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

2701–2725 of 11852

HighFDA (Drugs)·D-0908-2022·2022-06-01
Sodium Tetradecyl Sulfate Injection Recalled for Lack of Sterility Assurance
Olympia Pharmacy is recalling 588 vials of Sodium Tetradecyl Sulfate 5% injection nationwide due to inability to assure product sterility. The multi-dose vials carry a potential contamination risk for patients.
Product
Sodium Tetradecyl Sulfate 5% MDV Injection, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0102-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0917-2022·2022-06-01
Alpha Lipoic Acid injection vials recalled for sterility assurance defect
Olympia Compounding Pharmacy is recalling 3,286 vials of Alpha Lipoic Acid 25 mg/mL due to inability to assure sterility. Patients should contact their healthcare provider to verify their medication and discuss alternatives.
Product
Alpha Lipoic Acid 25 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0076-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0894-2022·2022-06-01
Blood Pressure Medication Recalled for Manufacturing Impurity
Direct Rx is recalling batches of Losartan Potassium/Hydrochlorothiazide tablets due to CGMP deviations with elevated AZIDO impurity levels. The affected product was distributed in Florida.
Product
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0946-2022·2022-06-01
Pyridoxine Injection Vials Recalled Due to Sterility Concerns
Olympia Compounding Pharmacy is recalling 1,306 vials of Pyridoxine HCL 100 mg/mL injection due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Product
Pyridoxine HCL 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0066-30.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0928-2022·2022-06-01
Formula F2 Compounded Injectable Medication Recalled for Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Formula F2, a multi-ingredient injectable medication, because the manufacturer cannot assure sterility. The recall affects 72 vials distributed nationwide.
Product
Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atropine 0.1 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0002-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0907-2022·2022-06-01
FDA Recalls Sodium Tetradecyl Sulfate Injectable Over Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Sodium Tetradecyl Sulfate 1.5% Injection (480 vials, Lot B24308-22) due to lack of assurance of sterility. The injectable was distributed nationwide.
Product
Sodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0122-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0915-2022·2022-06-01
Vitamin D3 Injectable Recalled Due to Sterility Assurance Issues
Olympia Compounding Pharmacy is recalling Vitamin D3 injectable vials due to lack of sterility assurance. A total of 3,083 vials were distributed nationwide.
Product
Vitamin D3 (50,000 IU/mL)Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0075-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0932-2022·2022-06-01
Lipo-Mino-Mix Injectable Compounded Drug Recalled for Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Lipo-Mino-Mix injectable vitamins nationwide due to manufacturing failure to ensure product sterility. No illnesses have been reported.
Product
Lipo-Mino-Mix Pyridoxine HCL (B6) 2 mg/mL Methionine 12.4 mg/mL Inositol 25 mg/mL Choline Chloride 25 mg/mL Thiamine HCL (B1) 50 mg/mL Riboflavin5P04 (B2) 5 mg/mL, Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0130-10; b) 30 mL Multi-Dose vial, NDC 73198-0130-30; Rx Only, Olymp
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0931-2022·2022-06-01
Lidocaine-Epinephrine Injectable Vials Recalled for Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Lidocaine 1%/Epinephrine 1:100,000 injection vials due to lack of sterility assurance. The recall affects 310 vials distributed nationwide.
Product
Lidocaine 1%/Epinephrine 1:100,000/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0099-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0900-2022·2022-06-01
Compounded Injectable Drug Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling SB-5, a multi-dose injectable medication, due to lack of assurance of sterility. The product was distributed nationwide; patients should contact their healthcare provider immediately.
Product
SB-5 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 50 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0024-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0929-2022·2022-06-01
Compounded Injectable Medication Recalled Due to Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling 205 vials of Formula F9 injectable medication nationwide due to lack of assurance of sterility. The FDA has classified this as a Class II recall.
Product
Formula F9 Papaverine 0.9 mg/mL Phentolamine 0.1 mg/mL PGE 20 mcg/mL Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0004-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0925-2022·2022-06-01
FDA Recalls Compounded Injectable for Lack of Sterility Assurance
Olympia Compounding Pharmacy recalls a multi-drug injectable compound (lot B41C22-22) due to inability to assure sterility. The recall affects 1,159 vials distributed nationwide.
Product
FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil 20 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, 6700 Olympia Pharmaceuticals, Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0006-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0904-2022·2022-06-01
Sodium Bicarbonate 8.4% Injectable Recalled Over Sterility Assurance Concerns
Olympia Compounding Pharmacy is recalling 1,466 vials of Sodium Bicarbonate 8.4% Multi-Dose Injectable (Lot L41002) due to lack of assurance of sterility. The product was distributed nationwide.
Product
Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0101-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0940-2022·2022-06-01
Injectable pharmaceutical vial recalled due to sterility assurance failure
Olympia Compounding Pharmacy is recalling an injectable medication vial due to lack of sterility assurance. The recall affects 606 vials distributed nationwide, Puerto Rico, and US Virgin Islands.
Product
NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0010-10.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0920-2022·2022-06-01
Bimix-3 Injectables Recalled for Lack of Sterility Assurance
Bimix-3 compounded injectable (1,287 vials) recalled nationwide due to lack of sterility assurance. Patients should consult their healthcare provider about whether they received affected product.
Product
Bimix-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL, Packaged as a) 2.5 mL Multi-Dose Vial, NDC73198-0027-03; b) 10 mL Multi-Dose Vial, NDC 73198-0027-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0924-2022·2022-06-01
Dexpanthenol 250 mg/mL Injectable Solution Recalled for Sterility Failure
Olympia Compounding Pharmacy is recalling 1,296 vials of Dexpanthenol 250 mg/mL injectable solution distributed nationwide due to lack of assurance of sterility in the manufacturing process.
Product
Dexpanthenol 250 mg/mL Multi-Dose 30 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0070-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0897-2022·2022-06-01
QM-4 Compounded Injectable Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy recalls QM-4, a multi-drug compounded injectable, due to lack of assured sterility. 914 vials distributed nationwide in the USA, Puerto Rico, and US Virgin Islands are affected.
Product
QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0020-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0923-2022·2022-06-01
Pyridoxine Injection Vials Recalled by FDA Due to Sterility Failure
Olympia Compounding Pharmacy is recalling 1,306 vials of Pyridoxine 100 mg/mL injectable due to lack of assurance of sterility. The multi-dose vials were distributed nationwide and may pose infection risk if administered.
Product
Pyridoxine 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0066-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0926-2022·2022-06-01
Injectable Folic Acid and Hydroxocobalamin Recalled Due to Sterility Concerns
Olympia Compounding Pharmacy is recalling 2,441 vials of Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL injectable due to lack of sterility assurance. The affected vials were distributed nationwide, in Puerto Rico, and the US Virgin Islands.
Product
Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0112-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0885-2022·2022-06-01
Losartan HCTZ Medication Recalled for Elevated AZIDO Impurity
RemedyRepack Inc. is recalling Losartan HCTZ 50/12.5 mg tablets due to elevated AZIDO impurity levels exceeding acceptable manufacturing standards. The recalled product was distributed to Florida.
Product
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0899-2022·2022-06-01
Compounded Injectable Medication Recalled Due to Sterility Assurance Concerns
Olympia Compounding Pharmacy recalled 1,710 vials of RE-2 injectable medication due to lack of assurance of sterility. Affected vials were distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
Product
RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0016-03; b) 10 mL Multi Dose vial, NDC 73198-0016-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0934-2022·2022-06-01
Injectable drug recalled for lack of sterility assurance
Olympia Compounding Pharmacy is recalling injectable Lipostat Plus SF vials due to inability to assure sterility. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Product
Lipostat Plus SF Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1 mg/mL Pyridoxine HCL 175 mcg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0048-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0937-2022·2022-06-01
MICC Injectable Drug Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling 5,334 vials of MICC injectable due to lack of sterility assurance. Distribution was nationwide in the USA, Puerto Rico, and US Virgin Islands.
Product
MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanobalamin 330 mcg/mL, Packaged as a) Multi-Dose 10 mL vial, NDC 73198-0052-10; b) Multi-Dose 30 mL vial, NDC 73198-0052-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0942-2022·2022-06-01
FDA Recalls Olympia Vita-Complex Injection Due to Sterility Concerns
Olympia Compounding Pharmacy has recalled 8,664 vials of Olympia Vita-Complex B-vitamin injection nationwide due to lack of assurance of sterility. The affected multi-dose vials may pose an infection risk to patients who receive the product.
Product
Olympia Vita-Complex Thiamine HCL (B1) 100 mg/mL Niacinamide (B3) 100 mg/mL Riboflavin 5 P04 (B2) 2 mg/mL Dexpanthenol (B5) 2 mg/mL Pyridoxine HCL (B6) 2 mg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0063-30.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0901-2022·2022-06-01
Olympia Compounding Pharmacy Recalls Papaverine-Phentolamine Injectable Due to Sterility Concerns
Olympia Compounding Pharmacy is recalling SB-6, a compounded injectable medication, due to lack of assurance of sterility. The recall affects 874 vials distributed nationwide, in Puerto Rico, and the US Virgin Islands.
Product
SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Category
Drug
Distribution
Distributed nationwide

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2701–2725 of 11852