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 17964

HighFDA (Drugs)·D-0124-2023·2023-01-18
Compounded Injectable Medication Recalled Due to Sterility Assurance Concerns
Northern VA Compounders is recalling QuadMix Injectable due to lack of assurance of sterility. The FDA Class II recall affects compounded injectable medication distributed nationwide.
Product
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0116-2023·2023-01-18
TriMix Injection Recalled Due to Lack of Sterility Assurance
Northern VA Compounders is recalling TriMix Injection due to lack of sterility assurance. The compounded injectable medication may not meet required sterility standards.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0106-2023·2023-01-18
Compounded TriMix Injectable Recalled for Lack of Sterility Assurance
Northern VA Compounders is recalling 750 vials of TriMix Original injectable nationwide due to lack of assurance of sterility. Patients should discontinue use and consult their healthcare provider.
Product
TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0108-2023·2023-01-18
Compounded Injectable Drug Recalled Due to Lack of Sterility Assurance
Northern VA Compounders has recalled QuadMix Super 002 injectable medication due to lack of assurance of sterility. The affected lot is distributed nationwide.
Product
QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0103-2023·2023-01-18
QuadMix Plus Injectable Medication Recalled for Lack of Sterility Assurance
Northern VA Compounders is recalling QuadMix Plus injectable medication due to lack of assurance of sterility. The recall affects 78 vials distributed nationwide.
Product
QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0121-2023·2023-01-18
TriMix Injection Recalled Nationwide for Lack of Sterility Assurance
Northern VA Compounders recalls TriMix Injectable due to lack of sterility assurance in 8 vials distributed nationwide. Patients should consult their healthcare provider about affected doses.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0114-2023·2023-01-18
TriMix Injection Recalled Due to Sterility Assurance Failure
Northern VA Compounders is recalling TriMix Injection due to lack of assurance of sterility. The affected lot (11142022@11, exp. 12/29/2022) was distributed nationwide. No illnesses have been reported.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0101-2023·2023-01-18
Moxifloxacin Ophthalmic Solution Recalled Due to Manufacturing Quality Deviation
Direct Rx recalled 11 bottles of Moxifloxacin Ophthalmic Solution (0.5%, 3 mL) due to a cGMP deviation and discontinued stability support.
Product
Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05
Category
Drug
Distribution
1 state
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-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-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
ModerateFDA (Drugs)·D-0096-2023·2023-01-11
Prochlorperazine Maleate tablets recalled for subpotency: out of specification at stability testing
Jubilant Cadista Pharmaceuticals recalls 14,061 bottles of Prochlorperazine Maleate 5mg tablets nationwide due to subpotency. The medication failed quality testing at 18 months and contains less active ingredient than specified.
Product
PROCHLORPERAZINE MALEATE — PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE)
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-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-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
ModerateFDA (Drugs)·D-0093-2023·2023-01-04
Timolol Maleate Ophthalmic Solution recalled for failed stability specifications
Apotex Corp. is recalling Timolol Maleate Ophthalmic Solution 0.5% (lot TA4844) nationwide due to failed stability specifications showing excessive weight loss that may affect medication potency.
Product
Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg for: Apotex Corp. Weston, FL 33326, NDC 60505-1005-4
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-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
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-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
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
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
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-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

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3251–3275 of 17964