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

3151–3175 of 17762

HighFDA (Drugs)·D-0234-2023·2023-02-01
Injectable Prostaglandin E1 Multiple Strengths Recalled for Sterility Concerns
Pharmacy Innovations is recalling multiple strengths of injectable Prostaglandin E1 nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.
Product
PROSTAGLANDIN (PE1) 45MCG (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 17MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 20MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 22.5MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 23MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 30MCG/ML (1ML VIAL) I
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0215-2023·2023-02-01
Injectable hydroxocobalamin vials recalled due to sterility concerns
Pharmacy Innovations is recalling hydroxocobalamin-PF injectable vials (1mg/ml) distributed nationwide because FDA inspection found insanitary conditions at the manufacturing facility that could compromise product sterility.
Product
HYDROXOCOBALAMIN-PF- 1MG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0168-2023·2023-02-01
Allopurinol Tablets Recalled for Green Plastic Contamination
Accord Healthcare is recalling Allopurinol 100 mg tablets due to the presence of a small piece of green plastic embedded in some tablets. The plastic poses a potential choking and ingestion hazard.
Product
ALLOPURINOL — ALLOPURINOL (ALLOPURINOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0228-2023·2023-02-01
Multiple injectable medications recalled for sterility assurance concerns
Pharmacy Innovations recalls multiple injectable medications nationwide due to insanitary facility conditions compromising sterility assurance. FDA inspection revealed conditions creating risk to medication safety.
Product
PE1/PAPAV/PHEN 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 30MCG/30MCG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 5.88MCG/17.65MG/0.588MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT (1ML) 10MCG/30MG/2MG/ML INJECTABLE PE1/PAPAV/PHENT 10MCG/18MG/1MG/ML (1ML VIAL) INJECTABL
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0240-2023·2023-02-01
Antibiotic Eye Drops Recalled for Sterility Assurance Failure
Pharmacy Innovations is recalling Tobramycin Fortified 15mg/mL Ophthalmic Solution nationwide due to insanitary facility conditions that compromised sterility assurance. Consumers should discontinue use and contact their healthcare provider.
Product
TOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0199-2023·2023-02-01
Clindamycin/EDTA Calcium Irrigation Solution Recalled for Lack of Sterility Assurance
Pharmacy Innovations is recalling Clindamycin/EDTA Calcium irrigation solution (30ML syringe) distributed nationwide due to lack of assurance of sterility caused by insanitary conditions found during FDA inspection.
Product
Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0194-2023·2023-02-01
Atropine sulfate eye drops recalled due to facility sterility concerns
Pharmacy Innovations recalls two concentrations of atropine sulfate eye drops due to insanitary facility conditions discovered by FDA inspection. The products were distributed nationwide.
Product
Atropine sulfate 0.05%, 1ML dropper, and Atropine sulfate 0.01%, 1 ML dropper, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0171-2023·2023-02-01
Metoprolol Succinate Extended-Release Tablets Recalled for Failed Dissolution Specification
Ascend Laboratories is recalling 2,628 bottles of Metoprolol Succinate Extended-Release Tablets (50 mg) nationwide due to failed dissolution specification. The tablets may not dissolve properly, preventing proper medication absorption.
Product
METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0233-2023·2023-02-01
Pharmacy Innovations Progesterone Injectable Vial Recalled for Sterility Concerns
Pharmacy Innovations is recalling PROGESTERONE-GS OIL 100MG/ML injectable vials distributed nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.
Product
PROGESTERONE-GS OIL- 100MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0225-2023·2023-02-01
Injectable NADH Recalled for Sterility Concerns at Manufacturing Facility
Pharmacy Innovations is recalling NADH 10MG/ML injectable vials distributed nationwide due to lack of assurance of sterility. FDA inspection revealed insanitary conditions at the facility.
Product
NADH 10MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0229-2023·2023-02-01
Phenol 10% Injectable Vials Recalled for Sterility Assurance Failure
Pharmacy Innovations recalls Phenol 10% injectable vials distributed nationwide due to insanitary conditions at the manufacturing facility that compromised sterility assurance.
Product
PHENOL 10% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0202-2023·2023-02-01
Injectable Drug Recall: Lack of Sterility Assurance at Manufacturing Facility
Pharmacy Innovations is recalling an injectable medication due to lack of sterility assurance caused by insanitary conditions at the manufacturing facility. Affected vials were distributed nationwide.
Product
Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML (1ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0178-2023·2023-02-01
Sterile water injection vials recalled for trace product carryover risk
Nephron Pharmaceuticals recalls approximately 389,730 vials of sterile water for injection nationwide due to potential product carryover from manufacturing deviations. No illnesses have been reported.
Product
STERILE WATER — STERILE WATER (STERILE WATER)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0193-2023·2023-02-01
Pharmacy Innovations Apomorphine Injectable Recalled for Sterility Assurance Failure
Pharmacy Innovations is recalling Apomorphine HCL 2MG/ML injectable vials nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.
Product
Apomorphine HCL 2MG/ML (10ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0237-2023·2023-02-01
Tacrolimus Ophthalmic Solutions Recalled for Sterility Assurance Issues
Pharmacy Innovations recalls Tacrolimus ophthalmic solutions nationwide due to potential sterility assurance issues from insanitary facility conditions found during FDA inspection.
Product
TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION TACROLIMUS -CORN OIL- 0.03% OPH SOLUTION TACROLIMUS-VET- 0.02% (10ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (15ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (5ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0176-2023·2023-02-01
Drug Recall: S2 Racepinephrine Inhalation Solution Short Fill
Nephron Sc Inc recalls approximately 925,920 vials of S2 Racepinephrine Inhalation Solution due to short fill. Affected lots may contain less medication than labeled.
Product
S2 — S2 (RACEPINEPHRINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0172-2023·2023-02-01
FDA Recalls Fentanyl Injection Solution for Underfilled Cassettes
OurPharma LLC is recalling 768 cassettes of FentaNYL Citrate injection solution due to underfilled units. The affected product was distributed in Illinois and Missouri.
Product
FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1001-01.
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0174-2023·2023-02-01
Clobetasol Propionate Cream recalled due to subpotent drug
Lupin Pharmaceuticals is recalling Clobetasol Propionate Cream 0.05% nationwide because stability testing revealed insufficient active ingredient in the affected lot.
Product
CLOBETASOL PROPIONATE — CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0170-2023·2023-02-01
Metoprolol Succinate Tablets Recalled for Failed Dissolution Specification
Ascend Laboratories is recalling 6,336 bottles of Metoprolol Succinate Extended-Release Tablets, 50 mg, distributed nationwide and in Puerto Rico, due to failed dissolution specification.
Product
METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0131-2023·2023-01-25
Daptomycin for Injection Recalled Due to Incorrect Labeling Dosage
Accord Healthcare is recalling Daptomycin for Injection labeled as 350 mg/vial but containing 500 mg/vial vials. The labeling error poses a dosing risk to patients.
Product
Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0133-2023·2023-01-25
Drug Recall: Artificial Tears Eye Ointment Due to Manufacturing Deviations
Akorn, Inc. is recalling Artificial Tears Ointment (1.16 million tubes nationwide) due to manufacturing practice deviations. The firm voluntarily initiated this recall.
Product
Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0139-2023·2023-01-25
FDA Recalls Nationwide Supply of Erythromycin Ophthalmic Ointment for Manufacturing Deviations
Akorn, Inc. is recalling 36,455 cartons of Erythromycin Ophthalmic Ointment USP 0.5% nationwide due to manufacturing process deviations. The company voluntarily initiated this Class II recall.
Product
Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0128-2023·2023-01-25
Prescription Anesthetic Drug Recalled for Subpotent Epinephrine Content
Fresenius Kabi is recalling Sensorcaine anesthetic injections nationwide due to subpotent epinephrine content. Affected batches may not provide adequate anesthesia or hemostasis during procedures.
Product
SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0147-2023·2023-01-25
Eye drop medication Olopatadine HCl recalled nationwide for manufacturing deviations
Akorn, Inc. is recalling 31,073 bottles of Olopatadine HCl ophthalmic solution nationwide due to current good manufacturing practice deviations. This voluntary recall was initiated by the manufacturer.
Product
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0135-2023·2023-01-25
Betaxolol ophthalmic solution recalled for manufacturing process violations
Akorn, Inc. is voluntarily recalling Betaxolol ophthalmic solution (6,273 bottles, lot 1A08A, exp. 12/31/2022) due to manufacturing deviations. Consumers should consult their healthcare provider.
Product
Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-705-10
Category
Drug
Distribution
Distributed nationwide

How to read this listing

Filters

3151–3175 of 17762