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

2676–2700 of 11852

HighFDA (Drugs)·D-0957-2022·2022-06-08
Hydromorphone Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Hydromorphone HCl Injection 50 mg/50 mL pre-filled syringes due to lack of sterility assurance. The recalled product was distributed nationwide.
Product
Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe, 5 x 50 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0959-2022·2022-06-08
Ketamine Hydrochloride Injectable Recalled Due to Sterility Assurance Issues
Nephron Sterile Compounding Center LLC is recalling 30,290 syringes of Ketamine Hydrochloride Injection due to lack of assurance of sterility. The injectable drug was distributed nationwide.
Product
Ketamine Hydrochloride Injection, USP, 30 mg/3 mL (10 mg/mL), 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-33
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0974-2022·2022-06-08
Losartan Potassium Tablets Recalled for CGMP Deviations and Elevated Impurity
Strides Pharma Inc. is recalling Losartan Potassium 100 mg tablets nationwide due to CGMP deviations with AZIDO impurity levels above acceptable limits. Patients should contact their healthcare provider to verify if they are affected.
Product
LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0955-2022·2022-06-08
Glycopyrrolate Injection Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center recalls glycopyrrolate injection (1 mg/5 mL, preservative-free) due to lack of assurance of sterility. Approximately 32,550 pre-filled syringes from lot GL2002B have been distributed nationwide.
Product
Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0966-2022·2022-06-08
Phenylephrine HCl Injection recalled for lack of sterility assurance
Nephron Sterile Compounding Center is recalling Phenylephrine HCl Injection syringes nationwide due to lack of assurance of sterility affecting 76,860 units.
Product
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1124-2022·2022-06-01
Benzonatate 100mg Capsules Label Mix-up — Wrong Medication in Bottles
Benzonatate 100mg capsule bottles are mislabeled. Some contain Benzphetamine tablets instead, and vice versa. This medication mix-up affects 10 bottles distributed to one physician in Alpharetta, Georgia.
Product
Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 67877-0573-05
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0945-2022·2022-06-01
FDA Recalls Phenylephrine 1 mg/mL Vials for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling 9,102 vials of Phenylephrine 1 mg/mL due to lack of assurance of sterility. The affected vials were distributed nationwide in the United States, Puerto Rico, and US Virgin Islands.
Product
Phenylephrine 1 mg/mL, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0021-05.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0944-2022·2022-06-01
FDA Recalls Olympia Alprostadil 150 mcg/mL Injectable Vials for Sterility Concerns
Olympia Compounding Pharmacy is recalling PGE-3 Alprostadil 150 mcg/mL multi-dose injectable vials nationwide due to lack of assurance of sterility. The recall involves 421 vials from lot L24508.
Product
PGE-3 Alprostadil 150 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0030-10.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0898-2022·2022-06-01
RE-1 Compounded Injectable Medication Recalled Due to Sterility Assurance Issues
Olympia Compounding Pharmacy is recalling 482 vials of RE-1 (Papaverine, Phentolamine, Alprostadil) injectable medication due to lack of sterility assurance. Product was distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
Product
RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0015-03; b) 10 mL Multi Dose vial, NDC 73198-0015-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0918-2022·2022-06-01
Preserved ascorbic acid recalled due to lack of sterility assurance
Olympia Compounding Pharmacy is recalling 7,420 vials of Preserved Ascorbic Acid due to lack of assurance of sterility. The injectable drug was distributed nationwide throughout the USA, Puerto Rico, and US Virgin Islands.
Product
Preserved Ascorbic Acid 500 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0079-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0893-2022·2022-06-01
Losartan Potassium and Hydrochlorothiazide Recall: Impurity Levels Above Acceptable Limits
Direct Rx is recalling Losartan Potassium and Hydrochlorothiazide tablets due to azido impurity levels above acceptable limits resulting from manufacturing deviations. Patients should consult their healthcare provider regarding their medication.
Product
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0919-2022·2022-06-01
Compounded Injectable Drug Recalled Due to Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling AT-6, a compounded injectable medication, due to lack of sterility assurance. The recall affects 528 vials from Lot K24409.
Product
AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0.3 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0040-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0936-2022·2022-06-01
Methylcobalamin Injectable Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy recalls Methylcobalamin 5 mg/mL injectable due to lack of assurance of sterility. Approximately 12,800 vials were distributed nationwide.
Product
Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose 10mL vial, NDC 73198-0051-10; b) Multi-Dose 30mL vial, NDC 73198-0051-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0935-2022·2022-06-01
Magnesium Chloride injection recalled due to lack of sterility assurance
Olympia Compounding Pharmacy is recalling 1,597 vials of Magnesium Chloride injection due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
Product
Magnesium Chloride, 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0072-30.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0922-2022·2022-06-01
Cyanocobalamin Injectable Vials Recalled Due to Lack of Sterility Assurance
Olympia Compounding Pharmacy recalls 1282 vials of Cyanocobalamin 2 mg/mL due to lack of sterility assurance. The affected vials were distributed nationwide in the United States, Puerto Rico, and US Virgin Islands.
Product
Cyanocobalamin 2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0115-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0902-2022·2022-06-01
Sermorelin Acetate Injection Recalled Due to Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Sermorelin Acetate injectable powder because of insufficient assurance of sterility. Patients using affected lots should contact their healthcare provider.
Product
Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0059-00
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0892-2022·2022-06-01
Losartan Potassium and HCTZ Tablets Recalled for AZIDO Impurity Deviations
Preferred Pharmaceuticals is recalling specific lots of Losartan Potassium & HCTZ Tablets due to AZIDO impurity levels exceeding acceptable manufacturing standards. The recalled tablets were distributed in Florida and California.
Product
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0910-2022·2022-06-01
Injectable T-106 Vials Recalled Due to Sterility Assurance Deficiency
Olympia Compounding Pharmacy recalls T-106 injectable vials due to lack of sterility assurance. The affected vials were distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
Product
T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL, Packaged as a) 5 mL Multi-Dose vial NDC 73198-0013-05; b) 10 mL Multi-Dose vial NDC 73198-0013-10, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0905-2022·2022-06-01
Sodium Selenite Injectable Vials Recalled for Sterility Assurance Failure
Olympia Compounding Pharmacy recalls 2,333 vials of Sodium Selenite 200 mg/mL injection due to a lack of assurance of sterility. The product was distributed nationwide in the USA, Puerto Rico, and the U.S. Virgin Islands.
Product
Sodium Selenite 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0074-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0947-2022·2022-06-01
Compounded Injectable Medication Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling QM-2, a compounded multi-dose injectable medication, because the manufacturer cannot assure the product's sterility. The recall affects 619 vials distributed nationwide.
Product
QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine 0.2 mg/mL Multi-Dose 10 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0018-10.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0886-2022·2022-06-01
Losartan HCTZ drug recall due to azido impurity levels above limits
RemedyRepack Inc. is recalling Losartan HCTZ 100/25 mg tablets distributed in Florida, South Carolina, and Virginia due to azido impurity levels exceeding acceptable manufacturing limits.
Product
Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
Category
Drug
Distribution
3 states
HighFDA (Drugs)·D-0906-2022·2022-06-01
FDA Recalls Sodium Tetradecyl Sulfate Injection Due to Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Sodium Tetradecyl Sulfate 0.3% Injection due to lack of sterilization assurance. The 943 vials of this injectable product were distributed nationwide and may not meet sterile manufacturing requirements.
Product
Sodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0121-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0903-2022·2022-06-01
Pharmaceutical Diluent Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling pharmaceutical diluent vials due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Product
Diluent for Reconstitution Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0113-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0889-2022·2022-06-01
Prescription Drug Daytrana Patches Recalled for Defective Delivery System
Noven Pharmaceuticals is recalling Daytrana methylphenidate transdermal patches from Lot 90764 (expiration 08/2022) distributed nationwide due to defects in the delivery system. The recall was initiated after customer complaints exceeded FDA action limits.
Product
DAYTRANA — DAYTRANA (METHYLPHENIDATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0938-2022·2022-06-01
Myers Cocktail Injectable Vials Recalled for Sterility Assurance Issues
Olympia Compounding Pharmacy is recalling Myers Cocktail injectable vials due to lack of assurance of sterility. The recall affects approximately 13,679 vials distributed nationwide.
Product
Myers Cocktail, Magnesium Chloride 9.65 mg/mL Dexpanthenol 4.07 mg/mL Thiamine HCL 1.62 mg/mL Riboflavin-5-Phosphate 3.23 mg/mL Pyridoxine HCL 1.63 mg/mL Niacinamide 1.62 mg/mL Calcium Gluconate 4.07 mg/mL Ascorbic Acid 64.4 mg/mL, Single-Dose 10 mL vial, Rx Only, Olympia Pharmac
Category
Drug
Distribution
Distributed nationwide

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2676–2700 of 11852