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

4801–4825 of 11819

SevereFDA (Drugs)·D-1424-2019·2019-07-03
Premier Pharmacy Labs Recalls Phenylephrine Injection Due to Sterility Concerns
Premier Pharmacy Labs is recalling 1,040 syringes of Phenylephrine HCL injection nationwide because FDA inspections found insufficient environmental controls that may compromise sterility.
Product
Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*, 10mL Single-Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-236-16, barcode 8 69623 23616 2.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1415-2019·2019-07-03
Premier Pharmacy Labs Recalls Droperidol Syringes Due to Sterility Concerns
Premier Pharmacy Labs is recalling 2,315 syringes of Droperidol Injectable Sterile Solution because FDA inspections found insufficient environmental controls and lack of sterility assurance.
Product
Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-185-10, barcode 0 69623 18510 5.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1418-2019·2019-07-03
Premier Pharmacy Labs Recalls Isoproterenol HCL Bags Due to Sterility Concerns
Premier Pharmacy Labs is recalling 40 bags of Isoproterenol HCL in D5W due to FDA findings of insufficient environmental controls and lack of sterility assurance.
Product
Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-107-57, barcode 3 69623 10757 3.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1423-2019·2019-07-03
Premier Pharmacy Labs Recalls Orphenadrine Citrate Syringes Due to Sterility Concerns
Premier Pharmacy Labs is recalling 4,363 syringes of Orphenadrine Citrate Sterile Injectable Solution because FDA inspections found insufficient environmental controls that may compromise sterility.
Product
Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-104-10, barcode 7 69623 10410 5.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1426-2019·2019-07-03
Premier Pharmacy Labs Recalls Sodium Bicarbonate Injection Due to Sterility Concerns
Premier Pharmacy Labs is recalling 13,150 vials of Sodium Bicarbonate Injection 8.4% nationwide because FDA inspections found insufficient environmental controls and lack of sterility assurance.
Product
Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-232-39, barcode 8 69623 23239 3.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1416-2019·2019-07-03
Premier Pharmacy Labs Recalls Isoproterenol Bags Due to Sterility Concerns
Premier Pharmacy Labs is recalling 606 bags of Isoproterenol HCL in D5W because FDA inspections found insufficient environmental controls that may compromise sterility.
Product
Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-230-57, barcode 0 69623 23057 7.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1434-2019·2019-07-03
American Health Packaging Recalls Pramipexole Dihydrochloride Tablets Due to GMP Deviations
American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to GMP deviations and possible cross-contamination from cleaning failures.
Product
Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-982-95; NDC Carton: 68084-982-25
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1433-2019·2019-07-03
Pramipexole Dihydrochloride Tablets Recalled for GMP Deviations and Cross-Contamination Risk
American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to GMP deviations and a cleaning procedure failure that may have caused cross-contamination.
Product
Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-974-95; NDC Carton: 68084-974-25
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1422-2019·2019-07-03
Premier Pharmacy Labs Recalls Neostigmine Methylsulfate Syringes for Sterility Concerns
Premier Pharmacy Labs is recalling Neostigmine Methylsulfate syringes nationwide due to FDA findings of insufficient environmental controls and lack of sterility assurance.
Product
Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-234-15, barcode 5 69623 23415 0.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1429-2019·2019-07-03
Acetaminophen Children's Liquid Recalled for Microbial Contamination Risk
H J Harkins Company is recalling 40 bottles of Acetaminophen Children's Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1428-2019·2019-07-03
Premier Pharmacy Labs Recalls Succinylcholine Chloride Syringes for Sterility Concerns
Premier Pharmacy Labs is recalling 1,721 syringes of Succinylcholine Chloride due to FDA findings of insufficient environmental controls and lack of sterility assurance.
Product
SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-239-16, barcode 9 69623 23916 0.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1413-2019·2019-07-03
Premier Pharmacy Labs Recalls Chlorpromazine Injection Due to Sterility Concerns
Premier Pharmacy Labs is recalling 824 vials of Chlorpromazine HCL Injection because an FDA inspection found insufficient environmental controls that may compromise sterility.
Product
ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-122-28, barcode 7 69623 12228 4.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1412-2019·2019-07-03
Premier Pharmacy Labs Recalls Brilliant Blue Ophthalmic Injection for Sterility Concerns
Premier Pharmacy Labs is recalling 578 vials of Brilliant Blue Ophthalmic Injection due to a lack of assurance of sterility identified during an FDA inspection.
Product
Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-211-31, barcode 2 69623 21131 0.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1425-2019·2019-07-03
Premier Pharmacy Labs Recalls Riboflavin 5-Phosphate Sodium Ophthalmic Solution
Premier Pharmacy Labs is recalling 125 bottles of Riboflavin 5-Phosphate Sodium Ophthalmic Solution due to a lack of assurance of sterility.
Product
Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-106-61, barcode 1 69623 10661 9.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1430-2019·2019-07-03
Diphenhydramine Liquid Recalled for Potential Microbial Contamination
H J Harkins Company is recalling Diphenhydramine HCL Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1414-2019·2019-07-03
Premier Pharmacy Labs Recalls Dexamethasone Syringes Due to Sterility Concerns
Premier Pharmacy Labs is recalling 86 syringes of Dexamethasone Sodium Phosphate due to potential sterility issues found during an FDA inspection.
Product
Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-252-10, barcode 0 69623 25210 4.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1417-2019·2019-07-03
Premier Pharmacy Labs Recalls Isoproterenol HCL Bags Due to Sterility Concerns
Premier Pharmacy Labs is recalling 1,235 bags of Isoproterenol HCL in D5W nationwide because FDA inspections found insufficient environmental controls and lack of sterility assurance.
Product
Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-240-57, barcode 0 69623 24057 7.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1420-2019·2019-07-03
Premier Pharmacy Labs Recalls Mitomycin Irrigation Due to Sterility Concerns
Premier Pharmacy Labs is recalling 1,834 vials of Mitomycin Preservative Free Irrigation because FDA inspections found insufficient environmental controls that may compromise sterility.
Product
Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35, barcode 5 69623 16035 0.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1419-2019·2019-07-03
Premier Pharmacy Labs Recalls Lidocaine and Phenylephrine Injection Vials
Premier Pharmacy Labs is recalling 323 vials of Lidocaine 0.5%/Phenylephrine 0.75% Injection due to a lack of sterility assurance identified during an FDA inspection.
Product
Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-176-31, barcode 6 69623 17631 0.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1421-2019·2019-07-03
Premier Pharmacy Labs Recalls Naloxone HCL Injection Due to Sterility Concerns
Premier Pharmacy Labs is recalling Naloxone HCL Preserved Injection because FDA inspections found insufficient environmental controls and lack of process validations, raising concerns about sterility assurance.
Product
Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-235-39, barcode 6 69623 23539 0.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1411-2019·2019-07-03
Premier Pharmacy Labs Recalls Atropine Sulfate Injection Due to Sterility Concerns
Premier Pharmacy Labs is recalling 745 syringes of Atropine Sulfate Injection because FDA inspections found insufficient environmental controls that may compromise sterility.
Product
Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-131-12, barcode 0 69623 13112 6.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1394-2019·2019-06-26
American Health Packaging Recalls Anastrozole Tablets Due to Cleaning Failures
American Health Packaging is recalling 15,386 cartons of Anastrozole Tablets due to potential cross-contamination from cleaning procedure failures.
Product
ANASTROZOLE — ANASTROZOLE (ANASTROZOLE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1440-2019·2019-06-26
Zydus Recalls Anastrozole Tablets Due to Cross-Contamination
Zydus Pharmaceuticals is recalling Anastrozole tablets due to cross-contamination from cleaning failures. The recall covers 1.4 million bottles distributed nationwide.
Product
ANASTROZOLE — ANASTROZOLE (ANASTROZOLE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1409-2019·2019-06-26
P & L Developments Recalls Cetirizine Oral Solution Due to Bacterial Contamination
P & L Developments is recalling 124,512 bottles of Up & Up Children's Cetirizine Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. (118 mL) Bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-178-04, UPC 359726178044.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1408-2019·2019-06-26
P & L Developments Recalls Cetirizine Oral Solution Due to Bacterial Contamination
P & L Developments, LLC is recalling 17,664 bottles of Cetirizine Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle, Distributed by C.D.M.A. Inc., Novi, MI 48376, Quality Choice, NDC 63868-430-04, UPC 635515992474.
Category
Drug
Distribution
Distributed nationwide

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4801–4825 of 11819