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

4901–4925 of 11852

SevereFDA (Drugs)·D-1269-2019·2019-05-08
Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity
Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because FDA labs found an impurity above acceptable levels.
Product
Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1251-2019·2019-05-08
Advanced Pharma Recalls Sub-Potent Hydromorphone Injectable Solution
Advanced Pharma Inc. is voluntarily recalling 560 bags of compounded Hydromorphone 20 mg/100 mL Injectable Solution due to sub-potency. The product was distributed nationwide in the US.
Product
HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded Drug, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC: 42852-221-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1216-2019·2019-05-01
Magnesium Sulfate IV Bags Recalled Due to Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 196 bags of Magnesium Sulfate 6 GM in NS 50 mL due to a lack of sterility assurance. The product was distributed in North Carolina.
Product
Magnesium Sulfate 6 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1221-2019·2019-05-01
CMC Enterprise Pharmacy Recalls Lidocaine Syringes Due to Sterility Concerns
CMC Enterprise Pharmacy is recalling 705 syringes of Lidocaine Buffered with J-Tip due to a lack of sterility assurance. The products were distributed in North Carolina.
Product
Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1225-2019·2019-05-01
CMC Enterprise Pharmacy Recalls CeFAZolin Due to Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling specific lots of CeFAZolin 2 GM in bags and syringes due to a lack of sterility assurance. The products were distributed in North Carolina.
Product
CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1220-2019·2019-05-01
Alteplase Syringes Recalled Due to Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 97 syringes of Alteplase 1 mg/mL due to a lack of sterility assurance. The affected lots were distributed in North Carolina.
Product
Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1212-2019·2019-05-01
Labetalol Syringes Recalled for Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 6,667 Labetalol syringes due to a lack of sterility assurance. The affected products were distributed in North Carolina.
Product
Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1231-2019·2019-05-01
Phenylephrine IV Bags Recalled Due to Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 390 bags of Phenylephrine 20 mg NS 250 mL due to a lack of sterility assurance. The affected lots were distributed in North Carolina.
Product
Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1234-2019·2019-05-01
Sodium Citrate Syringes Recalled for Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 40 syringes of Sodium Citrate 4% due to a lack of sterility assurance. The affected lots were distributed in North Carolina.
Product
Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1230-2019·2019-05-01
Phenylephrine Syringes Recalled Due to Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 1,310 syringes of Phenylephrine 0.8 mg/10 mL NS due to a lack of sterility assurance. The affected lots were distributed in North Carolina.
Product
Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1214-2019·2019-05-01
CMC Enterprise Pharmacy Recalls Magnesium Sulfate Bags Due to Sterility Concerns
CMC Enterprise Pharmacy is recalling 6,746 bags of Magnesium Sulfate 2 GM in NS 50 mL due to a lack of sterility assurance. The affected products were distributed in North Carolina.
Product
Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1238-2019·2019-05-01
Vancomycin Bags Recalled Due to Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 118 bags of Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL due to lack of sterility assurance.
Product
Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1232-2019·2019-05-01
Phenylephrine IV Bags Recalled for Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 215 bags of Phenylephrine 40 mg in 0.9% Sodium Chloride due to a lack of sterility assurance. The product was distributed in North Carolina.
Product
Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1236-2019·2019-05-01
Vancomycin IV Bags Recalled Due to Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 737 bags of Vancomycin 1250 mg in NS 250 mL due to a lack of sterility assurance. The product was distributed in North Carolina.
Product
Vancomycin 1250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1223-2019·2019-05-01
CMC Enterprise Pharmacy Recalls Lidocaine Syringes Due to Sterility Concerns
CMC Enterprise Pharmacy is recalling Lidocaine 1% - Sodium Bicarbonate 8.4% syringes due to a lack of sterility assurance. The affected products were distributed in North Carolina.
Product
Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1233-2019·2019-05-01
Sodium Bicarbonate IV Bags Recalled for Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 100 bags of Sodium Bicarbonate 150 mEq in D5W 1000 mL due to lack of sterility assurance.
Product
Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1239-2019·2019-05-01
CMC Enterprise Pharmacy Recalls Vancomycin Bags Due to Sterility Concerns
CMC Enterprise Pharmacy is recalling 532 bags of Vancomycin 2000 mg in 0.9% Sodium Chloride due to a lack of sterility assurance.
Product
Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1215-2019·2019-05-01
CMC Enterprise Pharmacy Recalls Magnesium Sulfate Bags Due to Sterility Concerns
CMC Enterprise Pharmacy is recalling 3,007 bags of Magnesium Sulfate 4 GM in NS 50 mL due to a lack of sterility assurance. The affected lots were distributed in North Carolina.
Product
Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1237-2019·2019-05-01
Vancomycin 1500 mg Bags Recalled Due to Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 715 bags of Vancomycin 1500 mg in NS 250 mL due to a lack of sterility assurance. The product was distributed in North Carolina.
Product
Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1209-2019·2019-05-01
Dexmedetomidine Bags Recalled for Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 5,678 bags of Dexmedetomidine 400 mcg in NS 100 mL due to a lack of sterility assurance. The affected products were distributed in North Carolina.
Product
Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1224-2019·2019-05-01
CMC Enterprise Pharmacy Recalls CeFAZolin Due to Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling CeFAZolin 1 GM products in North Carolina due to a lack of sterility assurance.
Product
CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1219-2019·2019-05-01
CMC Enterprise Pharmacy Recalls Oxytocin Bags Due to Sterility Concerns
CMC Enterprise Pharmacy is recalling 3,690 bags of Oxytocin 30 units in NS 500 mL due to a lack of sterility assurance. The product was distributed in North Carolina.
Product
Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1235-2019·2019-05-01
CMC Enterprise Pharmacy Recalls Vancomycin Bags Due to Sterility Concerns
CMC Enterprise Pharmacy is recalling 532 bags of Vancomycin 1000 mg in NS 250 mL due to a lack of sterility assurance. The affected lots were distributed in North Carolina.
Product
Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1211-2019·2019-05-01
Diltiazem 250 mg IV Bags Recalled for Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 1,475 bags of Diltiazem 250 mg in NS 250 mL due to a lack of sterility assurance. The product was distributed in North Carolina.
Product
Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1213-2019·2019-05-01
CMC Enterprise Pharmacy Recalls Magnesium Sulfate Bags Due to Sterility Concerns
CMC Enterprise Pharmacy is recalling 2,162 bags of Magnesium Sulfate 1 GM in NS 50 mL due to a lack of sterility assurance. The affected products were distributed in North Carolina.
Product
Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Category
Drug
Distribution
1 state

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4901–4925 of 11852