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

2226–2250 of 11852

HighFDA (Drugs)·D-0061-2023·2022-11-23
Phenoxybenzamine Hydrochloride Capsules Recalled for Failed Specifications
Par Pharmaceutical is recalling Phenoxybenzamine Hydrochloride Capsules 10mg nationwide due to failed impurity and degradation specifications. The recalled lot may not meet pharmaceutical quality standards.
Product
Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Forumulations Private Limited,9/215, Pudupakkam, Kelambakkam - 603 103. NDC 49884-038-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0060-2023·2022-11-23
ImprimisRx Timolol-Latanoprost Ophthalmic Drops Recalled for Subpotent Active Ingredient
ImprimisRx is recalling 960 bottles of compounded Timolol-Latanoprost ophthalmic drops nationwide. Affected batches contain less than 90% of the labeled latanoprost amount.
Product
Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0064-2023·2022-11-23
FDA Recalls Labetalol Injectable for Potential Cross-Contamination Risk
FDA recalls Nephron's Labetalol HCl Injection vials due to manufacturing deviations that could cause cross-contamination. The recall affects 34,020 vials distributed nationwide.
Product
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0058-2023·2022-11-16
Octreotide Acetate Injection Recalled for Glass Particle Contamination
Viatris Inc is recalling Octreotide Acetate Injection due to glass particles found in syringes. Approximately 22,400 syringes of lot #AJ21002 (expiration 03/2024) were distributed nationwide.
Product
OCTREOTIDE ACETATE — OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0028-2023·2022-11-09
FDA Recalls Vital Care Autologous Tears Serum Due to Sterility Assurance Failure
Vital Care Compounder's Autologous Tears Serum Full Strength has been recalled due to manufacturing defects that cannot assure product sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0049-2023·2022-11-09
Prescription Injectable Medication Recalled for Sterility Assurance Failure
Pharmacy Plus, Inc. recalled a prescription injectable medication (Papaverine/Phentolamine/Prostaglandin) because FDA inspection found the product was produced in a manner that cannot guarantee sterility. Lot 65976 (BUD 10/27/2022) was distributed in AL, LA, MS, and TN.
Product
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0042-2023·2022-11-09
Pharmacy Plus Injectable Drug Recall Due to Sterility Assurance Failure
Pharmacy Plus, Inc. recalled a compounded injectable medication (56 vials) due to manufacturing processes that cannot guarantee product sterility. Distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0039-2023·2022-11-09
Mitomycin Injection Recalled Due to Lack of Sterility Assurance
Vital Care Compounder is recalling 185 syringes of Mitomycin Injection due to lack of sterility assurance discovered during FDA inspection. The product cannot guarantee sterility.
Product
MITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0032-2023·2022-11-09
Cyclosporin 0.07% Ophthalmic Solution Recalled Due to Sterility Concerns
Pharmacy Plus recalls 67 bottles of Cyclosporin 0.07% ophthalmic solution across four states due to manufacturing process that cannot guarantee sterility.
Product
CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0052-2023·2022-11-09
Prostaglandin E1 Injection Recalled Due to Sterility Assurance Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Prostaglandin E1 Injection Solution after FDA inspection found the products were manufactured in a manner that cannot guarantee sterility.
Product
PROSTAGLANDIN E1 INJECTION SOLUTION 500MCG/ML SOLUTION, 1 ML vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0024-2023·2022-11-09
Buprenorphine and Naloxone Sublingual Tablets Recalled for Foreign Substance
Sun Pharmaceutical is recalling buprenorphine and naloxone sublingual tablets (8 mg/2 mg) due to a foreign substance. Affected lots DNC1129A and DNC1740A were distributed nationwide.
Product
BUPRENORPHINE AND NALOXONE — BUPRENORPHINE AND NALOXONE (BUPRENORPHINE AND NALOXONE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0027-2023·2022-11-09
Acetylcysteine Eye Drops Recalled for Sterility Assurance Issues
Acetylcysteine ophthalmic solution 5% from Vital Care Compounder is recalled due to manufacturing deficiencies that cannot ensure product sterility. The affected product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0026-2023·2022-11-09
Acetylcysteine eye drops recalled for sterility assurance defect
Pharmacy Plus Inc. is recalling acetylcysteine 10% eye drop solution due to manufacturing issues that cannot guarantee sterility. Lot 66895 was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
ACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0035-2023·2022-11-09
Lidocaine/Phenylephrine Injectable Solution Recalled for Sterility Defect
Pharmacy Plus Inc.'s Lidocaine/Phenylephrine injectable solution is recalled due to manufacturing process deficiencies that cannot guarantee product sterility. The recall affects 389 syringes distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0046-2023·2022-11-09
Injectable Papaverine/Phentolamine Recalled Due to Sterility Assurance Failure
Pharmacy Plus, Inc. is recalling 242 vials of papaverine/phentolamine injection because FDA inspection found the products were produced in conditions that cannot guarantee sterility. The affected lots were distributed to AL, LA, MS, and TN.
Product
PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0038-2023·2022-11-09
Methylcobalamin Injection Recalled for Lack of Sterility Assurance
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 514 vials of methylcobalamin injection solution. FDA inspection found manufacturing conditions that do not assure sterility.
Product
METHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0041-2023·2022-11-09
Compounded injectable medication recalled for lack of sterility assurance
Pharmacy Plus Inc. (Vital Care Compounder) is recalling compounded PAP/PHEN/PROSTAG/ATROPINE injections distributed in four states due to manufacturing conditions that cannot guarantee product sterility.
Product
PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0055-2023·2022-11-09
Sterile Talc Powder Recalled Due to Sterility Assurance Failure
Pharmacy Plus, Inc. is recalling sterile talc powder vials after FDA inspection found the manufacturing process cannot guarantee sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
TALC, STERILE POWDER, 5 GM vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0053-2023·2022-11-09
Semaglutide Injection Recalled Due to Sterility Assurance Deficiency
The FDA is recalling semaglutide injection from Vital Care Compounder for lack of assurance of sterility. The recall affects specific lots distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0048-2023·2022-11-09
Compounded Injectable Medication Recalled for Lack of Sterility Assurance
Vital Care Compounder is recalling an injectable medication (Papaverine/Phentolamine/Prostaglandin) because FDA inspection found production methods cannot guarantee product sterility. The recalled lot was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150/5/50MCG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0034-2023·2022-11-09
Laureth-9 Injectable Solution Recalled for Lack of Sterility Assurance
A compounded Laureth-9 injectable solution has been recalled after the FDA found the manufacturing process could not guarantee sterility. The recalled product (lot 66513) was distributed in AL, LA, MS, and TN.
Product
LAURETH-9 INJ 2% Solution, 30 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0043-2023·2022-11-09
Pharmacy Compounded Injection Recalled for Sterility Assurance Failure
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling a compounded injectable medication because manufacturing did not ensure sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 150MG/10MG/100MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0057-2023·2022-11-09
Voriconazole ophthalmic solution recalled for sterility concerns
Pharmacy Plus, Inc. (Vital Care Compounder) is recalling Voriconazole Ophthalmic Solution 2% because FDA inspection found manufacturing processes cannot guarantee the product's sterility.
Product
VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0029-2023·2022-11-09
Compounded sterile drug solution recalled due to manufacturing sterility failure
Vital Care Compounder is recalling Brilliant Blue G Solution due to inability to assure product sterility. The recall involves 86 vials (Lot 60448) distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
BRILLIANT BLUE G, 0.04% Solution, 2 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0054-2023·2022-11-09
Pharmacy Plus Eye Solution Recalled for Sterility Assurance Issues
Pharmacy Plus is recalling SERUM TEARS IN NSAL 20% Ophthalmic Solution due to lack of assurance of sterility. FDA inspection found the manufacturing process could not guarantee the product's sterility.
Product
SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states

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2226–2250 of 11852