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

7701–7725 of 17772

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-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
ModerateFDA (Drugs)·D-1432-2019·2019-07-03
Pramipexole Dihydrochloride Tablets Recalled for GMP Deviations and Cross-Contamination Risk
American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to GMP deviations and possible cross-contamination from cleaning failures.
Product
Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-440-11; NDC Carton: 68084-440-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1431-2019·2019-07-03
Pramipexole Dihydrochloride Tablets Recalled for GMP Deviations and Cross-Contamination Risk
American Health Packaging is recalling Pramipexole Dihydrochloride Tablets due to cleaning procedure failures that may have caused cross-contamination.
Product
Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-793-95; NDC Carton: 68084-793-25
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-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-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-1452-2019·2019-06-26
Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination Risk
Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 1.5 mg due to cross-contamination caused by cleaning failures.
Product
Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1410-2019·2019-06-26
Preferred Pharmaceuticals Recalls Robafen DM Due to Potential Bacterial Contamination
Preferred Pharmaceuticals is recalling specific lots of Robafen DM cough syrup due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bottle, Manufactured for Preferred Pharmaceuticals, Inc., Anaheim, CA 92807 by Major Pharmaceuticals, Livonia, MI 48152, NDC 68788-0841-01
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-1407-2019·2019-06-26
P & L Developments Recalls Cetirizine HCL Oral Solution Due to Contamination
P & L Developments, LLC is recalling 202,068 bottles of Cetirizine HCL Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL, 4 FL. oz. Bottle, Distributed by Dolgencorp, LLC, 100 mission ridge, Goodlettsville, TN 37072, NDC 55910-878-04, UPC 359726178051.
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
SevereFDA (Drugs)·D-1443-2019·2019-06-26
Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination
Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 0.125 mg due to cross-contamination caused by cleaning failures.
Product
Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-16
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1442-2019·2019-06-26
Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination
Zydus Pharmaceuticals is recalling Pramipexole Dihydrochloride Tablets 0.125 mg due to cross-contamination caused by a cleaning failure.
Product
Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1451-2019·2019-06-26
Zydus Recalls Methylprednisolone Tablets Due to Cross-Contamination
Zydus Pharmaceuticals is recalling specific lots of Methylprednisolone tablets due to cross-contamination caused by cleaning failures.
Product
METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1389-2019·2019-06-26
Sun Pharmaceutical Recalls Wal-Fex D Tablets Due to Impurity Testing Failures
Sun Pharmaceutical is recalling Wal-Fex D tablets because testing showed impurity levels above or near specification limits.
Product
Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets, USP, Allergy & Congestion, 30-count box. Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India. UPC 3 11917 19454 7
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1387-2019·2019-06-26
Sun Pharmaceutical Recalls Allergy Relief D Tablets Due to Impurities
Sun Pharmaceutical is recalling Allergy Relief D tablets because testing showed impurities and degradation levels above or near specification limits.
Product
Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 30-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 39131 0
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1449-2019·2019-06-26
Zydus Recalls Methylprednisolone Tablets Due to Cross-Contamination
Zydus Pharmaceuticals is recalling Methylprednisolone tablets due to cross-contamination caused by cleaning failures. The affected lots are distributed nationwide.
Product
METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1393-2019·2019-06-26
Ecolab Recalls QUIK-CARE Hand Sanitizer Due to Incorrect Alcohol Ingredient
Ecolab is recalling 183 cases of QUIK-CARE Aerosol Foam Hand Sanitizer because it was manufactured using the wrong alcohol raw material.
Product
QUIK-CARE — QUIK-CARE (ETHYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1388-2019·2019-06-26
Sun Pharmaceutical Recalls Allergy Relief D Tablets Due to Impurities
Sun Pharmaceutical is recalling Allergy Relief D tablets because testing showed impurities above or near specification limits.
Product
Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 43023 1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1447-2019·2019-06-26
Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination
Zydus Pharmaceuticals is recalling Pramipexole Dihydrochloride Tablets 1 mg due to cross-contamination caused by a cleaning failure.
Product
Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-199-16
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1453-2019·2019-06-26
Zydus Recalls Methylprednisolone Tablets Due to Cross-Contamination
Zydus Pharmaceuticals is recalling specific lots of Methylprednisolone tablets due to cross-contamination caused by cleaning failures.
Product
METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1444-2019·2019-06-26
Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination
Zydus Pharmaceuticals is recalling Pramipexole Dihydrochloride Tablets 0.25 mg due to cross-contamination caused by cleaning failures.
Product
Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-197-16
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1445-2019·2019-06-26
Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross Contamination
Zydus Pharmaceuticals USA Inc is recalling Pramipexole Dihydrochloride Tablets 0.25 mg due to cross contamination caused by a cleaning failure.
Product
Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10
Category
Drug
Distribution
Distributed nationwide

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7701–7725 of 17772