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
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
Reason: Failed Tablet/Capsule Specifications
Lots, distribution and details
- Product
- IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
- Lots / codes
- Lot #: C5406201, Exp 03/31/2028
- Distribution
- USA Nationwide
- Quantity
- 3416 botttles
- Recall started
- October 29, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0047-2025
-
Class II Ongoing
Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured by: Keystone Industries, 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC 68400-202-1…
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured by: Keystone Industries, 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC 68400-202-10
- Lots / codes
- Lot #: PVC-003015, Exp. Date Sep-21-2025; PVC-003061, Exp. Date Apr-30-2026
- Distribution
- Nationwide within the United States
- Quantity
- 787 pumps
- Recall started
- October 17, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0046-2025
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Class III Terminated
Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.
Reason: Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Lots, distribution and details
- Lots / codes
- Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025
- Distribution
- Nationwide in the US.
- Quantity
- 25814 tablets
- Recall started
- November 5, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0045-2025
-
Class II Ongoing
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90
Reason: Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Lots, distribution and details
- Lots / codes
- Lot# NB240873, Exp 03/31/2026
- Distribution
- USA nationwide.
- Quantity
- N/A
- Recall started
- October 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0044-2025
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Class II Ongoing
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98
Reason: Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Lots, distribution and details
- Lots / codes
- Lot # NB240316, Exp 12/31/25
- Distribution
- USA nationwide.
- Quantity
- 1,875 boxes (cipla and exlan)
- Recall started
- October 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0043-2025
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Class II Ongoing
Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC 29716, USA, Ph: 704-629-8203, www.trinitygold.com, Made in India, UPC 802992001009
Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Lots, distribution and details
- Lots / codes
- Lot #: IN-030, Exp. Date: NOV 2027
- Distribution
- Nationwide within the United States; additionally Canada, England, and Australia.
- Quantity
- 150
- Recall started
- November 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0042-2025
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Class II Ongoing
Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 619…
Reason: Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Lots, distribution and details
- Product
- Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40 count bottles), d) NDC 61919-0621-60 (60 count bottles), e) NDC 61919-0621-90 (90 count bottles), f) NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles), g) NDC 61919-0621-72 (120 count bottles).
- Lots / codes
- Lot #s: a) 02FE2414, Exp 11/30/26. b) 18JU2407, Exp 11/30/26; 27JY2316, Exp 02/28/27; 13SE2317, 13OC2312, 23AU2307, Exp 03/31/27. c) 25SE2308, Exp 03/31/27. d) 29MA2313, 23MA2315, Exp 12/31/26; 25MY2304, Exp 01/31/27; 26JU2313, 27JY2314, Exp 02/28/27. e) 27SE2322, 30OC2304, 12OC2301, Exp 03/31/27. f) 11SE2322, 02FE2419, 23JA2405, 10JA2426, 17MY2416, 05DE2312, 24OC2321, 05FE2433, 20MA2418, 29NO2317, Exp 11/30/26. g) 31MA2308, Exp 12/31/26; 25SE2305, Exp 03/31/27.
- Distribution
- Nationwide in the US
- Quantity
- 1410 bottles
- Recall started
- August 9, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0041-2025
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Class I Terminated
Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317
Reason: Presence of Particulate Matter: Presence of glass particulates.
Lots, distribution and details
- Lots / codes
- Lot #SP2400058, Exp 12/31/2024
- Distribution
- Nationwide in the USA
- Quantity
- 4773 vials
- Recall started
- September 30, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0040-2025
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Class II Ongoing
Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation,…
Reason: Labeling: Missing Label
Lots, distribution and details
- Product
- Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC: 36000-364-01
- Lots / codes
- Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025
- Distribution
- Nationwide within the USA
- Quantity
- 60,594 units
- Recall started
- October 30, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0039-2025
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Class II Ongoing
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.
Reason: Crystallization
Lots, distribution and details
- Lots / codes
- Lots T401151, Exp, 06/30/2026; T400806, Exp 03/31/2026
- Distribution
- USA Nationwide
- Quantity
- 6048 pumps
- Recall started
- October 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0038-2025
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Class II Ongoing
Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.
Reason: Failed Impurities/Degradation Specification
Lots, distribution and details
- Product
- Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.
- Lots / codes
- Lot# FG13996, Exp 09/30/2025
- Distribution
- Nationwide in the USA
- Quantity
- 532 100-count bottles
- Recall started
- October 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0037-2025
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Class II Ongoing
Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.
Reason: Failed Impurities/Degradation Specification
Lots, distribution and details
- Product
- Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.
- Lots / codes
- Lot# FG14062, Exp 10/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 2,040 100-count bottles
- Recall started
- October 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0036-2025
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Class II Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
Reason: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Lots, distribution and details
- Lots / codes
- Lot #: 083L051, Exp. Date: 11/2025
- Distribution
- Distributed to one Us Distributor in NJ.
- Quantity
- 155,232 bottles
- Recall started
- October 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0035-2025
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Class III Ongoing
Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code#…
Reason: Crystallization: Lack of uniformity – a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Lots, distribution and details
- Product
- Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018
- Lots / codes
- Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025
- Distribution
- Product was distributed to two accounts that may have distributed the product further to the Retail Level.
- Quantity
- 105,048 bottles
- Recall started
- September 25, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0034-2025
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Class III Ongoing
Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code #…
Reason: Crystallization: Lack of uniformity – a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Lots, distribution and details
- Product
- Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155
- Lots / codes
- Lot# 0104V, Exp 07/2025; 0106V, Exp 09/2024
- Distribution
- Product was distributed to two accounts that may have distributed the product further to the Retail Level.
- Quantity
- 72,648 bottles
- Recall started
- September 25, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0033-2025
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Class II Terminated
Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceut…
Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Lots, distribution and details
- Product
- Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad – 382 210, INDIA.
- Lots / codes
- a) Lot #: Expiry Date: M2303264 01/2026 b) Lot #: Expiry Date: M2306979 04/2026
- Distribution
- Nationwide in the USA and PR
- Quantity
- N/A
- Recall started
- October 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0032-2025
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Class II Terminated
Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceut…
Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Lots, distribution and details
- Product
- Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad – 382 210, INDIA.
- Lots / codes
- a) Lot #: Expiry Date: M2204481 02/2025 M2212389 08/2025 M2214271 09/2025 M2215970 10/2025 M2216458 10/2025 b) Lot #: Expiry Date: M2212869 08/2025 M2216362 09/2025 M2215969 10/2025
- Distribution
- Nationwide in the USA and PR
- Quantity
- N/A
- Recall started
- October 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0031-2025
-
Class II Terminated
Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuti…
Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Lots, distribution and details
- Product
- Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad – 382 210, INDIA.
- Lots / codes
- a) Lot #: Expiry Date: M2118190 11/2024 M2201091 11/2024 M2206241 11/2024 M2206451 04/2025 M2208674 06/2025 M2213850 08/2025 M2215221 09/2025 M2216236 11/2025 M2217098 11/2025 M2300664 11/2025 b) Lot #: Expiry Date: M2210808 06/2025 M2212212 08/2025 M2214435 09/2025 M2217097 11/2025 M2301921 01/2026
- Distribution
- Nationwide in the USA and PR
- Quantity
- N/A
- Recall started
- October 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0030-2025
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Class II Terminated
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
Reason: Superpotent Drug: Stability failure for assay at 6 months test time-point.
Lots, distribution and details
- Lots / codes
- Lot # 24A27724, Exp 01/31/2027
- Distribution
- Product was shipped to two private label customers ( OH & MO) as a final packaged product.
- Quantity
- 4,901 cases/24 count each case
- Recall started
- October 21, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0029-2025
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Class II Ongoing
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Lots, distribution and details
- Lots / codes
- Lot# T2201443, Exp 03/2025; T2300664, Exp 12/2025.
- Distribution
- USA Nationwide.
- Quantity
- 10584 bottles
- Recall started
- October 9, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0028-2025
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Class II Ongoing
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.
Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Lots, distribution and details
- Lots / codes
- Lot# T2200698, Exp 01/2025; T2201444, Exp 03/2025; T2202827, Exp 06/2025; T2300531, Exp 12/2025; T2301696, Exp 02/2026; T2304726, Exp 08/2026; T2400480, Exp 11/2026.
- Distribution
- USA Nationwide.
- Quantity
- 35880 bottles
- Recall started
- October 9, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0027-2025
-
Class II Ongoing
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.
Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Lots, distribution and details
- Lots / codes
- Lot# T2200120, T2200121, T2200119, T2200116, T2200118, T2200117, Exp 11/2024; T2200695, T2200694, T2200696, T2200697, Exp 01/2025; T2201426, T2201428, T2201432, T2201427, T2201430, T2201429, T2201431, Exp 03/2025; T2202743, T2202742, T2202741, & T2202740, Exp 06/2025; T2203081, T2203079, T2203080, T2203082, T2203083 & T2203084, Exp 07/2025; T2300770, T2300771, T2300769, T2300766, T2300767 & T2300768, Exp 12/2025 Lots T2301663, T2301665, T2301662, T2301664, T2301667, T2301661, T2301666, T2301660, T2301658 & T2301659, Exp Date 02/2026 Lots T2304704, T2304703, T2304705, T2304706, Exp Date 08/2026 Lots T2400468, T2400469, T2400473 & T2400474 Exp Date 11/2026
- Distribution
- USA Nationwide.
- Quantity
- 285126 bottles
- Recall started
- October 9, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0026-2025
-
Class II Ongoing
OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #ODS230001A, ODS230002A, Exp. 10/2025; ODS230003A, Exp. 11/2025.
- Distribution
- Nationwide in the US
- Quantity
- 10845 bottles
- Recall started
- October 15, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0025-2025
-
Class II Ongoing
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
Reason: Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Lots, distribution and details
- Lots / codes
- All Lots
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- October 8, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0024-2025
-
Class II Terminated
Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56
Reason: cGMP violations
Lots, distribution and details
- Lots / codes
- Lot # C274-000037436, exp. date 30-Oct-24 C274-000038893, exp. date 7-Jan-25
- Distribution
- Product was distributed to 125 direct accounts nationwide.
- Quantity
- 1008 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-0023-2025
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.