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

951–975 of 11852

HighFDA (Drugs)·D-0594-2024·2024-07-17
Compounded Lidocaine-Epinephrine Injectable Recalled Nationwide for Subpotent Epinephrine
Tailstorm Health Inc is recalling a compounded lidocaine-epinephrine injection nationwide due to subpotent epinephrine component. The recall affects 12,525 vials of lot number 2311003.
Product
Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0585-2024·2024-07-10
RAM IT Horny Goat Weed Dietary Supplement Recalled for Undeclared Sildenafil
Integrity Products recalls RAM IT Horny Goat Weed dietary supplement capsules nationwide because they contain undeclared sildenafil, a prescription drug not listed on the label.
Product
RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0586-2024·2024-07-10
Horny Goat Weed Capsules Recalled for Undeclared Sildenafil
To the Moon Capsules are being recalled nationwide because they contain undeclared sildenafil, a prescription pharmaceutical. The product was marketed without FDA approval.
Product
To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0574-2024·2024-07-10
FDA recalls Dream Cream topical product due to manufacturing quality violations
Little Moon Essentials voluntarily recalls Dream Cream due to manufacturing quality control violations. No illnesses reported.
Product
Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5, NDC 70722-232-02; b) 4OZ (113G) glass jar, UPC Code 6 73673 88804 8, NDC 70722-232-04; Little Moon Essentials LLC Dania Beach, Fl 33004
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0570-2024·2024-07-10
Budesonide USP drug ingredient recalled for glass contamination
Medisca Inc. is recalling 113 bottles of Budesonide, USP (Micronized) 500 mg due to glass particulate matter contamination caused by manufacturing deviations. The product was distributed nationwide in the USA and Canada.
Product
Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0582-2024·2024-07-10
Sun Pharmaceutical Recalls Decitabine Injection for Microbial Contamination
Sun Pharmaceutical is recalling Decitabine for Injection (lot HAD2964A, 2,088 vials) for a Current Good Manufacturing Practice deviation. The Total Aerobic Microbial Count test on unfiltered bulk was out of specification; the product was distributed nationwide.
Product
Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0583-2024·2024-07-10
Allopurinol tablets recalled due to presence of foreign substance
Dr. Reddy's Laboratories is recalling Allopurinol 300mg tablets due to the presence of a foreign substance. Approximately 20,520 units were distributed in Illinois, Mississippi, and Ohio.
Product
ALLOPURINOL — ALLOPURINOL (ALLOPURINOL)
Category
Drug
Distribution
3 states
HighFDA (Drugs)·D-0579-2024·2024-07-10
Methylphenidate Hydrochloride Extended-Release Tablets Recalled for Failed Dissolution
Trigen Laboratories recalls Methylphenidate Hydrochloride Extended-Release Tablets (36mg) because a batch failed dissolution specifications. Approximately 10,448 bottles were distributed nationwide.
Product
METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0568-2024·2024-07-03
Duloxetine Prescription Capsules Recalled Nationwide for Nitrosamine Impurity
Golden State Medical Supply is recalling Duloxetine 30mg capsules nationwide due to contamination with N-nitroso-duloxetine, a nitrosamine impurity above the FDA's proposed safety limit. Affected lots expire January 31, 2025.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0567-2024·2024-07-03
Pacira Pharmaceuticals Recalls Zilretta Injectable Suspension for Failed Dissolution Testing
Pacira Pharmaceuticals recalls Zilretta intra-articular injectable suspension nationwide after the product failed dissolution specifications in stability testing.
Product
ZILRETTA — ZILRETTA (TRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSION)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0563-2024·2024-07-03
Progesterone 200 mg compounded tablets recalled for embedded metal fragments
Coast Quality Pharmacy is recalling Progesterone 200 mg compounded sublingual tablets nationwide due to discovery of broken metal pieces embedded in tablets. Patients should contact their healthcare provider.
Product
Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, 5710 Hoover Blvd, Tampa, Fl 33643, (800)-995-4363. Beyond Use Date: 09/08/2024.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0564-2024·2024-07-03
Buprenorphine Injection Recalled Due to Incomplete Seal Integrity Issue
Pfizer is recalling specific lots of Buprenorphine Hydrochloride Injection due to potential incomplete crimp seals that could compromise product sterility. Patients using affected lots should consult their healthcare provider.
Product
BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0565-2024·2024-07-03
Injectable Labetalol Hydrochloride Recalled Due to Incomplete Crimp Seals
Pfizer recalls 220,400 cartridges of Labetalol Hydrochloride injection due to potential incomplete crimp seals that could compromise sterility. Affected lots should not be used; healthcare providers should contact Pfizer for guidance.
Product
LABETALOL HYDROCHLORIDE — LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0558-2024·2024-06-26
OSSOS-SANS tablets recalled: undeclared diclofenac and methocarbamol found
OSSOS-SANS Reforzado tablets are being recalled because they contain undeclared active pharmaceutical ingredients—diclofenac and methocarbamol—and were marketed without FDA approval.
Product
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados, Alce Blanco 180-A Fracc. Industrial, Edo. de Mexico C.P. 53370
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0562-2024·2024-06-26
Prescription Drug Duloxetine Recalled for Nitrosamine Impurity Exceeding FDA Limits
Breckenridge Pharmaceutical recalls Duloxetine 60mg capsules nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA interim limits. Affected lots had current good manufacturing practice (CGMP) deviations.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0557-2024·2024-06-26
Little Remedies Gas Relief Drops Class II Recall for Manufacturing Deviations
Denison Pharmaceuticals recalls 113,544 bottles of Little Remedies Gas Relief Drops (Lot #0855, exp. 8/31/2025) due to manufacturing deviations. All units have been recovered and controlled at the manufacturer.
Product
LITTLE REMEDIES — LITTLE REMEDIES (SIMTHICONE)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0559-2024·2024-06-26
Cefixime Oral Suspension Recalled for Failed Content Uniformity Specifications
Lupin Pharmaceuticals is recalling one lot of Cefixime oral suspension (200 mg/5 mL) due to failed content uniformity specifications. The recall affects 3,552 bottles distributed nationwide.
Product
CEFIXIME — CEFIXIME (CEFIXIME)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0555-2024·2024-06-26
FDA Recalls Dexamethasone Sodium Phosphate Injection Due to Impurity Specification Failure
Eugia US LLC recalls 70,125 vials of Dexamethasone Sodium Phosphate injection due to failed impurity specifications. Testing found sulfonic acid adduct of dexamethasone phosphate exceeded allowed limits.
Product
DEXAMETHASONE SODIUM PHOSPHATE — DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0560-2024·2024-06-26
White Petrolatum Jelly Mislabeled With Undisclosed Lavender and Chamomile
Consumer Product Partners is recalling Pure Petroleum white petrolatum products sold at Rite Aid, Kroger, Harris Teeter, and CVS nationwide because the products labeled as pure white petrolatum actually contain undisclosed lavender and chamomile.
Product
PURE PETROLEUM — PURE PETROLEUM (WHITE PETROLATUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0561-2024·2024-06-26
Teva Recalls Amoxicillin-Clavulanate Antibiotic Tablets Due to Subpotency
Teva Pharmaceuticals is recalling 34,448 bottles of Amoxicillin and Clavulanate Potassium Tablets USP (Chewable 400mg/57mg) distributed nationwide due to subpotency. The recall is voluntary and initiated by the firm.
Product
Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-2272-34
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0554-2024·2024-06-19
Docetaxel Injection Recalled Nationwide for Stopper Particulate Matter
Sagent Pharmaceuticals is recalling Docetaxel Injection due to particulate matter from the vial stopper contaminating the drug. The recall affects 2,806 vials distributed nationwide.
Product
DOCETAXEL — DOCETAXEL (DOCETAXEL ANHYDROUS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0553-2024·2024-06-19
Docetaxel Injection Recalled Due to Particulate Matter in Stopper
Sagent Pharmaceuticals is recalling Docetaxel Injection due to particulate matter from the vial stopper. Lot F1040001 was distributed nationwide.
Product
DOCETAXEL — DOCETAXEL (DOCETAXEL ANHYDROUS)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0547-2024·2024-06-19
Klarity-C Ophthalmic Emulsion Recalled Due to Sterility Assurance Risk
Imprimis is recalling Klarity-C, a cyclosporine eye medication, because the company cannot assure the product meets sterility standards. Approximately 136,005 units were distributed nationwide.
Product
Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY Compounded by: Imprimis NJOF, LLC., 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852 NDC: 71384-514-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0545-2024·2024-06-19
Prescription Drug Recall: Phenazopyridine Tablets Contain Wrong Medication
Winder Laboratories is recalling Phenazopyridine HCl tablets (Lot #1142404) due to a product mix-up where some bottles contain Phenobarbital tablets instead. No illnesses or injuries have been reported.
Product
PHENAZOPYRIDINE HYDROCHLORIDE — PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0546-2024·2024-06-19
Zilretta Injectable Drug Recalled for Failed Stability Specifications
Pacira Pharmaceuticals is recalling 43,768 kits of Zilretta injectable suspension due to failed stability specifications at 2–8°C storage for 12 months followed by 25°C for 6 weeks. No illnesses or injuries have been reported.
Product
ZILRETTA — ZILRETTA (TRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSION)
Category
Drug
Distribution
Distributed nationwide

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951–975 of 11852