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

551–575 of 11803

HighFDA (Drugs)·D-0560-2025·2025-08-13
Compounded tirzepatide 16.6 mg vials recalled over lack of processing controls
Tirzepatide + Niacinamide 16.6 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 155 vials are affected.
Product
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0561-2025·2025-08-13
Compounded semaglutide 0.44 mg vials recalled over lack of processing controls
Semaglutide + Cyanocobalamin 0.44 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 221 vials are affected.
Product
Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0558-2025·2025-08-13
Compounded tirzepatide 11.24 mg vials recalled over lack of processing controls
Tirzepatide + Niacinamide 11.24 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 146 vials are affected.
Product
Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0568-2025·2025-08-13
Direct Rx duloxetine 30 mg capsules exceed the interim nitrosamine limit
Duloxetine Delayed-Release 30 mg capsules packaged by Direct Rx are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 875 bottles affected.
Product
Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0557-2025·2025-08-13
Compounded tirzepatide 8.8 mg vials recalled over lack of processing controls
Tirzepatide + Niacinamide 8.8 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 139 vials are affected.
Product
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0562-2025·2025-08-13
Compounded semaglutide and cyanocobalamin vials recalled over lack of processing controls
Semaglutide + Cyanocobalamin 0.88 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 194 vials are affected.
Product
Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0563-2025·2025-08-13
Compounded semaglutide 1.5 mg vials recalled over lack of processing controls
Semaglutide + Cyanocobalamin 1.5 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 190 vials are affected.
Product
Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0556-2025·2025-08-13
Compounded tirzepatide 6.6 mg vials recalled over lack of processing controls
Tirzepatide + Niacinamide 6.6 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 160 vials are affected.
Product
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0552-2025·2025-08-13
Duloxetine 60 mg capsules exceed the safety assessment limit for nitrosamine
Duloxetine Delayed-Release Capsules USP 60 mg distributed by Breckenridge are being recalled because N-nitroso-duloxetine was present above the safety assessment limit. 1,829 bottles affected.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0553-2025·2025-08-13
Compounded semaglutide 0.22 mg vials recalled over lack of processing controls
Semaglutide + Cyanocobalamin 0.22 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 290 vials are affected.
Product
Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0555-2025·2025-08-13
Compounded tirzepatide 4.4 mg vials recalled over lack of processing controls
Tirzepatide + Niacinamide 4.4 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 170 vials are affected.
Product
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0566-2025·2025-08-13
Doxepin hydrochloride capsules exceed the interim nitrosamine impurity limit
Doxepin Hydrochloride Capsules USP 10 mg from Alembic are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 9,492 bottles affected.
Product
DOXEPIN HYDROCHLORIDE — DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0559-2025·2025-08-13
Compounded tirzepatide 13.2 mg vials recalled over lack of processing controls
Tirzepatide + Niacinamide 13.2 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 143 vials are affected.
Product
Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0564-2025·2025-08-13
Compounded semaglutide 2.21 mg vials recalled over lack of processing controls
Semaglutide + Cyanocobalamin 2.21 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 176 vials are affected.
Product
Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0545-2025·2025-08-06
Bicillin L-A 2.4 million unit vials recalled after particulates found
Bicillin L-A (penicillin G benzathine injectable suspension) 2,400,000 units per 4 mL is being recalled because of CGMP deviations, with particulates identified during visual inspection. 19,279 vials affected.
Product
BICILLIN L-A — BICILLIN L-A (PENICILLIN G BENZATHINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0544-2025·2025-08-06
Bicillin L-A penicillin vials recalled after particulates found during visual inspection
Bicillin L-A (penicillin G benzathine injectable suspension) 1,200,000 units per 2 mL is being recalled because of CGMP deviations, with particulates identified during visual inspection. 50,855 vials affected.
Product
BICILLIN L-A — BICILLIN L-A (PENICILLIN G BENZATHINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0535-2025·2025-07-30
Compounded epinephrine lidocaine vials returned subpotent assay results in stability testing
Epinephrine Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL vials compounded by Imprimis NJOF are being recalled because of subpotent assay results during stability testing. 6,880 vials affected.
Product
Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0541-2025·2025-07-30
Budesonide inhalation ampoules recalled after leakage and empty ampoule complaint
Budesonide Inhalation Suspension 0.5 mg/2 mL is being recalled for lack of assurance of sterility after a market complaint was received for leakage and an empty ampoule. 13,680 ampoules affected.
Product
BUDESONIDE — BUDESONIDE (BUDESONIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0532-2025·2025-07-23
Lisinopril and hydrochlorothiazide bottle contained a foreign antiretroviral tablet
Lisinopril and Hydrochlorothiazide Tablets 20 mg/12.5 mg are being recalled after a complaint that a sealed bottle contained a foreign tablet identified as atazanavir and ritonavir. 58,968 bottles affected.
Product
LISINOPRIL AND HYDROCHLOROTHIAZIDE — LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0518-2025·2025-07-23
Levothyroxine sodium 25 microgram tablets assayed below the approved specification
Levothyroxine Sodium Tablets, USP 25 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 82,159 bottles affected.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0523-2025·2025-07-23
Levothyroxine sodium 150 microgram tablets assayed below the approved specification
Levothyroxine Sodium Tablets, USP 150 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 4,921 bottles affected.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0525-2025·2025-07-23
Omeprazole capsule bottle contained a foreign divalproex sodium tablet
Omeprazole Delayed-release Capsules USP 20 mg are being recalled because a foreign Divalproex Sodium Extended-Release 250 mg tablet was found in a bottle. 1,476 bottles affected.
Product
OMEPRAZOLE — OMEPRAZOLE (OMEPRAZOLE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0520-2025·2025-07-23
Levothyroxine sodium 50 microgram tablets assayed below the approved specification
Levothyroxine Sodium Tablets, USP 50 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 54,227 bottles affected.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0522-2025·2025-07-23
Levothyroxine sodium 112 microgram tablets assayed below the approved specification
Levothyroxine Sodium Tablets, USP 112 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 4,896 bottles affected.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0533-2025·2025-07-23
Rizatriptan 5 mg tablets exceed the acceptable intake limit for nitrosamine
Rizatriptan Benzoate Tablets USP 5 mg are being recalled after detection of N-nitroso-dimethyl-rizatriptan above the FDA recommended acceptable intake limit.
Product
RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
Category
Drug
Distribution
Distributed nationwide

How to read this listing

Filters

551–575 of 11803