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

701–725 of 11803

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-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
1 state
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
1 state
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
1 state
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
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-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-0274-2025·2025-03-19
Walgreens Acne Control Cleanser recalled for benzene contamination
Walgreens Acne Control Cleanser with 10% benzoyl peroxide is being recalled nationwide due to benzene contamination. The affected lot (23-09328, exp. 09/2025) was distributed across the U.S.
Product
Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0276-2025·2025-03-19
Kids by babyganics mineral sunscreen recalled for chemical contamination
Kids by babyganics SPF 50 mineral sunscreen spray is being recalled due to chemical contamination. Consumers using affected batches should stop use immediately.
Product
Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813277019923 and UPC 813277019916
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0254-2025·2025-03-12
Morphine Sulfate Oral Syringes Recalled for Defective Delivery System Leakage
Safecor Health is recalling Morphine Sulfate 5 mg oral syringes nationwide due to leakage in the delivery system following repackaging. No illnesses have been reported.
Product
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0249-2025·2025-03-12
Morphine Sulfate Tablets Recalled Over Failed Dissolution Specifications
Sun Pharmaceutical is recalling Morphine Sulfate Extended-Release 100 mg tablets (lot AD16615) because they fail dissolution specifications, potentially resulting in unpredictable drug delivery.
Product
MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0253-2025·2025-03-12
Lorazepam Oral Syringes Recalled Due to Defective Delivery System Causing Leakage
Safecor Health, LLC is recalling Lorazepam 0.5 mg oral syringes nationwide due to a defective delivery system that causes leakage after repackaging.
Product
Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0255-2025·2025-03-12
Prescription Nelarabine Injection Recalled for Failed Purity and Degradation Specifications
Zydus Pharmaceuticals is recalling nationwide lots of Nelarabine Injection, a cancer medication, due to failed purity and degradation specifications. The affected vials did not meet required quality standards.
Product
NELARABINE — NELARABINE (NELARABINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0252-2025·2025-03-12
Ferrous Sulfate Oral Syringes Recalled Due to Leakage Defect
Safecor Health is recalling 1535 Ferrous Sulfate 7.5 mg oral syringes distributed nationwide due to leakage observed during repackaging. The defective delivery system could result in improper dosing of the iron supplement.
Product
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 69618007059.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0256-2025·2025-03-12
Nelarabine prescription injection recalled due to failed quality specifications
Zydus Pharmaceuticals is recalling 1,893 vials of Nelarabine Injection (250 mg/50 mL) due to failed quality specifications for impurities and degradation. Patients should contact their healthcare provider about the recall.
Product
NELARABINE — NELARABINE (NELARABINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0246-2025·2025-03-05
Estradiol Gel Recalled Nationwide for Defective Packet Sealing
Padagis US LLC recalls Estradiol Gel 0.1% nationwide due to defective packets that may not be fully sealed, potentially allowing ethanol loss.
Product
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0248-2025·2025-03-05
Avastin intravitreal injection syringes recalled for sterility assurance failure
Turbare Manufacturing recalls 1,147 syringes of Avastin 1.25 mg intravitreal injection nationwide due to a quality control process deviation affecting sterility assurance.
Product
Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0230-2025·2025-02-26
Phenylephrine HCl Injection Recall Due to Particulate Matter
Provepharm Inc. is recalling Phenylephrine HCl Injection vials (Lot 24020027) due to the presence of particulate matter. The affected medication was distributed nationwide.
Product
Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0245-2025·2025-02-26
Fentanyl Transdermal Patches Recalled for Defective Delivery System
Alvogen has recalled Fentanyl Transdermal System patches (25 mcg/h) nationwide due to a manufacturing defect where patches may be stacked together in a single pouch. Patients using affected lots should contact their healthcare provider.
Product
FENTANYL SYSTEM — FENTANYL SYSTEM (FENTANYL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0242-2025·2025-02-26
Atomoxetine Capsules Recalled for Manufacturing Impurity Above Limits
Glenmark Pharmaceuticals is recalling Atomoxetine Capsules, 60 mg due to N-Nitroso Atomoxetine impurity above FDA-recommended limits. Approximately 53,952 bottles were distributed nationwide.
Product
ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0236-2025·2025-02-26
Atomoxetine 80 mg Capsules Recalled for N-Nitroso Impurity Contamination
Glenmark Pharmaceuticals is recalling 87,600 bottles of Atomoxetine 80 mg capsules nationwide due to N-Nitroso Atomoxetine impurity detected above FDA-recommended limits. Consult your healthcare provider if affected.
Product
ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0239-2025·2025-02-26
Atomoxetine Capsules Recalled Nationwide for N-Nitroso Impurity Exceeding FDA Limits
Glenmark Pharmaceuticals is recalling 119,040 bottles of Atomoxetine Capsules nationwide due to N-Nitroso Atomoxetine Impurity exceeding FDA recommended limits.
Product
ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0241-2025·2025-02-26
Atomoxetine 40 mg Capsules Recalled for N-Nitroso Impurity Above Limits
Glenmark Pharmaceuticals is recalling 233,040 bottles of Atomoxetine 40 mg capsules nationwide due to N-Nitroso impurity above FDA safety limits. Patients should check their medication bottles and contact their healthcare provider.
Product
ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0233-2025·2025-02-26
Prescription Atomoxetine capsules recalled for N-Nitroso impurity
Glenmark Pharmaceuticals is recalling Atomoxetine 25 mg capsules nationwide due to the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits. Approximately 175,920 bottles are affected.
Product
ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
Category
Drug
Distribution
Distributed nationwide

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701–725 of 11803