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

1301–1325 of 3644

HighFDA (Drugs)·D-0520-2024·2024-06-05
Pain Wizard Topical Pain Relief Recalled for Out-of-Specification Active Ingredient
ARG Laboratories recalls Pain Wizard topical pain relief nationwide due to out-of-specification active ingredient and violative-grade propylene glycol used in manufacturing. No illnesses reported.
Product
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Bottle with pump, NET WT 16 fluid oz / 473.17 ml, Made in USA, www.painwizard.com Pain Wizard LLC.PO Box 1099, Johnstown, CO 80534, UPC 8 63865
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0515-2024·2024-06-05
Moxifloxacin intraocular injection vials recalled for sterility assurance failure
Imprimis NJOF, LLC recalls Moxifloxacin intraocular injection vials nationwide due to lack of sterility assurance. The 18,980 affected vials (lot 23OCT013) should not be used.
Product
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0529-2024·2024-06-05
Golden Tiger Pain Relief Cream Recalled for Out-of-Specification Active Ingredient
ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to the active ingredient being out of specification and improper grade propylene glycol being used during manufacturing.
Product
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Roll-On NET WT 3 fl. oz. (88.7ml), Manufactured for Golden Tiger USA Albuquerque, NM, UPC 1 82294 00006 2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0526-2024·2024-06-05
Golden Tiger Pain Relief Cream Recalled for Out-of-Specification Ingredients
ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to an active ingredient that does not meet specifications and violative grade propylene glycol used during manufacturing.
Product
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark & MSM, Bottle with Pump NET WT 32 fl. oz (946.33ml), Manufactured for Golden Tiger LLC Made in USA, UPC 1 82294 00004 8
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0508-2024·2024-05-29
Phenylephrine Injection Recalled Due to Ephedrine Label Mix-Up
Hikma Injectables USA Inc is recalling phenylephrine injection syringes that were mislabeled as containing ephedrine. The mix-up creates a serious risk of administering the wrong medication to patients.
Product
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
Category
Drug
Distribution
5 states
HighFDA (Drugs)·D-0505-2024·2024-05-29
Duloxetine Delayed-Release Capsules Recalled for Nitrosamine Impurity
Preferred Pharmaceuticals is recalling 66 bottles of Duloxetine 30mg capsules (Lot J2022G) due to manufacturing deviations that resulted in N-nitroso-duloxetine impurity above FDA limits.
Product
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Category
Drug
Distribution
5 states
HighFDA (Drugs)·D-0507-2024·2024-05-29
FDA Recalls Vasopressin Injection for Subpotency and Out-of-Specification Impurities
American Regent Inc. is recalling Vasopressin Injection nationwide because some vials are subpotent and contain out-of-specification impurities.
Product
VASOPRESSIN — VASOPRESSIN (VASOPRESSIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0506-2024·2024-05-29
Haloperidol Decanoate Injections Recalled for Trace Water Contamination
Somerset Therapeutics is recalling Haloperidol Decanoate injections nationwide due to the potential presence of trace amounts of water in some vials, which may affect product quality.
Product
HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0494-2024·2024-05-22
Dietary Supplement Marketed as Unapproved Drug Without FDA Approval
Stop Clopez Corp's Schwinnng Herbal Dietary Supplement Capsules were distributed worldwide via Amazon without FDA approval as a new drug. Consumers should discontinue use immediately.
Product
Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV.
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0496-2024·2024-05-22
Antibiotic Cefdinir Oral Suspension Recalled for Foreign Material Contamination
Lupin Pharmaceuticals is recalling Cefdinir Oral Suspension USP 250 mg/5 mL (Lot F305442, expiration 8/30/2025) due to foreign material found in reconstituted bottles. Approximately 17,070 bottles were distributed nationwide.
Product
CEFDINIR — CEFDINIR (CEFDINIR)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0497-2024·2024-05-22
Antibiotic Cefdinir Oral Suspension Recalled Over Foreign Material
Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to foreign material found in reconstituted bottles. This FDA Class II recall affects 17,040 bottles distributed nationwide.
Product
CEFDINIR — CEFDINIR (CEFDINIR)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0499-2024·2024-05-22
Prescription Corticosteroid Injectable Recalled for Particulate Matter
Sagent Pharmaceuticals recalls methylprednisolone acetate injectable suspension due to potential black particulates in the drug product. Four affected lots were distributed nationwide.
Product
METHYLPREDNISOLONE ACETATE — METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE ACETATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0498-2024·2024-05-22
Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Foreign Plastic Contamination
Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets (50 mg/12.5 mg, lot BLK2304A) due to the presence of a plastic-like foreign substance. The recall affects 1,048 bottles distributed nationwide.
Product
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0485-2024·2024-05-15
Prescription Drug Javygtor Recalled for Sub-Potency and Powder Discoloration
Dr. Reddy's Laboratories is recalling Javygtor powder packets nationwide due to powder discoloration and sub-potency. The recall affects 17,332 cartons with multiple lot numbers.
Product
JAVYGTOR — JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0486-2024·2024-05-15
Sapropterin Dihydrochloride Powder for Oral Solution Recalled Due to Sub-Potency
Dr. Reddy's Laboratories is recalling 2,402 cartons of Sapropterin Dihydrochloride Powder 100mg due to sub-potency associated with powder discoloration. The affected lot (T2200352) was distributed nationwide.
Product
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0489-2024·2024-05-15
TraMADol HCl 50 mg Tablets Recalled for Foreign Baclofen Tablets
RemedyRepack Inc. is recalling TraMADol HCl 50 mg tablets nationwide after a pharmacist discovered a baclofen tablet in a tramadol bottle. Taking the wrong medication poses serious health risks.
Product
TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0483-2024·2024-05-15
Duloxetine delayed-release capsules recalled for manufacturing impurity exceeding limits
Breckenridge Pharmaceutical recalls Duloxetine 20 mg capsules nationwide after detecting N-nitroso-duloxetine impurity above FDA-recommended limits in approximately 7,188 units from lot 220456, expiring February 2025.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0484-2024·2024-05-15
Prescription Duloxetine 60 mg capsules recalled for N-nitroso impurity
Breckenridge Pharmaceutical is recalling Duloxetine 60 mg capsules due to elevated levels of N-nitroso-duloxetine, a manufacturing impurity above FDA limits. No illnesses have been reported.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0488-2024·2024-05-15
Timolol Maleate ophthalmic solution recalled for defective container cap nozzle
FDC Limited is recalling Timolol Maleate Ophthalmic Solution 0.5% distributed in New Jersey due to defective bottle caps with yellow spikes that can lodge in the nozzle, posing a risk of eye injury.
Product
TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0487-2024·2024-05-15
Tramadol Hydrochloride Tablets Recalled Due to Baclofen Contamination
Advagen Pharma is recalling Tramadol Hydrochloride Tablets after a pharmacy discovered baclofen tablets mixed in a bottle of tramadol. This nationwide recall affects 2,592 bottles.
Product
TRAMADOL HYDROCHLORIDE — TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0482-2024·2024-05-15
Duloxetine prescription capsules recalled for N-nitroso impurity exceeding FDA limits
Breckenridge Pharmaceutical recalls Duloxetine 30mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA-recommended interim limits. The impurity was identified as a CGMP manufacturing deviation.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0493-2024·2024-05-15
Prescription antifungal injection product recalled for out-of-specification assay
Sun Pharmaceutical is recalling Amphotericin B for Injection (50 mg vials) due to out-of-specification assay results. The recall affects 11,016 vials with lot numbers BAE0055A, BAE0056A, and BAE0068A distributed nationwide.
Product
AMPHOTERICIN B — AMPHOTERICIN B (AMPHOTERICIN B)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0476-2024·2024-05-08
FDA Issues Nationwide Recall of Subpotent Ophthalmic Eye Drops
The FDA is recalling 3,320 bottles of compounded ophthalmic solution due to subpotency. The affected product does not contain adequate amounts of active medication.
Product
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0479-2024·2024-05-08
EYLEA injection recalled for sterility concerns and syringe breakage complaints
Regeneron Pharmaceuticals recalled over 251,000 EYLEA (aflibercept) injection syringes distributed nationwide due to complaints of syringe breakage and concerns about sterility assurance in specific lots.
Product
EYLEA — EYLEA (AFLIBERCEPT)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0477-2024·2024-05-08
Methylergonovine Maleate tablets recalled for failed dissolution specifications
Amneal Pharmaceuticals recalls Methylergonovine Maleate 0.2mg tablets nationwide due to failed dissolution specifications. The tablets may not dissolve properly, potentially reducing medication effectiveness.
Product
METHYLERGONOVINE MALEATE — METHYLERGONOVINE MALEATE (METHYLERGONOVINE)
Category
Drug
Distribution
Distributed nationwide

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1301–1325 of 3644