deviations: Potential Glass and Silicone particulates in product
Lots, distribution and details
- Lots / codes
- 100042238, Exp 12/31/2026
- Distribution
- Nationwide in the US
- Quantity
- 21 cases/4 pack each
- Recall started
- January 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0330-2024
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Class II Terminated
Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
Reason: CGMP Deviations: Potential Glass and Silicone particulates in product
Lots, distribution and details
- Lots / codes
- 100042236, Exp 12/31/2026
- Distribution
- Nationwide in the US
- Quantity
- 16 cases/4 pack each
- Recall started
- January 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0329-2024
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Class II Terminated
CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
Reason: CGMP Deviations: Potential Glass and Silicone particulates in product
Lots, distribution and details
- Lots / codes
- 100042059, Exp 12/31/2026
- Distribution
- Nationwide in the US
- Quantity
- 78 cases/18 packs each
- Recall started
- January 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0328-2024
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Class II Terminated
Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6
Reason: Failed Impurities/Degradation Specifications: Out-of-specification test results.
Lots, distribution and details
- Lots / codes
- Lot # BF22722A, Exp. 08/31/2024; BJ15122A, Exp. 09/30/2024
- Distribution
- Nationwide in the USA
- Quantity
- 46,037 Bottles
- Recall started
- February 13, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0327-2024
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Class II Ongoing
Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays – 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1
Reason: CGMP Deviations: potential presence of Burkholderia cepacia complex
Lots, distribution and details
- Product
- Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays – 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1
- Lots / codes
- Lot number # TX5274 Exp. 09/30/2026
- Distribution
- Nationwide in the USA
- Quantity
- 292,752 bottles
- Recall started
- February 9, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0326-2024
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Class II Ongoing
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71…
Reason: Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Lots, distribution and details
- Product
- Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1.
- Lots / codes
- Lot #s: 20230929VAS-2, Exp. 02/29/2024; 20231004VAS-2, Exp. 04/01/2024; Lot 20231010VAS-2,Exp. 04/07/2024; Lot 20231013VAS-2, Exp. 04/10/2024
- Distribution
- MN
- Quantity
- 1,299 syringes
- Recall started
- January 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0325-2024
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Class II Terminated
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10×10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia M…
Reason: an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Lots, distribution and details
- Product
- HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10×10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
- Lots / codes
- Lot #: T04680, Exp. Date 6/2024
- Distribution
- The product was distributed nationwide within the United States.
- Quantity
- 8,198 units
- Recall started
- February 9, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0324-2024
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Class III Ongoing
Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North…
Reason: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Lots, distribution and details
- Product
- Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58
- Lots / codes
- Lot #: 100040731, Exp 7/31/2024
- Distribution
- nationwide
- Quantity
- 19,824 cartons
- Recall started
- January 25, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0322-2024
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Class III Ongoing
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454,…
Reason: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Lots, distribution and details
- Product
- Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67
- Lots / codes
- Lot #: 100042978, Exp 7/31/2024
- Distribution
- nationwide
- Quantity
- 12,916 cartons
- Recall started
- January 25, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0321-2024
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Class III Terminated
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11
Reason: Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Lots, distribution and details
- Product
- HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11
- Lots / codes
- Lot #: 1012275, Exp 02/28/2025
- Distribution
- Nationwide in the USA
- Quantity
- 2,850 cartons
- Recall started
- February 1, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0320-2024
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Class II Terminated
Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC,…
Reason: Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Lots, distribution and details
- Product
- Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01
- Lots / codes
- Lot # AM221153, Exp. date 06/30/2024; AM230497, Exp. date 02/29/2025
- Distribution
- USA nationwide.
- Quantity
- 858 bottles
- Recall started
- January 15, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0319-2024
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Class II Terminated
Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
Reason: CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
Lots, distribution and details
- Lots / codes
- Lot # 411987 Exp: 05/2025
- Distribution
- Nationwide in the USA
- Quantity
- 4260 bottles
- Recall started
- February 1, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0318-2024
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Class II Ongoing
Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 53329-147-44
Reason: Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Lots, distribution and details
- Product
- Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 53329-147-44
- Lots / codes
- Lot #s: 08926; 08926A Exp. 8/2025; 08928 Exp. 9/2025
- Distribution
- Nationwide in the USA
- Quantity
- 1,786 tubes
- Recall started
- January 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0315-2024
-
Class II Terminated
Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11
- Lots / codes
- Lot # 1015033, exp. 06/30/2025; 1016409, exp. 08/31/2025
- Distribution
- USA Nationwide
- Quantity
- 1,932 cartons
- Recall started
- January 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0314-2024
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Class III Ongoing
Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05
Reason: Misprint on tablet
Lots, distribution and details
- Lots / codes
- Lot: T2303609; Exp. 06/2026 Lot: T2303610; Exp. 06/2026
- Distribution
- Nationwide
- Quantity
- 14,425 bottles
- Recall started
- January 18, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0313-2024
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 4, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.