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

1276–1300 of 18005

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-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-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-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
ModerateFDA (Drugs)·D-0250-2025·2025-03-12
Vitamin D Supplement Oral Syringes Recalled for Defective Delivery System
Safecor Health is recalling 3069 units of Ergocalciferol (Vitamin D Supplement) oral syringes nationwide due to leakage in the repackaged unit-dose delivery system. No illnesses have been reported.
Product
Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0251-2025·2025-03-12
Simethicone Oral Syringe Recalled for Defective Delivery System
Safecor Health is recalling Simethicone 20 mg oral syringes due to leakage caused by a defective delivery system. Approximately 10,992 syringes were distributed nationwide.
Product
Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.
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-0234-2025·2025-02-26
Atomoxetine capsules recalled due to elevated N-nitroso impurity
Glenmark Pharmaceuticals is recalling Atomoxetine 40 mg capsules nationwide due to manufacturing deviations. Some lots contain N-nitroso Atomoxetine impurity above FDA-recommended limits.
Product
ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0243-2025·2025-02-26
Atomoxetine Capsules Recalled Due to N-Nitroso Impurity Contamination
Glenmark Pharmaceuticals is recalling approximately 58,416 bottles of Atomoxetine 80 mg capsules nationwide due to the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits. This is a Class II recall.
Product
ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
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-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-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-0226-2025·2025-02-26
Lorazepam Tablets Recalled Due to Sub-Potency and Failed Stability Testing
The Harvard Drug Group is recalling Lorazepam Tablets USP 0.5mg due to sub-potency and failed stability test results. Approximately 82,281 cartons are affected nationwide and in Puerto Rico.
Product
LORAZEPAM — LORAZEPAM (LORAZEPAM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0235-2025·2025-02-26
Atomoxetine Capsules Recalled Due to Excess N-Nitroso Impurity
Glenmark Pharmaceuticals is recalling Atomoxetine capsules due to the presence of N-Nitroso Atomoxetine impurity above FDA recommended limits. The nationwide recall affects 80,160 bottles.
Product
ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0228-2025·2025-02-26
Lorazepam tablets recalled due to failed potency and impurity specifications
The Harvard Drug Group LLC is recalling Lorazepam 2mg tablets due to out-of-specification results in potency and impurity testing. Affected products were distributed nationwide.
Product
LORAZEPAM — LORAZEPAM (LORAZEPAM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0227-2025·2025-02-26
Lorazepam Tablets Recalled for Failed Impurity and Potency Specifications
The FDA is recalling 94,349 cartons of Lorazepam 1mg tablets due to out-of-specification results for impurities and sub-potency discovered during routine stability testing. The affected product was distributed nationwide in the U.S. and Puerto Rico.
Product
LORAZEPAM — LORAZEPAM (LORAZEPAM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0232-2025·2025-02-26
Atomoxetine Capsules Recalled for N-Nitroso Impurity Above FDA Limits
Glenmark Pharmaceuticals is recalling Atomoxetine capsules due to N-Nitroso impurity levels exceeding FDA recommended limits. The recall affects 56,208 bottles nationwide with specific lot numbers.
Product
ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0237-2025·2025-02-26
Atomoxetine Capsules Nationwide Recall for N-Nitroso Impurity Above FDA Limits
Glenmark Pharmaceuticals is recalling 39,168 bottles of Atomoxetine 100 mg capsules nationwide due to manufacturing deviations that resulted in N-Nitroso impurity exceeding FDA recommended limits. No illnesses have been reported.
Product
ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0240-2025·2025-02-26
Prescription Drug Recall: Atomoxetine Capsules Due to Impurity
Glenmark Pharmaceuticals is recalling Atomoxetine 25mg capsules nationwide due to manufacturing deviations resulting in N-Nitroso Atomoxetine impurity above FDA limits. Consumers should contact their healthcare provider or pharmacist.
Product
ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0225-2025·2025-02-26
FDA Recalls Compounded Fentanyl Citrate IV Bags Due to Sterility Concerns
Fagron Compounding Services is recalling 1,330 units of fentanyl Citrate IV bags (Lot C274-000040409) distributed in Pennsylvania due to lack of sterility assurance. The product may pose a contamination risk if administered.
Product
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
Category
Drug
Distribution
1 state

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1276–1300 of 18005