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

2226–2250 of 11819

HighFDA (Drugs)·D-0130-2023·2023-01-11
Epi-Caine Intraocular Injection Recalled Due to Raw Material Discoloration
Pine Pharmaceuticals is recalling Epi-Caine intraocular injection (11,453 vials nationwide) due to discoloration in raw material used for compounding, a manufacturing quality control failure.
Product
Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded by Pine Pharmaceuticals, 355 Riverwalk Pkwy, Tonawanda, NY 14150. NDC 69194-0948-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0097-2023·2023-01-11
Heparin Sodium injectable bags recalled due to potential sterility assurance issues
Pfizer is recalling 62,088 bags of Heparin Sodium injection nationwide due to potential bag leakage that could compromise sterility. No illnesses have been reported.
Product
HEPARIN SODIUM — HEPARIN SODIUM (HEPARIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0095-2023·2023-01-11
Injectable Acyclovir Sodium Recalled for Particulate Matter Contamination
Eugia US LLC is recalling Acyclovir Sodium Injection (45,250 vials) distributed nationwide due to the presence of dark particles found inside vials.
Product
ACYCLOVIR SODIUM — ACYCLOVIR SODIUM (ACYCLOVIR SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0090-2023·2023-01-04
Ganciclovir injection vials contain mislabeled cladribine vials in cartons
Hikma Pharmaceuticals recalled Ganciclovir for Injection due to a labeling error where one vial per carton was mislabeled as Cladribine Injection, creating a risk of incorrect medication administration.
Product
GANCICLOVIR — GANCICLOVIR (GANCICLOVIR SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0092-2023·2023-01-04
Hand Sanitizer Recalled for Excess Chemical Impurities in Manufacturing
NCH Life Sciences LLC is recalling hand sanitizer products containing excess acetal and acetaldehyde impurities due to manufacturing deviations. The recall affects 2.5 and 55-gallon bottles distributed nationwide in the US and Canada.
Product
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03, Manufactured for: Multi-Mist Products A Division of NCH Corporation 1618 Northgat
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0091-2023·2023-01-04
Glycopyrrolate 1 mg Tablets Recalled for Failed Impurity Specifications
AVKARE LLC is recalling Glycopyrrolate 1 mg tablets distributed nationwide due to failed quality specifications involving unknown impurities. The recall affects 1,237 cartons.
Product
GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0088-2023·2022-12-28
Prescription Drug Quinapril Recalled for Chemical Impurity Exceeding Safety Limits
Lupin Pharmaceuticals is recalling Quinapril 40mg tablets due to detection of N-Nitroso-quinapril impurity above acceptable daily intake limits. The recall affects approximately 30,612 bottles distributed nationwide.
Product
QUINAPRIL — QUINAPRIL (QUINAPRIL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0089-2023·2022-12-28
Quinapril Tablets Recalled Due to Excess Impurity Above Limits
Lupin Pharmaceuticals is recalling Quinapril tablets (20 mg) due to N-nitroso-quinapril impurity detected above acceptable daily intake limits. The recall affects approximately 23,736 units distributed nationwide.
Product
QUINAPRIL — QUINAPRIL (QUINAPRIL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0087-2023·2022-12-28
Glycopyrrolate Tablets Recalled for Failed Impurities and Degradation Specifications
Glycopyrrolate tablets distributed nationwide are being recalled due to failed impurities and degradation specifications. Patients with affected lots should discontinue use and consult their healthcare provider.
Product
GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0085-2023·2022-12-28
Oxcarbazepine 600mg tablets recalled for foreign substance contamination
Sun Pharmaceutical is recalling three lots of Oxcarbazepine 600mg tablets due to the presence of foreign substances. The affected medication was distributed nationwide.
Product
OXCARBAZEPINE — OXCARBAZEPINE (OXCARBAZEPINE)
Category
Drug
Distribution
Distributed nationwide
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-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-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
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-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-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
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-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-0062-2023·2022-11-23
Injectable Sodium Chloride Recalled for Potential Container Leaks Compromising Sterility
ICU Medical is recalling 137,120 bags of 0.9% Sodium Chloride Injection because bags may leak and potentially compromise sterility. The affected lot (5829936) was distributed nationwide.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0154-2023·2022-11-23
Pedialyte Unflavored Electrolyte Solution Recalled for Seal Integrity Issues
Abbott Laboratories is recalling Pedialyte Unflavored Electrolyte Solution 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. The recall affects 14,588,544 bottles distributed in the US and internationally.
Product
Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case
Category
Drug
Distribution
50 states
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

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2226–2250 of 11819