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

4751–4775 of 5062

SevereFDA (Drugs)·D-0014-2022·2021-10-27
Coppertone SPORT Sunscreen Spray recalled for benzene contamination
Beiersdorf Inc. is recalling Coppertone SPORT Sunscreen Spray 50 (1.6 oz cans) nationwide due to the presence of benzene, a known carcinogen. Affected lot TN00BU3 expires 05/31/2024.
Product
Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 41100 00506 9
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0013-2022·2021-10-27
Coppertone SPORT MINERAL 50 Sunscreen Spray Recalled for Benzene Contamination
Beiersdorf Inc. is recalling Coppertone SPORT MINERAL 50 Sunscreen Spray due to the presence of benzene, a chemical contaminant. The recall affects 142,236 cans distributed nationwide.
Product
Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02870 1
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0023-2022·2021-10-27
AirDuo Digihaler 55/14 Inhalation Powder Recalled for Subpotent Dose
Teva Pharmaceuticals is recalling AirDuo Digihaler 55/14 inhalation powder due to subpotent emitted dose of salmeterol. Approximately 1,978 inhalers distributed nationwide may deliver less medication than labeled.
Product
AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0012-2022·2021-10-27
Coppertone Pure & Simple Baby Sunscreen Spray Recalled for Benzene Contamination
Beiersdorf Inc. is recalling Coppertone Pure & Simple Baby 50 Sunscreen Spray nationwide due to the presence of benzene, a chemical contaminant. Consumers should stop using affected products immediately.
Product
Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0011-2022·2021-10-27
Coppertone Pure & Simple Kids 50 Sunscreen Spray Recalled for Benzene Contamination
Beiersdorf Inc. is recalling Coppertone Pure & Simple kids 50 Sunscreen Spray due to the presence of benzene, a chemical contaminant. The affected product was distributed nationwide.
Product
Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0020-2022·2021-10-27
GlipiZIDE Extended-Release Tablets 2.5 mg Nationwide Recall
American Health Packaging is recalling GlipiZIDE Extended-Release Tablets 2.5 mg (Lot #194141) nationwide because dissolution test results exceeded specification, which may affect the drug's effectiveness.
Product
GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0016-2022·2021-10-27
Coppertone Pure & Simple Kids 50 Sunscreen Spray Recalled for cGMP Deviations
Beiersdorf Inc. is voluntarily recalling Coppertone Pure & Simple kids 50 Sunscreen Spray due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 70,320 cans distributed nationwide.
Product
Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0027-2022·2021-10-27
Lupin Imipramine Pamoate Capsules Recalled for Failed Dissolution Test
Lupin Pharmaceuticals is recalling approximately 1,902 bottles of Imipramine Pamoate Capsules 125 mg due to out-of-specification results in dissolution testing at the 9-month stability checkpoint.
Product
IMIPRAMINE PAMOATE — IMIPRAMINE PAMOATE (IMIPRAMINE PAMOATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0025-2022·2021-10-27
AirDuo Digihaler 232/14 Inhalation Powder Recall for Subpotent Salmeterol
Teva Pharmaceuticals is recalling approximately 5,500 units of AirDuo Digihaler 232/14 inhalation powder distributed nationwide because some inhalers contain less salmeterol than the labeled dose.
Product
AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0017-2022·2021-10-27
Coppertone Pure & Simple Baby 50 Sunscreen Spray Recalled for cGMP Deviations
Beiersdorf Inc. is recalling 14,748 cans of Coppertone Pure & Simple baby 50 Sunscreen Spray due to cGMP (current Good Manufacturing Practice) deviations. The product was distributed nationwide.
Product
Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0015-2022·2021-10-27
Coppertone Pure & Simple 50 Sunscreen Spray Recall for cGMP Deviations
Beiersdorf Inc. is recalling Coppertone Pure & Simple 50 Sunscreen Spray due to manufacturing practice deviations. Approximately 36,660 cans were distributed nationwide.
Product
Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0024-2022·2021-10-27
AirDuo Digihaler inhalation powder subpotent drug recall
Teva Pharmaceuticals is recalling AirDuo Digihaler 113/14 inhalation powder because some batches do not deliver the labeled amount of salmeterol, a critical active ingredient for asthma and COPD control.
Product
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0022-2022·2021-10-27
AirDuo Digihaler 232/14 Inhalation Powder Subpotent Recall
Teva Pharmaceuticals is recalling AirDuo Digihaler 232/14 inhalation powder because some units do not deliver the correct amount of salmeterol as labeled.
Product
AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0018-2022·2021-10-27
Cleaning Solutions Foaming Hand Sanitizer Recalled for Skin Irritation Risk
Sanitor Corporation is recalling Cleaning Solutions Foaming Hand Sanitizer (Benzalkonium chloride 0.1%) due to contamination from Current Good Manufacturing Practice (CGMP) deviations. Use may cause skin or soft tissue infection and irritation.
Product
Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC, 7001 W Arby Ave Suite 100, Las Vegas, NV 89113, UPC#: 8 60001 93396 3
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0021-2022·2021-10-27
AirDuo Digihaler 113/14 Inhalation Powder Subpotent Drug Recall
Teva Pharmaceuticals is recalling AirDuo Digihaler 113/14 inhalation powder because some units contain less salmeterol than the labeled dose. The affected sample batch was distributed nationwide.
Product
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC , Frazer, PA 19355, Manufactured in Ireland, NDC 59310-520-08
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0019-2022·2021-10-27
Rocuronium Bromide Injection Lacks Paralyzing Agent Warning
Piramal Critical Care is recalling Rocuronium Bromide Injection because the finished product vial lacks the required "WARNING: PARALYZING AGENT" statement on the flip cap. The missing warning could lead to unsafe use of this prescription neuromuscular-blocking drug.
Product
Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured by: Sanovel Ilac, San. Ve Tic. A.S. Istanbul, Turkey, NDC 66794-0228-41
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0026-2022·2021-10-27
Omeprazole Magnesium Acid Reducer Capsules Recalled for Staple Contamination
Dr. Reddy's Laboratories is recalling Acid Reducer (Omeprazole Magnesium) 20 mg capsules nationwide because staples have been found co-mingled with capsules in bottles.
Product
ACID REDUCER — ACID REDUCER (OMEPRAZOLE MAGNESIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0009-2022·2021-10-20
Glucagon Emergency Kit Recall: Subpotent Drug in Vials
Eli Lilly is recalling Glucagon Emergency Kits (Lot #D239382D, expiration April 2022) because some vials contain liquid instead of powder and do not deliver the full expected drug effect when administered.
Product
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285; Glucagon, NDC: 0002-8031-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0007-2022·2021-10-20
Potassium Chloride Injection Recall Due to Sterility Assurance Lack
SSM Health Care St. Louis is recalling 385 bags of Potassium Chloride 40 mEq in 0.9% Sodium Chloride injection due to lack of assurance of sterility. The affected lot was distributed in Missouri.
Product
Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bowles, Fenton, MO. NDC 60652-6429-1
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0006-2022·2021-10-20
Potassium Chloride Extended-Release Tablets Recalled for Failed Dissolution
Strides Pharma Inc. is recalling Potassium Chloride Extended-Release Tablets, USP 10 mEq because the tablets fail to meet dissolution specifications, which may affect drug effectiveness.
Product
POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0004-2022·2021-10-13
Betaxolol Ophthalmic Solution Recalled for Sterility Failure
Akorn, Inc. is recalling Betaxolol Ophthalmic Solution, USP 0.5% due to confirmed sterility failure detected during stability testing. The affected lot was distributed nationwide.
Product
Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0002-2022·2021-10-13
Artesunate for Injection Recalled Due to Sterility Assurance Failure
AMIVAS (US), LLC is recalling Artesunate for Injection (110 mg/vial) because an air filter failed post-integrity testing, creating a lack of sterility assurance for the product.
Product
Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-11); 4x4 pack containing 4 Single-dose vials artesunate (73607-001-01) and 4 vials ster
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0001-2022·2021-10-13
ALPHA MALE+ Male Enhancer Fruit Chew Strips Recalled for Unapproved Drug
ALPHA MALE+ Male Enhancer fruit chew strips are being recalled because they contain tadalafil and were marketed without FDA approval. Consumers should stop using the product and consult a healthcare provider if they have questions.
Product
ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0003-2022·2021-10-13
Firvanq Vancomycin Oral Solution Kits Recalled for Incorrect Diluent
Azurity Pharmaceuticals is recalling 2,751 kits of Firvanq (vancomycin hydrochloride for oral solution) distributed nationwide because an incorrect diluent component was included in the kit.
Product
FIRVANQ — FIRVANQ (VANCOMYCIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0005-2022·2021-10-13
Meclizine HCl Tablets 25 mg Recalled for Incorrect Instructions
Rising Pharmaceuticals is recalling Meclizine HCl Tablets 25 mg (Lot # CB21024, expiring 2/2023) due to incorrect labeling instructions on the packaging.
Product
Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01
Category
Drug
Distribution
0 states

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4751–4775 of 5062