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

326–350 of 674

SevereFDA (Drugs)·D-0643-2022·2022-02-23
Paragard T380A Intrauterine Contraceptive Device Recall for Non-Sterility
CooperSurgical, Inc is recalling 48,645 cartons of Paragard T380A intrauterine contraceptive devices nationwide due to non-sterility concerns. The voluntary recall affects Lot #517001 with expiration date 1/2024.
Product
PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 51
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0563-2022·2022-02-23
MAC DADDY PURPLE Capsules Recalled for Undeclared Drug Ingredients
ABC Sales 1 Inc is recalling MAC DADDY PURPLE Capsules because they contain undeclared tadalafil and/or sildenafil, active ingredients in FDA-approved prescription drugs, making the product an unapproved drug.
Product
MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 605764.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0634-2022·2022-02-23
Morphine Sulfate Syringe Recall Due to Labeling Mix-Up
STAQ Pharma is recalling a limited number of syringes labeled as Morphine Sulfate PF that actually contain HYDROmorphone HCl PF due to a labeling error. The affected lot was distributed to Colorado, Ohio, and Texas.
Product
Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0105-04.
Category
Drug
Distribution
3 states
SevereFDA (Drugs)·D-0633-2022·2022-02-23
HYDROmorphone HCl syringe recalled due to labeling mix-up
STAQ Pharma is recalling HYDROmorphone HCl PF syringes (lot 21104221A) that were incorrectly labeled as Morphine Sulfate PF. The mislabeling affects approximately 905 syringes distributed in Colorado, Ohio, and Texas.
Product
HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0104-05.
Category
Drug
Distribution
3 states
SevereFDA (Drugs)·D-0562-2022·2022-02-23
MAC DADDY RED Capsules Recalled for Undeclared Drug Ingredients
MAC DADDY RED Capsules are being recalled because they contain undeclared tadalafil and/or sildenafil without FDA approval. The product was distributed nationwide via Amazon Marketplace.
Product
MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0638-2022·2022-02-23
RED MAMMOTH 400 mg Capsules Recalled for Undeclared Active Pharmaceutical Ingredients
RED MAMMOTH capsules, 400 mg (Lot # DK1027, Exp. 08/01/2023) are being recalled because they contain undeclared sildenafil and tadalafil, making them an unapproved drug marketed without FDA authorization.
Product
RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0557-2022·2022-02-16
MegMan Performance Booster capsules recalled for undeclared tadalafil
Junp Hydration LLC is recalling MegMan Performance Booster 800 mg capsules because the product contains undeclared tadalafil, an active pharmaceutical ingredient not listed on the label, making it an unapproved drug.
Product
MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, ASIN B08Z74KS88
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0556-2022·2022-02-16
Polymyxin B for Injection Recalled Due to Particulate Matter Contamination
AuroMedics Pharma LLC is recalling Polymyxin B for Injection USP (Lot CPB200013) nationwide due to the presence of particulate matter, including hair, found in vials.
Product
POLYMYXIN B — POLYMYXIN B (POLYMYXIN B)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0561-2022·2022-02-16
HARD DAWN Rise and Shine Capsules Recalled for Undisclosed Tadalafil
HARD DAWN Rise and Shine capsules (500 mg) are being recalled because they contain tadalafil, an FDA-approved drug, without proper approval or labeling. The product was sold nationwide via Amazon.
Product
HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0463-2022·2022-02-09
Medroxyprogesterone Acetate Injection Recalled for Sterility Assurance
Ideal Specialty Apothecary is recalling Medroxyprogesterone Acetate Injection due to lack of assurance of sterility. The recall affects approximately 57,994 vials distributed nationwide.
Product
Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union, NJ 07083
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0422-2022·2022-02-02
Ophthalmic Solution Recalled for Lack of Sterility Assurance
Edge Pharma is recalling a combination ophthalmic solution (Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac) distributed nationwide due to lack of assurance of sterility. The product is used for topical eye application.
Product
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-0859-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0411-2022·2022-02-02
Neostigmine Methylsulfate Injectable Syringes Recalled for Sterility Assurance
Edge Pharma, LLC is recalling Neostigmine methylsulfate 5 mg/5mL single-use syringes for IV or IM injection due to lack of assurance of sterility. Approximately 160 syringes nationwide may be affected.
Product
Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1549-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0421-2022·2022-02-02
Sterile Ophthalmic Solution Lacks Assurance of Sterility
Edge Pharma is recalling a sterile ophthalmic solution due to lack of assurance of sterility. The recall affects 2,562 syringes distributed nationwide.
Product
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0450-2022·2022-02-02
Pioglitazone Tablets Recalled for Superpotent and Failed Specifications
Aurobindo Pharma USA Inc. is recalling 792 bottles of Pioglitazone 45 mg tablets distributed nationwide due to superpotent tablets and tablets that fail to meet specifications.
Product
PIOGLITAZONE — PIOGLITAZONE (PIOGLITAZONE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0410-2022·2022-02-02
Moxifloxacin Ophthalmic Injection Syringes Recalled for Sterility Risk
Edge Pharma is recalling Moxifloxacin sterile ophthalmic injection syringes nationwide due to lack of assurance of sterility. The 860 affected syringes were distributed across two lots.
Product
Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LL, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1050-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0424-2022·2022-02-02
Vancomycin HCl Ophthalmic Solution Recalled for Sterility Assurance
Edge Pharma LLC is recalling Vancomycin HCl sterile ophthalmic solution for injection due to lack of assurance of sterility. The affected product was distributed nationwide.
Product
Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0736-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0407-2022·2022-02-02
Mitomycin-C Injectable Syringes Recalled for Sterility Assurance Failure
Edge Pharma is recalling Mitomycin-C 40 mg/40 mL single-dose syringes (NDC 05446-1416-01) nationwide due to lack of assurance of sterility. Approximately 860 syringes are affected.
Product
Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0415-2022·2022-02-02
Edge Pharma Phenylephrine HCl Syringes Recalled for Sterility Assurance
Edge Pharma, LLC is recalling Phenylephrine HCl 0.5 mg/5mL single-use syringes for intravenous injection nationwide due to lack of assurance of sterility. The affected product was distributed between September 2021 and January 2022.
Product
Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0392-2022·2022-02-02
Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Contamination
Viona Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release 750 mg tablets due to detection of N-Nitrosodimethylamine (NDMA) at levels exceeding the acceptable daily intake limit. The contamination resulted from manufacturing deviations.
Product
METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0398-2022·2022-02-02
Cefuroxime Sterile Ophthalmic Injection Recalled Due to Sterility Concerns
Edge Pharma is recalling Cefuroxime sterile ophthalmic solution for injection because the company cannot assure the product meets sterility requirements. The recall affects approximately 1,720 syringes distributed nationwide.
Product
Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446 NDC 05446-1003-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0425-2022·2022-02-02
Vancomycin HCl Injection Recall for Lack of Sterility Assurance
Edge Pharma, LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The 1,250 mg/250 mL pre-filled bags were distributed nationwide and may pose a safety risk if used.
Product
Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free), 250 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1456-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0399-2022·2022-02-02
Dexamethasone Sodium Phosphate Otic Injection Syringes Recalled for Lack of Sterility Assurance
Edge Pharma LLC is recalling Dexamethasone sodium phosphate sterile otic solution for injection syringes (NDC 05446-0848-01) due to lack of assurance of sterility. Approximately 323 syringes were distributed nationwide.
Product
Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe For Otic Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0848-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0402-2022·2022-02-02
Epinephrine/Lidocaine Ophthalmic Injection Syringe Recall for Sterility Assurance
Edge Pharma is recalling Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection due to lack of assurance of sterility. The recall affects 2,568 single-use syringes distributed nationwide.
Product
Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0426-2022·2022-02-02
Vancomycin HCl Injection Recalled for Sterility Assurance Issues
Edge Pharma LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The affected product is a 500 mL pre-filled bag for IV injection.
Product
Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1458-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0418-2022·2022-02-02
Phenylephrine Injection Recall Due to Sterility Assurance Concerns
Edge Pharma is recalling phenylephrine injection (20 mg/250 mL) because the manufacturer cannot assure the product maintains sterility. The recall affects 3,930 bags distributed nationwide.
Product
PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT NDC 05446-1667-01
Category
Drug
Distribution
Distributed nationwide

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326–350 of 674