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 III Ongoing
Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepa…
Reason: Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Lots, distribution and details
- Product
- Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9207-1.
- Lots / codes
- Lot: 235067, Exp 12/31/2025; 235289, Exp 11/30/2025; 235290, Exp 12/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 61 Bottles
- Recall started
- May 10, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0540-2024
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Class III Ongoing
Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch P…
Reason: Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
Lots, distribution and details
- Product
- Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9206-1.
- Lots / codes
- Lot: 235288, 235294, 235368, 235806, 236058, 236138, 236139, 236351, 236490, 236757, 236877, Exp:11/30/2025; 236758, 236762, 237254, 237349, 237401, 237807, Exp: 12/31/2025.
- Distribution
- Nationwide in the USA
- Quantity
- 190 bottles
- Recall started
- May 10, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0539-2024
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Class III Ongoing
Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prep…
Reason: Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Lots, distribution and details
- Product
- Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-8858-1.
- Lots / codes
- Lot: 235287, 235629, 235805, 236292, 237022, 237308, 237748, Exp: 12/31/2025;
- Distribution
- Nationwide in the USA
- Quantity
- 104 bottles
- Recall started
- May 10, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0538-2024
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Class III Ongoing
Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactured by Alkem Laborat…
Reason: Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Lots, distribution and details
- Product
- Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9205-1.
- Lots / codes
- Lot:234892, Exp:02/28/2025.
- Distribution
- Nationwide in the USA
- Quantity
- 6 bottles
- Recall started
- May 10, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0537-2024
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Class III Ongoing
Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1.
Reason: Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Lots, distribution and details
- Lots / codes
- Lot:225541, 226866, 227369, 227519, 229845, 231422, 234889, Exp: 03/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 156 bottles
- Recall started
- May 10, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0536-2024
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Class II Ongoing
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06
Reason: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Lots, distribution and details
- Lots / codes
- Lot#: 19223402; Exp. 7/2024 Lot#: 19224858; Exp. 11/2024 Lot#: 19232492; Exp. 6/2025
- Distribution
- US Nationwide.
- Quantity
- 13296 cartons
- Recall started
- May 13, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0535-2024
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Class II Ongoing
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-467-06
Reason: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Lots, distribution and details
- Lots / codes
- Lot#: 19224857; Exp. 11/2024 Lot#: 19232493; Exp. 6/2025
- Distribution
- US Nationwide.
- Quantity
- 2400 cartons
- Recall started
- May 13, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0534-2024
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Class II Ongoing
Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99
Reason: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Lots, distribution and details
- Lots / codes
- Lot#: 19224217; Exp. 9/2024 Lot#: 19233789; Exp. 9/2025 Lot#: 19224444; Exp. 9/2024
- Distribution
- US Nationwide.
- Quantity
- 11,976 cartons
- Recall started
- May 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0533-2024
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Class II Ongoing
Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99
Reason: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Lots, distribution and details
- Lots / codes
- Lot#: 19233788; Exp. 9/2025 Lot#: 19224445; Exp. 9/2024
- Distribution
- US Nationwide.
- Quantity
- 3,480 cartons
- Recall started
- May 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0532-2024
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Class II Terminated
EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Roa…
Reason: Lack of Assurance of Sterility: Complaints of syringe breakage
Lots, distribution and details
- Product
- EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01, NDC (sample lot) 61755-005-54
- Lots / codes
- Lot # 8231500321, Exp. date Oct-24 8231500335, Exp. date Jan-25 8231500333, Exp. date Jan-25 8231500334, Exp. date Jan-25 8231500339, Exp. date Jan-25 8231500347, Exp. date Jan-25 8231500336, Exp. date Jan-25 8231500337, Exp. date Jan-25 8231500340, Exp. date Jan-25 8268700014 (sample lot) exp. date Jan-25
- Distribution
- USA nationwide.
- Quantity
- 405,725 Prefilled syringes
- Recall started
- May 15, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0531-2024
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Class II Ongoing
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 4 OZ (113g), Manufactured for AGS Brands. UPC 0 17971 10421…
Reason: Out of Specification for active ingredient
Lots, distribution and details
- Product
- ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 4 OZ (113g), Manufactured for AGS Brands. UPC 0 17971 10421 7
- Lots / codes
- Lot 04023C1 Exp 01/31/2025
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 6,264
- Recall started
- April 17, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0530-2024
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Class II Ongoing
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Roll-On NET WT 3 fl. oz. (88.7ml), Manufactured for Golden Tiger USA Albuquerque, NM, UPC 1 82294…
Reason: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Lots, distribution and details
- Product
- NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Roll-On NET WT 3 fl. oz. (88.7ml), Manufactured for Golden Tiger USA Albuquerque, NM, UPC 1 82294 00006 2
- Lots / codes
- Lot 17323C3, Exp 06/30/2025
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 1,680
- Recall started
- April 17, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0529-2024
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Class II Ongoing
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Roll-On 3 fl oz (88.7ml), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO 8…
Reason: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Lots, distribution and details
- Product
- Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Roll-On 3 fl oz (88.7ml), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00010 9
- Lots / codes
- Lot 17323C3, Exp 06/30/2025
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 3,504
- Recall started
- April 17, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0528-2024
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Class II Ongoing
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Tube 4 oz (113.39 g), Mfr. for Golden Tiger USA Albuq, NM, UPC 1 82294 00002 4
Reason: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Lots, distribution and details
- Lots / codes
- Lot 01623C1, Exp 01/31/2025
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 3,000
- Recall started
- April 17, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0527-2024
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Class II Ongoing
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark & MSM, Bottle with Pump NET WT 32 fl. oz (946.33ml), Manufactured for Golden Tiger LLC Made in USA,…
Reason: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Lots, distribution and details
- Product
- NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark & MSM, Bottle with Pump NET WT 32 fl. oz (946.33ml), Manufactured for Golden Tiger LLC Made in USA, UPC 1 82294 00004 8
- Lots / codes
- Lot 01823C2, 01823C1, Exp 01/31/2025
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 500
- Recall started
- April 17, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0526-2024
-
Class II Ongoing
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 4oz (113.39g), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO…
Reason: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Lots, distribution and details
- Product
- Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 4oz (113.39g), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00019 2
- Lots / codes
- Lot , 06023C1, Exp 01/31/2025,
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 2,864
- Recall started
- April 17, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0525-2024
-
Class II Ongoing
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 8 oz (226.79g), Made in the USA, painwizard.com PO Box 1099, Johnstown, C…
Reason: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Lots, distribution and details
- Product
- Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 8 oz (226.79g), Made in the USA, painwizard.com PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00011 6
- Lots / codes
- Lots 19823C4, EXP 07/31/2025; 01623C1, Exp 01/31/2025
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 7,410
- Recall started
- April 17, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0524-2024
-
Class II Ongoing
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), Manufactured for AGS Brands.
Reason: Out of Specification for active ingredient
Lots, distribution and details
- Product
- ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), Manufactured for AGS Brands.
- Lots / codes
- Lot 04023C1, Exp 01/31/2025
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 4,013
- Recall started
- April 17, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0523-2024
-
Class II Ongoing
Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW WT. 5 FL OZ (148ML), Distributed by: Bullfrog Brands LLC, PO Box 600207, Dallas, TX…
Reason: Out of Specification for active ingredient
Lots, distribution and details
- Product
- Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW WT. 5 FL OZ (148ML), Distributed by: Bullfrog Brands LLC, PO Box 600207, Dallas, TX 75360 USA. UPC 8 50016 52112 5
- Lots / codes
- Lot 08623C2, 08923C2, Exp 03/31/2026
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 9,697
- Recall started
- April 17, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0522-2024
-
Class II Ongoing
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Gallon Jug 128 fl. oz. (3776 ml), Manufactured for Golden Tiger LLC, Made in USA, UPC 1 82294 00…
Reason: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Lots, distribution and details
- Product
- NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Gallon Jug 128 fl. oz. (3776 ml), Manufactured for Golden Tiger LLC, Made in USA, UPC 1 82294 00005 5
- Lots / codes
- Lot: 01823C2, Exp 01/31/2025
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 192
- Recall started
- April 17, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0521-2024
-
Class II Ongoing
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Bottle with pump, NET WT 16 fluid oz / 473.17 ml, Made in USA, www.painwizard.com Pain…
Reason: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Lots, distribution and details
- Product
- Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Bottle with pump, NET WT 16 fluid oz / 473.17 ml, Made in USA, www.painwizard.com Pain Wizard LLC.PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00012 3
- Lots / codes
- Lot: 18723C3, Exp 06/30/2025
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 3,440
- Recall started
- April 17, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0520-2024
-
Class II Ongoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 23JUL025, Exp. Date 7/17/2024; 23SEP012, Exp. Date 7/11/2024; 23OCT015, Exp. Date 7/20/2024; 23OCT020, Exp. Date 7/25/2024; 23OCT026, Exp. Date 8/22/2024; 23NOV030, Exp. Date 8/29/2024, 23DEC026, Exp. Date 9/29/2024; 24JAN011, Exp. Date 7/21/2024; 24FEB033, Exp. Date 8/24/2024; 24JAN050, Exp. Date 8/30/2024
- Distribution
- Nationwide within the United States
- Quantity
- 74,440 units
- Recall started
- May 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0519-2024
-
Class II Terminated
Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-…
Reason: Defective container: lack of seal integrity.
Lots, distribution and details
- Product
- Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04
- Lots / codes
- Lot #F305184, F305185, F305186, Exp 7/31/ 2025
- Distribution
- USA Nationwide
- Quantity
- 51,006 bottles
- Recall started
- May 8, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0518-2024
-
Class II Ongoing
Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00
Reason: Presence of Foreign Substance: metal in tablet
Lots, distribution and details
- Lots / codes
- Lot 231037H1, exp 6/2027
- Distribution
- Nationwide
- Quantity
- 11,664 Bottles
- Recall started
- May 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0517-2024
-
Class II Ongoing
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 23JUN003, Exp. Date 5/29/2024; 23JUL035, Exp. Date 7/24/2024; 23AUG033, Exp. Date 8/14/2024; 23AUG043, Exp. Date 8/21/2024; 23SEP001, Exp. Date 9/26/2024; 23OCT002, Exp. Date 10/4/2024; 23OCT031, Exp. Date 10/31/2024; 23NOV011, Exp. Date 11/28/2024; 24FEB027, Exp. Date 2/15/2025
- Distribution
- Nationwide within the United States
- Quantity
- 165,920 vials
- Recall started
- May 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0516-2024
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 3, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.