The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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4501–4525 of 18005

  • ModerateFDA (Drugs)·D-0513-2022·2022-02-09

    Sinus Decongestant Nasal Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling 448,300 packets of SINUS DECONGESTANT (phenylephrine HCl 5mg) tablets due to current Good Manufacturing Practice (cGMP) deviations. The recall affects nationwide distribution.

    Product
    SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0505-2022·2022-02-09

    CVS Health Natural Sleep Aid Chewable Tablets Recalled for Manufacturing Deviations

    CVS Health Natural Sleep Aid Chewable Tablets (melatonin 1.5mg) in cherry flavor are being recalled nationwide due to cGMP manufacturing deviations. The manufacturer, Ultra Seal Corporation, initiated the voluntary recall of 241,560 bottles.

    Product
    CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0477-2022·2022-02-09

    Cetafen acetaminophen tablets recalled for manufacturing deviations

    Ultra Seal Corporation is recalling Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets in 2-count packets due to current good manufacturing practice (cGMP) deviations. The recall affects 915,770 packets distributed nationwide.

    Product
    Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0516-2022·2022-02-09

    REMfresh Advanced Ion-Powered Melatonin Caplets Recalled for cGMP Deviations

    Ultra Seal Corporation is voluntarily recalling REMfresh Advanced Ion-Powered Melatonin 2 mg Caplets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 12-count and 36-count blister packages distributed across the United States.

    Product
    REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0489-2022·2022-02-09

    SINU-PHEN PLUS Sinus Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling SINU-PHEN PLUS sinus pain and congestion tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects approximately 122,400 packets distributed across the United States.

    Product
    SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0468-2022·2022-02-09

    Drug Recall: CHLORESIN Cold and Cough Medication Due to Manufacturing Violations

    Ultra Seal Corporation is voluntarily recalling CHLORESIN, a combination cold and cough medication, due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 225,350 packets distributed nationwide.

    Product
    CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0508-2022·2022-02-09

    Nutralox Mint Antacid Chewable Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling 1,486,050 packets of Nutralox Mint Antacid chewable tablets (calcium carbonate 420mg, 2-count packets) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0485-2022·2022-02-09

    Pain Away Pain Reliever/Fever Reducer Drug Recall for cGMP Deviations

    Ultra Seal Corporation is recalling 1,186,000 packets of Pain Away Pain Reliever/Fever Reducer nationwide due to manufacturing practice deviations. The recall was initiated by the firm on a voluntary basis.

    Product
    Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg, caffeine 32.4 mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0472-2022·2022-02-09

    DBI 357 Super Magnum Caffeine Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling DBI 357 Super Magnum Quick Energy Stimulant caffeine tablets distributed nationwide due to current good manufacturing practice (cGMP) deviations. The recall includes 36-count, 100-count, and 500-count bottles, as well as 3-count packets.

    Product
    DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, packaged in a) 36-count bottles, b) 100-count bottles, c) 500-count bottles, and d) 3-count packets, Marketed by: DBI Distribution A Division of King Richard Promotions, Inc. P.O. Box 78546, Indianapolis, IN 46
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0503-2022·2022-02-09

    PEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is voluntarily recalling PEPTIME Energy (caffeine 350mg) tablets due to cGMP (current good manufacturing practice) deviations. The recall affects 113,040 packets and 7,132 bottles distributed nationwide.

    Product
    PEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0476-2022·2022-02-09

    Drug Recall: Back Pain-Off Tablets Over cGMP Violations

    Ultra Seal Corporation is voluntarily recalling Back Pain-Off tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects approximately 1.96 million 2-count packets distributed across the United States.

    Product
    Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47682-073-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0475-2022·2022-02-09

    Drug recall: MidNite Sleep Health melatonin tablets, cGMP deviations

    Ultra Seal Corporation is voluntarily recalling MidNite Sleep Health melatonin tablets nationwide due to current good manufacturing practice (cGMP) deviations. Approximately 2.2 million bottles are affected.

    Product
    MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare, Inc. Morgantown, WV 26505 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0501-2022·2022-02-09

    PEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling PEPTIME Energy 250mg caffeine tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 100-count bottles distributed in the United States.

    Product
    PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0465-2022·2022-02-09

    Cold Tablet with Acetaminophen Recalled for cGMP Deviations

    Ultra Seal Corporation is voluntarily recalling Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant packets due to cGMP (current Good Manufacturing Practice) deviations. Approximately 313,000 packets of Lot #K9824 (Exp. Date 09/2022) distributed nationwide are affected.

    Product
    Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0487-2022·2022-02-09

    Cold Terminator decongestant recalled for cGMP deviations

    Ultra Seal Corporation is voluntarily recalling Cold Terminator decongestant/cold relief tablets due to manufacturing compliance deviations. The recall affects 226,400 packets distributed nationwide.

    Product
    COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus Medical Products, Carlsbad, CA 92011, NDC 69103-2556
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0479-2022·2022-02-09

    Lite Remfresh Melatonin Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling Lite Remfresh Advanced Ion-Powered Melatonin 0.5mg tablets nationwide due to cGMP (current good manufacturing practices) deviations. The recall affects 25,776 blisters in lots 19E058A and 19E058B with an expiration date of May 2022.

    Product
    Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0491-2022·2022-02-09

    Extra Strength Un-Aspirin Acetaminophen Packets Recalled for cGMP Deviations

    Ultra Seal Corporation has voluntarily recalled 1,694,200 packets of Extra Strength Un-Aspirin (acetaminophen 500 mg) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-041-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0522-2022·2022-02-09

    Prescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals

    Teva Pharmaceuticals USA is recalling Mimvey (estradiol and norethindrone acetate) tablets nationwide due to mislabeling. The recall affects 6,430 cartons distributed throughout the USA.

    Product
    MIMVEY — MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0521-2022·2022-02-09

    Mimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall

    Teva Pharmaceuticals USA is recalling Mimvey (estradiol and norethindrone acetate) tablets nationwide due to mislabeling on certain cartons. The recall affects 218,174 cartons distributed in the United States.

    Product
    MIMVEY — MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0408-2022·2022-02-02

    Mitomycin-C Sterile Ophthalmic Solution Lacks Sterility Assurance

    Edge Pharma is recalling Mitomycin-C Sterile Ophthalmic Solution because the manufacturer cannot assure that the product is sterile. The recall affects 163 syringes distributed nationwide.

    Product
    Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1009-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0415-2022·2022-02-02

    Edge Pharma Phenylephrine HCl Syringes Recalled for Sterility Assurance

    Edge Pharma, LLC is recalling Phenylephrine HCl 0.5 mg/5mL single-use syringes for intravenous injection nationwide due to lack of assurance of sterility. The affected product was distributed between September 2021 and January 2022.

    Product
    Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0407-2022·2022-02-02

    Mitomycin-C Injectable Syringes Recalled for Sterility Assurance Failure

    Edge Pharma is recalling Mitomycin-C 40 mg/40 mL single-dose syringes (NDC 05446-1416-01) nationwide due to lack of assurance of sterility. Approximately 860 syringes are affected.

    Product
    Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0413-2022·2022-02-02

    Phenol Injection Solution Recall Due to Lack of Sterility Assurance

    Edge Pharma, LLC is recalling Phenol Sterile Solution for Injection (6%, 5 mL vials) nationwide due to lack of assurance of sterility. The recall affects 309 vials distributed under specific lot codes.

    Product
    Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1476-05, packaged in vials.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0410-2022·2022-02-02

    Moxifloxacin Ophthalmic Injection Syringes Recalled for Sterility Risk

    Edge Pharma is recalling Moxifloxacin sterile ophthalmic injection syringes nationwide due to lack of assurance of sterility. The 860 affected syringes were distributed across two lots.

    Product
    Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LL, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1050-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0418-2022·2022-02-02

    Phenylephrine Injection Recall Due to Sterility Assurance Concerns

    Edge Pharma is recalling phenylephrine injection (20 mg/250 mL) because the manufacturer cannot assure the product maintains sterility. The recall affects 3,930 bags distributed nationwide.

    Product
    PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT NDC 05446-1667-01
    Category
    Drug
    Distribution
    Distributed nationwide