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

3251–3275 of 17762

SevereFDA (Drugs)·D-0086-2023·2022-12-21
Injectable iohexol syringes recalled for mislabeled iodine strength
BayCare Integrated Service Center is recalling 250 iohexol injection syringes mislabeled as 300 mg iodine/mL but actually containing 350 mg iodine/mL. The labeling error could result in dosing mistakes.
Product
Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 30
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0080-2023·2022-12-21
FDA Recalls Sodium Bicarbonate Injection Vials for Glass Breakage Risk
Exela Pharma Sciences is recalling Sodium Bicarbonate Injection vials due to defective containers that may break and release glass fragments when pressurized during preparation. The recall affects 37,320 vials distributed nationwide.
Product
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0079-2023·2022-12-21
FDA Recalls Sodium Bicarbonate Injection for Defective Vials
Exela Pharma Sciences is recalling 489,600 vials of sodium bicarbonate injection nationwide due to defective vials that break and release glass fragments when pressurized during preparation.
Product
SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0078-2023·2022-12-21
FDA Recalls Fentanyl Citrate Injection Cassettes Due to Underfilling
OurPharma LLC is recalling 691 fentanyl citrate injection cassettes due to underfilled units. The recall affects lots distributed in Missouri with expiration dates between December 2022 and January 2023.
Product
FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0094-2023·2022-12-21
Lacosamide oral solution recalled for failed excipient specifications
Camber Pharmaceuticals is recalling specific lots of Lacosamide oral solution due to out-of-specification p-Hydroxybenzoic Acid content. The recall affects multiple lot numbers distributed nationwide.
Product
LACOSAMIDE — LACOSAMIDE (LACOSAMIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0082-2023·2022-12-21
FDA recalls Neuroquell Calendula Oil homeopathic drug for manufacturing deviations
The FDA has recalled Neuroquell Calendula Oil, a homeopathic drug, due to manufacturing practice violations. The voluntary recall affected 51 bottles distributed nationwide and in Australia.
Product
Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0081-2023·2022-12-21
Drug Neuroquell Plus Calendula Oil Recalled for Manufacturing Deviations
Neuroquell Plus, a homeopathic calendula oil drug, has been voluntarily recalled due to current good manufacturing practice (cGMP) deviations. The recall affects 461 bottles distributed nationwide and in Australia.
Product
Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0083-2023·2022-12-21
Drug Recall: ProSirona Homeopathic Calendula Oil Manufacturing Deviations
ProSirona Homeopathic Calendula Oil (Lot B-02) is being recalled because the manufacturer failed to follow Current Good Manufacturing Practice standards. The voluntary recall affects products distributed nationwide and in Australia.
Product
ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0084-2023·2022-12-21
Homeopathic Calendula Oil Recalled for Manufacturing Practice Violations
Atlantic Management Resources voluntarily recalls Menastil homeopathic calendula oil due to cGMP deviations. The 26 bottles (Lot A-01) were distributed nationwide and to Australia.
Product
Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0076-2023·2022-12-14
Intravenous Sodium Chloride Injection Recall for Potential Bag Leakage
B. Braun Medical is recalling 756 bags of 0.9% sodium chloride injection (saline) due to potential leakage that could compromise sterility. The recall affects product distributed in Florida, New Jersey, and Pennsylvania.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
3 states
HighFDA (Drugs)·D-0075-2023·2022-12-14
Injectable Sodium Chloride Solution Recalled Due to Sterility Concerns and Leakage
Fresenius Medical Care is recalling 0.9% Sodium Chloride Injection due to lack of sterility assurance from potential leakage. The nationwide recall affects injectable saline bags distributed in the United States.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0077-2023·2022-12-14
Desmopressin Acetate Tablets Recalled by Manufacturer for Subpotency
RemedyRepack Inc. is recalling Desmopressin Acetate Tablets due to subpotency. The affected tablets may not provide the intended therapeutic effect.
Product
Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816; Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC #: 70518-3493-00.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0072-2023·2022-12-07
FDA recalls prescription desmopressin acetate tablets for subpotency
Heritage Pharmaceuticals' desmopressin acetate tablets (0.2mg) have been recalled nationwide due to subpotency. The voluntary recall affects 13,805 bottles; no illnesses have been reported.
Product
DESMOPRESSIN ACETATE — DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0071-2023·2022-12-07
Daytrana transdermal methylphenidate patches recalled for adhesive defect
Noven Pharmaceuticals recalls 3,977 boxes of Daytrana methylphenidate transdermal patches nationwide due to defective adhesive properties in lot 91316. Affected patches may fail to adhere properly or deliver medication inconsistently.
Product
DAYTRANA — DAYTRANA (METHYLPHENIDATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0073-2023·2022-12-07
Allergy Relief D tablets recalled for failed dissolution specifications
Dr. Reddy's Laboratories is recalling Allergy Relief D extended-release tablets distributed nationwide by Walmart due to failed dissolution specifications. No illnesses or injuries have been reported.
Product
Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Tablets USP, packaged as (a) 20 count carton NDC 49032-273-20; (b) 30 count carton, NDC49032-273-30; Distributed by: Walmart Inc., Bentonville, AR 72716, Product
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0074-2023·2022-12-07
Acella Recalls Sodium Sulfacetamide Cleansing Pads for Subpotency
Acella Pharmaceuticals is recalling Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads because testing found the drug out of specification for potency at shelf-life expiration. 528 cartons distributed nationwide are affected.
Product
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300025, NDC 42192-113-60
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0068-2023·2022-11-30
Pantoprazole Sodium Oral Suspension Recalled for Discoloration
Sun Pharmaceutical recalls Pantoprazole Sodium oral suspension nationwide due to product discoloration. Lot MHC1317A with approximately 14,064 units was distributed in the USA.
Product
PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0070-2023·2022-11-30
Phenytoin Sodium Injection Recalled for Missing Vial Barcode
Acella Pharmaceuticals is recalling Phenytoin Sodium Injection because the primary vial label is missing a barcode. The recall affects 637 cartons distributed nationwide.
Product
PHENYTOIN SODIUM — PHENYTOIN SODIUM (PHENYTOIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0069-2023·2022-11-30
Phenytoin Sodium Injection Recalled for Missing Barcode on Vial Label
Acella Pharmaceuticals is recalling Phenytoin Sodium Injection due to missing barcodes on vial labels. The recall affects 574 cartons distributed nationwide.
Product
PHENYTOIN SODIUM — PHENYTOIN SODIUM (PHENYTOIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0066-2023·2022-11-23
Hand Sanitizer Recalled for Methanol Contamination — FDA Class I
Adam's Polishes ALCOHOL BASED HAND SANITIZER (multiple sizes) is recalled nationwide because FDA analysis found methanol contamination. This Class I recall poses a serious chemical health risk.
Product
Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0067-2023·2022-11-23
Adam's Polishes Hand Sanitizer Recalled for Methanol Contamination
Adam's Polishes hand sanitizer with 75% isopropyl alcohol is being recalled due to methanol contamination found in certain lots manufactured under non-compliant conditions. The product was distributed nationwide.
Product
Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0061-2023·2022-11-23
Phenoxybenzamine Hydrochloride Capsules Recalled for Failed Specifications
Par Pharmaceutical is recalling Phenoxybenzamine Hydrochloride Capsules 10mg nationwide due to failed impurity and degradation specifications. The recalled lot may not meet pharmaceutical quality standards.
Product
Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Forumulations Private Limited,9/215, Pudupakkam, Kelambakkam - 603 103. NDC 49884-038-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0063-2023·2022-11-23
Carvedilol Tablets 25 mg Recalled for Weight and Thickness Specification Failures
Viatris Inc is recalling 2,794 bottles of Carvedilol Tablets 25 mg nationwide because the tablets exceed FDA specifications for weight and thickness. Patients should verify their lot number and contact their pharmacist if affected.
Product
Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0060-2023·2022-11-23
ImprimisRx Timolol-Latanoprost Ophthalmic Drops Recalled for Subpotent Active Ingredient
ImprimisRx is recalling 960 bottles of compounded Timolol-Latanoprost ophthalmic drops nationwide. Affected batches contain less than 90% of the labeled latanoprost amount.
Product
Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0064-2023·2022-11-23
FDA Recalls Labetalol Injectable for Potential Cross-Contamination Risk
FDA recalls Nephron's Labetalol HCl Injection vials due to manufacturing deviations that could cause cross-contamination. The recall affects 34,020 vials distributed nationwide.
Product
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.
Category
Drug
Distribution
Distributed nationwide

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3251–3275 of 17762