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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

4401–4425 of 17762

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-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-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-0490-2022·2022-02-09
DILOTAB II Sinus Cold Relief Drug Recalled for Manufacturing Deviations
Ultra Seal Corporation is recalling DILOTAB II Sinus and Cold Relief tablets nationwide due to cGMP (current good manufacturing practice) deviations. Approximately 2.7 million packets containing acetaminophen 325 mg and phenylephrine HCl 5 mg are affected.
Product
DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-052-03
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-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-0509-2022·2022-02-09
Drug Recall: FEM-PRIN Menstrual Relief Tablets for cGMP Deviations
Ultra Seal Corporation is recalling FEM-PRIN Menstrual Relief tablets (223,090 packets) distributed nationwide due to cGMP deviations. The recall was voluntary and initiated on January 24, 2022.
Product
FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
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-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-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-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-0469-2022·2022-02-09
Extra Strength Pain Reliever Acetaminophen Recalled for cGMP Deviations
Ultra Seal Corporation is recalling Extra Strength Pain Reliever (acetaminophen 500 mg) 2 tablet packets nationwide due to cGMP deviations. The recall affects Lot #AK9602 with expiration date 05/2022.
Product
Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0464-2022·2022-02-09
Nasal & Sinus Decongestant Recalled for cGMP Deviations
Ultra Seal Corporation is voluntarily recalling Nasal & Sinus Decongestant packets containing phenylephrine HCl 5mg due to current good manufacturing practice (cGMP) deviations. The recall affects 3,508,200 packets distributed nationwide.
Product
Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040
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-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-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-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-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
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-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
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-0416-2022·2022-02-02
Edge Pharma Phenylephrine HCl IV Injection Sterility Assurance Recall
Edge Pharma is recalling Phenylephrine HCl 1mg/10mL single-use syringes for IV injection due to lack of assurance of sterility. The recall affects 6,535 vials distributed nationwide.
Product
Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0398-2022·2022-02-02
Cefuroxime Sterile Ophthalmic Injection Recalled Due to Sterility Concerns
Edge Pharma is recalling Cefuroxime sterile ophthalmic solution for injection because the company cannot assure the product meets sterility requirements. The recall affects approximately 1,720 syringes distributed nationwide.
Product
Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446 NDC 05446-1003-01
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

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4401–4425 of 17762