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

1601–1625 of 11819

HighFDA (Drugs)·D-0981-2023·2023-08-09
Heparin intravenous bags recalled due to sterility assurance failure
Central Admixture Pharmacy Services is recalling 448 bags of heparin 7500 units in 0.9% sodium chloride IV solution due to lack of assurance of sterility. Validation data for decontamination cycles was not established.
Product
heparin 7500 units added to 0.9% sodium chloride 1000mL, CONCENTRATION = 7.5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7009-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1079-2023·2023-08-09
Fentanyl Injectable Recalled Due to Unvalidated Sterilization Process
Central Admixture Pharmacy Services is recalling approximately 6,770 fentanyl syringes distributed nationwide due to lack of validated sanitization data. The injectable medication may not have proper sterility assurance.
Product
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0997-2023·2023-08-09
Neonatal TPN Starter Bags Recalled Due to Sterility Validation Failure
Central Admixture Pharmacy Services is recalling 356 neonatal TPN starter bags due to lack of validation data for decontamination cycles. The sterility of the affected lots cannot be assured.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1035-2023·2023-08-09
Cardioplegia Solution Recalled Due to Insufficient Sterility Assurance
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lacking validation data for decontamination cycles, creating insufficient assurance of sterility in this injectable product.
Product
CARDIOPLEGIA SOLUTION, 12 mEq K, Maintenance 4:1 in Ringer's Low Potassium, IV Bag, total volume = 504.8 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0205-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1036-2023·2023-08-09
Cardioplegia IV Solution Recalled for Sterilization Validation Deficiency
Central Admixture Pharmacy Services is recalling 88 bags of Cardioplegia Solution (Lot 36-255943) due to lack of assurance of sterility and insufficient validation of decontamination cycles. The product is used during cardiac surgery.
Product
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, IV Bag, total volume = 810 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0103-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1044-2023·2023-08-09
HYDROmorphone Injectable Syringes Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services Inc is recalling HYDROmorphone injectable syringes because sterilization cycles were not validated. The recall affects 2,717 units distributed nationwide.
Product
HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0990-2023·2023-08-09
Potassium Phosphate IV Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling potassium phosphate intravenous bags due to lack of sterility assurance and missing validation data for decontamination processes. The recall affects 234 bags distributed nationwide.
Product
potassium phosphate, 30 mmole added to 0.9% sodium Chloride 500mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7016-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1023-2023·2023-08-09
Cardioplegia Solution recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 56 bags of Cardioplegia Solution due to lack of sterility assurance and missing validation data for decontamination cycles. Product was distributed nationwide.
Product
CARDIOPLEGIA SOLUTION, 7.5 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 238.75 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0007-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1026-2023·2023-08-09
IV Transplant Solution Recalled Due to Inadequate Sterilization Validation
Central Admixture Pharmacy Services is recalling 12 IV bags of Transplant Solution nationwide (Lot 36-252141) because the sterilization decontamination cycles lack proper validation, creating a sterility assurance deficiency.
Product
TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextrose 70% 21.3 ml; IV Bag, Total Volume = 165 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0014-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1046-2023·2023-08-09
FDA Recalls Fentanyl Syringes for Sterility Assurance Failure
Central Admixture Pharmacy Services Inc. has recalled 100 fentanyl syringes (Lot 17-273267) because validation data for sanitization cycles is lacking, preventing assurance of sterility. The product was distributed nationwide.
Product
fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0947-2023·2023-08-09
Rocuronium Injection Syringes Recalled for Sterility Assurance Deficiency
FDA recalls 77,554 rocuronium syringes nationwide due to lack of sterility assurance and inadequate validation data for sterilization processes. The drug was repackaged by Central Admixture Pharmacy Services, Inc.
Product
rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0936-2023·2023-08-02
Oxacillin for Injection recalled nationwide due to sterility concerns
Sagent Pharmaceuticals is recalling Oxacillin for Injection USP due to lack of sterility assurance. The recall affects multiple lots distributed nationwide.
Product
Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0937-2023·2023-08-02
Oxacillin for Injection Recalled Nationwide for Lack of Sterility Assurance
Sagent Pharmaceuticals is recalling Oxacillin for Injection due to lack of assurance of sterility. The product was distributed to healthcare facilities nationwide.
Product
Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0945-2023·2023-08-02
SCA Pharmaceuticals Fentanyl-Bupivacaine Injectable Recall Due to Manufacturing Deviations
SCA Pharmaceuticals is recalling 183 bags of a fentanyl-bupivacaine injectable due to current Good Manufacturing Practice (cGMP) deviations. The product was distributed to Kentucky and New Jersey.
Product
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0943-2023·2023-08-02
Safe Tussin PM Night Time Cough Relief Recalled for Manufacturing Deviation
Kramer Laboratories is recalling Safe Tussin PM Night Time Cough Relief due to use of non-food-grade lubricant in the mixing vessel during manufacturing. Affected product: lot 8639, expiration 8/2023, distributed nationwide.
Product
Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1297-2023·2023-08-02
Zinc Sulfate Monohydrate ingredient recalled for potential lead contamination
Jost Chemical Co is recalling Zinc Sulfate Monohydrate, USP, because it may contain elevated levels of lead. This pharmaceutical ingredient was distributed to multiple countries including the United States.
Product
Zinc Sulfate Monohydrate, USP, Powder. Net Wt: 55 lb / 25 kg. Jost Chemical 8150 Lackland, St. Louis, MO 63114. Caution: For Manufacturing, Processing, or Repacking.
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0940-2023·2023-08-02
Methylphenidate Hydrochloride Tablets Recalled Due to Metal Contamination
Sun Pharmaceutical Industries is recalling 7,313 bottles of Methylphenidate Hydrochloride Tablets (20mg) due to metal embedded in some tablets. No illnesses have been reported.
Product
METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0935-2023·2023-08-02
Oxacillin Injectable Recalled for Failure to Assure Sterility
Sagent Pharmaceuticals is recalling Oxacillin for Injection (1 gram vials, Lot OXG301) due to lack of assured sterility. Approximately 65,710 vials distributed nationwide are affected.
Product
Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0944-2023·2023-08-02
Testosterone Cypionate-Propionate Compounded Injectable Recalled for Sterility Assurance Deficiency
New Vitalis Pharmacy is recalling its Testosterone Cypionate-Propionate injectable medication due to lack of assurance of sterility. The recall affects 102 vials distributed nationwide.
Product
Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0928-2023·2023-07-26
Rocuronium Bromide Injectable Recalled Due to CGMP Violations
Advanced Compounding Solutions is recalling Rocuronium Bromide 10 mg/mL injectables (lot #20230524-530F73) nationwide due to CGMP violations. Production spaces adjacent to the manufacturing area may have been compromised.
Product
ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0933-2023·2023-07-26
Norepinephrine injectable recalled due to lack of sterility assurance
SterRx is recalling 92,148 bags of norepinephrine injectable due to lack of assurance of sterility. The prescription medication was distributed nationwide.
Product
Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-602-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0930-2023·2023-07-26
Sodium Bicarbonate Injectable Solution Recalled for Sterility Assurance Issues
SterRx is recalling 137,304 bags of Sodium Bicarbonate in 5% Dextrose Injection nationwide because the manufacturer cannot assure the product meets sterility standards. Affected lots have expiration dates from July 2023 through February 2024.
Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0926-2023·2023-07-26
Succinylcholine Chloride Injectable Drug Recalled Nationwide for Manufacturing Facility Contamination Risk
Advanced Compounding Solutions is recalling 493 syringes of succinylcholine chloride injection due to potential contamination from manufacturing facility violations affecting product sterility.
Product
SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042; NDC: 71546-083-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0934-2023·2023-07-26
Norepinephrine Injectable Recalled Due to Lack of Sterility Assurance
SterRx recalled 2,088 bags of Norepinephrine 32 mg per 250 mL (Lot #490100) distributed nationwide due to lack of sterility assurance. The recall affects a critical care medication used in intensive care settings.
Product
Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0932-2023·2023-07-26
Norepinephrine injectable medication recalled nationwide for sterility assurance
SterRx recalled 125,598 bags of norepinephrine injectable medication nationwide because the manufacturer could not guarantee the product's sterility. The recalled medication has expiration dates from July 2023 to April 2024.
Product
Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-577-01.
Category
Drug
Distribution
Distributed nationwide

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1601–1625 of 11819