Advertisement



Drug Recalls

Last updated

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.

1,094 recalls

  • Class II Completed

    Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259…

    Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

    SUN PHARMACEUTICAL INDUSTRIES INC · Niacin

    Lots, distribution and details
    Product
    Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-613-81.
    Lots / codes
    Lot #: DNE0788A Exp. 07/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    6552 bottles
    Recall started
    January 18, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0269-2024
  • Class II Completed

    Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industri…

    Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

    SUN PHARMACEUTICAL INDUSTRIES INC · Mesalamine

    Lots, distribution and details
    Product
    Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 63304-175-13.
    Lots / codes
    Lot #s: DNE0875A Exp. 01/31/2025; DNE0876A, DNE0877A, DNE1080A, DNE1081A Exp. 02/28/2025; DNE1147A, DNE1148A Exp. 03/31/2025.
    Distribution
    Nationwide in the USA
    Quantity
    10,690 bottles
    Recall started
    January 18, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0268-2024
  • Class II Completed

    Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dad…

    Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

    SUN PHARMACEUTICAL INDUSTRIES INC · Lurasidone Hydrochloride

    Lots, distribution and details
    Product
    Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-579-83.
    Lots / codes
    Lot #s: DNE0621A Exp. 11/30/2024, DNE0815A Exp. 12/31/2024
    Distribution
    Nationwide in the USA
    Quantity
    9,408 bottles
    Recall started
    January 18, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0267-2024
  • Class II Completed

    Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadr…

    Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

    SUN PHARMACEUTICAL INDUSTRIES INC · Lurasidone Hydrochloride

    Lots, distribution and details
    Product
    Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-639-83.
    Lots / codes
    Lot #: DNE0620A Exp. 05/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    11,400 bottles
    Recall started
    January 18, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0266-2024
  • Class II Completed

    Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, (U…

    Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

    SUN PHARMACEUTICAL INDUSTRIES INC · Febuxostat

    Lots, distribution and details
    Product
    Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-722-83.
    Lots / codes
    Lot #s: DNE0867A Exp. 06/30/2025, DNE0894B Exp. 07/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    19,992 bottles
    Recall started
    January 18, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0265-2024
  • Class II Completed

    Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191 (U.T…

    Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

    SUN PHARMACEUTICAL INDUSTRIES INC · Febuxostat

    Lots, distribution and details
    Product
    Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 47335-721-83.
    Lots / codes
    Lot #s: DNE0866B Exp. 06/30/2025, DNE1045A, DNE1046B Exp. 08/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    55,272 bottles
    Recall started
    January 18, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0264-2024
  • Class II Completed

    Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U…

    Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

    SUN PHARMACEUTICAL INDUSTRIES INC · Cinacalcet

    Lots, distribution and details
    Product
    Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), India, NDC 47335-380-83.
    Lots / codes
    Lot #: DNE0702A, Exp. 06/30/2026
    Distribution
    Nationwide in the USA
    Quantity
    1,728 bottles
    Recall started
    January 18, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0263-2024
  • Class II Terminated

    Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 203 New Edition Court…

    Reason: Lack of Sterility Assurance: Aseptic process simulation failure.

    BE PHARMACEUTICALS AG · Fosaprepitant

    Lots, distribution and details
    Product
    Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511, Made in India, NDC 71839-104-01.
    Lots / codes
    lot #13D012AA, Exp: 08/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    22,176 Vials
    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-0262-2024
  • Class I Ongoing

    Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18

    Reason: Presence of particulate matter: glass

    PFIZER · Bleomycin

    Lots, distribution and details
    Lots / codes
    Lot #: BL12206A, Exp date 06/30/2024
    Distribution
    Nationwide in the USA, Netherlands and Libya
    Quantity
    3,546 vials
    Recall started
    December 21, 2023 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0261-2024
  • Class II Terminated

    Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru – 562106, India. Distributed by:Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-752-16

    Reason: Failed Dissolution Specifications

    Strides Pharma Inc. · Methoxsalen

    Lots, distribution and details
    Lots / codes
    Lot #: 7253092B, Exp Date 09/30/2025
    Distribution
    Nationwide in the USA
    Quantity
    396 50-count bottles
    Recall started
    December 29, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0260-2024
  • Class III Ongoing

    Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11

    Reason: Superpotent drug: Assay results were slightly above specification at the time zero point.

    Amerisource Health Services LLC · Benzonatate

    Lots, distribution and details
    Product
    Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11
    Lots / codes
    Lot # 1014208, Exp Mar/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    6,344 cartons
    Recall started
    December 26, 2023 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0257-2024
  • Class II Terminated

    Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deodorant Spray, Topical spray can, Net WT 6.0 OZ (170g), Distributed by Procter & Gamble, Cincinnati, OH 45202. NDC: 37000-199-60, UPC 0 12044 001…

    Reason: CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene

    The Procter & Gamble Company

    Lots, distribution and details
    Product
    Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deodorant Spray, Topical spray can, Net WT 6.0 OZ (170g), Distributed by Procter & Gamble, Cincinnati, OH 45202. NDC: 37000-199-60, UPC 0 12044 00191 2
    Lots / codes
    All lots with expiry through September 2023
    Distribution
    Nationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands, American Samoa, Bhutan, Timor-Leste, Maldives, Fiji, US Virgin Islands, Trinidad, Peru, Saint Marteen, Bahamas, Costa Rica, Guatemala, Honduras, Panama, Belize, Santa Lucia, Aruba, Dominican Republic, Guyana
    Quantity
    unknown
    Recall started
    November 23, 2021 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0250-2024
  • Class I Terminated

    Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deodorant Spray, Topical spray can, Net WT 6.0 OZ (170g), Distributed by Procter & Gamble, Cincinnati, OH 45202. NDC: 37000-199-60, UPC 0 12044 001…

    Reason: Chemical contamination: presence of benzene

    The Procter & Gamble Company

    Lots, distribution and details
    Product
    Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deodorant Spray, Topical spray can, Net WT 6.0 OZ (170g), Distributed by Procter & Gamble, Cincinnati, OH 45202. NDC: 37000-199-60, UPC 0 12044 00191 2
    Lots / codes
    Lot #: 11661458SM, 11681458SB, Exp 5/31/23; 12621458SV, 12631458SB, Exp 08/31/23
    Distribution
    Nationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands, American Samoa, Bhutan, Timor-Leste, Maldives, Fiji, US Virgin Islands, Trinidad, Peru, Saint Marteen, Bahamas, Costa Rica, Guatemala, Honduras, Panama, Belize, Santa Lucia, Aruba, Dominican Republic, Guyana
    Quantity
    unknown
    Recall started
    November 23, 2021 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0238-2024
  • Class II Ongoing

    Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-626-90

    Reason: Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.

    Ascend Laboratories, LLC · Ibuprofen and Famotidine

    Lots, distribution and details
    Lots / codes
    23140190, Exp. Date 12/31/2024
    Distribution
    Nationwide
    Quantity
    3,288 bottles
    Recall started
    December 29, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0237-2024
  • Class II Ongoing

    Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Par Pharmaceutical, Ch…

    Reason: Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.

    Par Sterile Products LLC · Vasopressin

    Lots, distribution and details
    Product
    Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-237-10
    Lots / codes
    Lot # 66702; Exp. 02/2025
    Distribution
    Nationwide USA
    Quantity
    1721 cartons
    Recall started
    January 11, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0232-2024
  • Class II Ongoing

    CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Flavor 10 fl. oz, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.

    Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS – Presence of Acetobacter nitrogenifigens bacteria.

    Pharma Nobis LLC

    Lots, distribution and details
    Lots / codes
    Lot A80763; Exp. 11/2025
    Distribution
    Nationwide.
    Quantity
    13,344 bottles
    Recall started
    December 21, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0229-2024
  • Class II Ongoing

    Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Free Low Sodium, Grape flavor 10 fl. oz, Distributed by: Walgreen Co, 200 Wilmot Rd, Deerfield, IL 60015, NDC 0363-0427-98.

    Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS – Presence of Acetobacter nitrogenifigens bacteria.

    Pharma Nobis LLC · Magnesium Chloride

    Lots, distribution and details
    Lots / codes
    Lot A80623; Exp. 11/30/2025
    Distribution
    Nationwide.
    Quantity
    49,716 Bottles
    Recall started
    December 21, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0228-2024
  • Class II Ongoing

    Good Neighbor Pharmacy, DYE FREE, SUGAR FREE Magnesium Citrate Saline Laxative, Oral Solution, Cherry Flavor 10 fl. oz, Distributed by AmerisourceBergen, 1 West First Ave, Conshochoken, PA 19428, NDC 46122-741-38

    Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS – Presence of Acetobacter nitrogenifigens bacteria.

    Pharma Nobis LLC · Magnesium Chloride

    Lots, distribution and details
    Lots / codes
    Lots A80673, A80742; Exp 10/31/2025
    Distribution
    Nationwide.
    Quantity
    24,684 Bottles
    Recall started
    December 21, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0227-2024
  • Class II Ongoing

    Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-60…

    Reason: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

    Seaway Pharma Inc. · Oxymetazoline Hydrochloride

    Lots, distribution and details
    Product
    Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-608-01, UPC 6-35515-98846-0
    Lots / codes
    Lot # SE23035, Exp 05/31/2026
    Distribution
    MI, PA
    Quantity
    8,160 bottles
    Recall started
    December 28, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0217-2024
  • Class II Ongoing

    Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, MI 48375, NDC# 63868-…

    Reason: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

    Seaway Pharma Inc. · Oxymetazoline Hydrochloride

    Lots, distribution and details
    Product
    Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, MI 48375, NDC# 63868-676-01, UPC 6-35515-98847-7.
    Lots / codes
    Lot # SE23034, Exp 05/31/2026
    Distribution
    MI, PA
    Quantity
    7,992 bottles
    Recall started
    December 28, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0216-2024
  • Class II Ongoing

    Premier Value Tussin Cough DM, Dextromethorphan HBr…Cough Suppressant, Guaifenesin…Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA…

    Reason: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

    Seaway Pharma Inc.

    Lots, distribution and details
    Product
    Premier Value Tussin Cough DM, Dextromethorphan HBr…Cough Suppressant, Guaifenesin…Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA 19087, UPC 8-40986-03789-4.
    Lots / codes
    Lot # SD23033, Exp 04/30/2025
    Distribution
    MI, PA
    Quantity
    4,176 bottles
    Recall started
    December 28, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0215-2024
  • Class II Ongoing

    Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 63868-607-01, UPC 6-3551…

    Reason: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

    Seaway Pharma Inc. · Oxymetazoline Hydrochloride

    Lots, distribution and details
    Product
    Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 63868-607-01, UPC 6-35515-98843-9, b) Premier Value, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne, PA 19087 UPC 8-40986-03509-8.
    Lots / codes
    Lot # SD23032, Exp 04/30/2026
    Distribution
    MI, PA
    Quantity
    7,992 bottles
    Recall started
    December 28, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0214-2024
  • Class I Ongoing

    Sure Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5518-06

    Reason: Chemical contamination: Presence of benzene

    TCP HRB ACQUISITON LLC

    Lots, distribution and details
    Lots / codes
    All lots, expiry on or before August 2023
    Distribution
    Nationwide in the US and Canada
    Quantity
    5.4 million
    Recall started
    February 16, 2022 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0209-2024
  • Class I Ongoing

    Sure Unscented Anti-perspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5517-06

    Reason: Chemical contamination: Presence of benzene

    TCP HRB ACQUISITON LLC

    Lots, distribution and details
    Lots / codes
    All lots, expiry on or before August 2023
    Distribution
    Nationwide in the US and Canada
    Quantity
    0.5 million
    Recall started
    February 16, 2022 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0208-2024
  • Class I Ongoing

    Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packaged in a) 4 oz. (113g) aerosol cans (UPC 00827755070085, NDC 41595-7103-1) and b) 6 oz. (170g) aerosol cans (UPC 00827755070108, NDC 41595-7103-…

    Reason: Chemical contamination: Presence of benzene

    TCP HRB ACQUISITON LLC

    Lots, distribution and details
    Product
    Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packaged in a) 4 oz. (113g) aerosol cans (UPC 00827755070085, NDC 41595-7103-1) and b) 6 oz. (170g) aerosol cans (UPC 00827755070108, NDC 41595-7103-2), Distributed by Idelle Labs, Ltd. El Paso, TX 79912 USA
    Lots / codes
    All lots, expiry on or before August 2023
    Distribution
    Nationwide in the US and Canada
    Quantity
    a) 0.4 million cans, b) 3.4 million cans
    Recall started
    February 16, 2022 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0207-2024

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.

Advertisement