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

1076–1100 of 5047

HighFDA (Drugs)·D-0277-2025·2025-03-26
Duloxetine Delayed-Release Capsules Recalled for N-Nitroso Impurity Above Safe Levels
Rising Pharma is recalling Duloxetine Delayed-Release Capsules 30 mg (Lot DTB23111A) distributed nationwide due to N-nitroso-duloxetine impurity above the FDA's recommended interim limit. This manufacturing impurity resulted from a CGMP deviation.
Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0278-2025·2025-03-26
Cinacalcet Hydrochloride Tablets Recalled for Nitrosamine Impurity
Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 30 mg due to nitrosamine impurity above acceptable daily intake limits. 56,790 bottles were distributed to 8 wholesalers nationwide.
Product
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0291-2025·2025-03-26
FDA Recalls Super-Potent Levothyroxine Sodium Tablets Due to Potency Deviation
Mylan Institutional is recalling 1,068 cartons of levothyroxine sodium 125 mcg tablets (Lot 3115773) distributed nationwide due to out-of-specification potency. The tablets contain higher-than-specified amounts, potentially resulting in excessive doses.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0286-2025·2025-03-26
Injectable Drug Recalled for Stability Issues at Expiration
Amgen recalls 258,750 vials of Neupogen (filgrastim) injection due to stability concerns. Stability data shows products may be out of specification at expiration; patients should consult healthcare providers about affected lots.
Product
NEUPOGEN — NEUPOGEN (FILGRASTIM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0279-2025·2025-03-26
Cinacalcet Hydrochloride Tablets Recalled for Nitrosamine Impurity Above Safe Limits
Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 60 mg for containing nitrosamine impurity above acceptable daily intake limits. The recall affects 2,444 bottles distributed nationwide.
Product
Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0283-2025·2025-03-26
Walgreens Acne Cream Recalled for Benzene Contamination
Walgreens Maximum Strength Tinted Acne Treatment Cream is being recalled for benzene contamination. The product was distributed nationwide; affected consumers should stop use immediately.
Product
Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0285-2025·2025-03-26
Neupogen Injectable Drug Recalled for Potential Stability Issues at Expiration
Amgen is recalling Neupogen (filgrastim) injectable vials due to stability concerns. Stability data indicates the product may be out of specification at its expiration date.
Product
NEUPOGEN — NEUPOGEN (FILGRASTIM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0287-2025·2025-03-26
FDA Recalls Prasugrel Tablets for Failed Dissolution Specifications
Golden State Medical Supply Inc. is recalling 2,601 bottles of Prasugrel 5 mg tablets due to failed dissolution specifications. The tablets may not dissolve properly, potentially affecting drug absorption.
Product
PRASUGREL — PRASUGREL (PRASUGREL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0290-2025·2025-03-26
Levothyroxine Sodium Tablets Recalled for Out-of-Specification Potency
Mylan Institutional is recalling Levothyroxine Sodium Tablets 150 mcg due to out-of-specification potency. The medication tested higher than specified, affecting 347 cartons distributed nationwide (Lot 3116074, expires 09/30/2025).
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0289-2025·2025-03-26
FDA Recalls Subpotent CURAD Alcohol Prep Pads Nationwide
Medline Industries is recalling CURAD Alcohol Prep Pads nationwide because they are subpotent. The recalled pads are sterile, medium, 2-ply alcohol prep pads distributed nationally.
Product
CURAD ALCOHOL PREP PADS — CURAD ALCOHOL PREP PADS (ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0282-2025·2025-03-26
Ciprofloxacin Ophthalmic Solution Recalled Nationwide for Defective Container Cap
Ciprofloxacin Ophthalmic Solution is being recalled because the cap spike is lodged in the bottle nozzle, preventing patients from accessing the medication. Affected lot 084A067 was distributed nationwide.
Product
CIPROFLOXACIN — CIPROFLOXACIN (CIPROFLOXACIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0288-2025·2025-03-26
Medline Alcohol Prep Pads Recalled for Subpotent Isopropyl Alcohol
Medline Industries has voluntarily recalled over 6.6 million alcohol prep pads nationwide because the product contains less isopropyl alcohol than labeled. The subpotent product was first reported on March 26, 2025.
Product
MEDLINE ALCOHOL PREP — MEDLINE ALCOHOL PREP (ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0259-2025·2025-03-19
ChloraPrep One-Step Topical Drug Recalled for Fungal Contamination
CareFusion 213, LLC is recalling ChloraPrep One-Step, a preoperative skin preparation drug, due to non-sterility from a package lidding breach allowing fungal contamination. The recall affects 205,440 applicators distributed nationwide and in Canada.
Product
CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0272-2025·2025-03-19
Injectable Phenylephrine Solution Recalled Due to Particulate Matter Contamination
The FDA is recalling phenylephrine injection solution due to particulate matter contamination. Three lot numbers distributed nationwide are affected.
Product
PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0268-2025·2025-03-19
Potassium Chloride Injection Strength Mislabeled on Packaging Overwrap
ICU Medical recalls Potassium Chloride Injection (lot 1023172) whose overwrap labeled as 10 mEq may contain 20 mEq containers, creating overdose risk. Product distributed nationwide.
Product
POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0267-2025·2025-03-19
Potassium Chloride Injection Recalled: Overwrap Labeling Shows Incorrect Strength
ICU Medical recalls Potassium Chloride 20 mEq IV injection due to mislabeled overwrap showing 10 mEq instead of the correct strength. The correct dose is printed on the actual container.
Product
POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0273-2025·2025-03-19
Acne treatment gel recalled for benzene contamination nationwide
Zapzyt Acne Treatment Gel (10% benzoyl peroxide) distributed nationwide is being recalled due to contamination with benzene. Consumers should stop using affected lots immediately.
Product
ZAPZYT ACNE TREATMENT GEL — ZAPZYT ACNE TREATMENT GEL (BENZOYL PEROXIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0271-2025·2025-03-19
Duloxetine Capsules Recalled for N-Nitroso Impurity Exceeding FDA Limits
Breckenridge Pharmaceutical is recalling 11,125 bottles of Duloxetine 20mg capsules nationwide due to N-nitroso-duloxetine impurity above FDA-recommended limits. The impurity was detected during quality control testing.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0266-2025·2025-03-19
Unisom SleepMelts Sleep-Aid Tablets Recalled for Nitrosamine Impurity
Chattem Inc. is recalling Unisom SleepMelts diphenhydramine HCl 25 mg tablets nationwide due to a nitrosamine impurity detected above FDA's acceptable daily intake limit. Affected lots expire between May 2025 and April 2026.
Product
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0269-2025·2025-03-19
Duloxetine 60mg Capsule Recall Due to Manufacturing Impurity
Breckenridge Pharmaceutical recalls 11,100 bottles of Duloxetine 60mg capsules distributed nationwide due to the presence of N-nitroso-duloxetine impurity exceeding FDA recommended interim limits from manufacturing deviations.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0263-2025·2025-03-19
Chemotherapy drug Chlorambucil recalled for manufacturing process deviations
Aspen Biopharma Labs is voluntarily recalling Chlorambucil due to manufacturing process deviations. The product was distributed to distributors in Hong Kong and Florida.
Product
Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0261-2025·2025-03-19
Drug Recall: Alprostadil Affected by Manufacturing Practice Deviations
Alprostadil 3.0 gm is being recalled due to manufacturing practice deviations. Limited distribution affects product with lot number HAALC0020922 (expiration August 2025).
Product
Alprostadil Container Description: Amber color bottle
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0264-2025·2025-03-19
Latanoprost medication recalled due to manufacturing practice deviations
Aspen Biopharma Labs is recalling Latanoprost medication due to manufacturing practice deviations. The voluntary recall affects product distributed to distributors in Hong Kong and Florida.
Product
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0257-2025·2025-03-19
Sodium Chloride Injection Recalled for Potential Sterility Compromise
Nephron Sterile Compounding Center is recalling Sodium Chloride Injection 9% due to potential leakage at the IV bottle port, which could compromise sterility. Affected lots were distributed nationwide.
Product
Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0270-2025·2025-03-19
Duloxetine 30mg Delayed-Release Capsules Recalled for N-Nitroso Impurity
Breckenridge Pharmaceutical recalls 14,749 bottles of duloxetine 30mg delayed-release capsules due to N-nitroso impurity above FDA safety limits. Patients taking this medication should contact their healthcare provider to verify if their prescription is affected.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide

How to read this listing

Filters

1076–1100 of 5047