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

2151–2175 of 18005

HighFDA (Drugs)·D-0064-2024·2023-10-25
Compounded Intranasal Lidocaine-Oxymetazoline Solution Recalled Due to Sterility Assurance
Pine Pharmaceuticals is recalling 860 syringes of intranasal lidocaine-oxymetazoline solution distributed nationwide due to lack of sterility assurance. Lot 67808 expired 10/23/2023.
Product
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0059-2024·2023-10-25
Compounded Lidocaine-Phenylephrine Injectable Recalled Due to Sterility Assurance Issues
Pine Pharmaceuticals is recalling 9,673 vials of compounded lidocaine-phenylephrine injectable due to lack of assurance of sterility. Affected lots were distributed nationwide.
Product
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0050-2024·2023-10-25
Compounded Bevacizumab Injectable Syringes Recalled for Sterility Assurance
Pine Pharmaceuticals is recalling approximately 2,862 syringes of compounded Bevacizumab 1.25 MG/0.05 ML Solution for Injection due to lack of assurance of sterility. The product was distributed nationwide.
Product
Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0063-2024·2023-10-25
FDA Recalls Tropi-Phen Ophthalmic Solution Due to Sterility Assurance Failure
Pine Pharmaceuticals has recalled 662 dropper units of Tropi-Phen ophthalmic solution due to lack of sterility assurance. The affected lots were distributed nationwide.
Product
Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0051-2024·2023-10-25
Vancomycin Intraocular Injection Recalled Due to Sterility Assurance Failure
Pine Pharmaceuticals is recalling 26 vials of Vancomycin 1 MG/0.1 ML intraocular injection (Lot #69985) due to lack of assurance of sterility. The product was distributed nationwide.
Product
Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0065-2024·2023-10-25
Foscarnet Sodium Injectable Recalled Due to Lack of Sterility Assurance
Pine Pharmaceuticals is recalling Foscarnet Sodium 2.4mg/0.1 mL injectable syringes nationwide due to lack of assurance of sterility. No illnesses or injuries have been reported.
Product
Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0055-2024·2023-10-25
FDA Recalls Compounded Ophthalmic Solution Due to Sterility Concerns
Pine Pharmaceuticals recalls Tropi-Phen ophthalmic solution due to lack of sterility assurance. The 15 mL droppers were distributed nationwide and customers should not use affected lots.
Product
Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0054-2024·2023-10-25
Calcium Gluconate Inhalation Solution Recalled Due to Sterility Concerns
Pine Pharmaceuticals is recalling Calcium Gluconate 2.5% inhalation solution due to lack of sterility assurance. Patients should stop using affected syringes and contact their healthcare provider.
Product
Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0053-2024·2023-10-25
Calcium Gluconate Ophthalmic Irrigation Solution Recall Due to Sterility Concerns
Pine Pharmaceuticals is recalling Calcium Gluconate Ophthalmic Irrigation Solution 1% (Lot #69802) due to lack of sterility assurance. The 128 bags distributed nationwide may pose infection risk if used.
Product
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0045-2024·2023-10-25
Over-the-counter drugs from Family Dollar recalled for improper storage
Dollar Tree Distribution recalled approximately 4.3 million over-the-counter drug products sold by Family Dollar stores nationwide after discovering they were stored outside of labeled temperature requirements.
Product
Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0043-2024·2023-10-25
Ophthalmic Solution Recalled Due to Subpotent Ketorolac Levels
MYDRIATIC-4 ophthalmic solution is being recalled because ketorolac levels fell below the required 90-110% specification. The product was distributed to physician offices nationwide.
Product
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0044-2024·2023-10-25
Sun Pharmaceutical Bupropion Extended-Release Tablets Recalled for Failed Dissolution
Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets (150 mg), lot HAD0360A, due to failed dissolution specifications. The 144 bottles were distributed nationwide and may not dissolve at the intended rate.
Product
BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0042-2024·2023-10-18
FDA recalls BREXAFEMME tablets due to cross-contamination with ezetimibe
The FDA is recalling BREXAFEMME antifungal tablets due to potential cross-contamination with ezetimibe during manufacturing, with two lot numbers distributed nationwide.
Product
BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 75788-115-04
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0037-2024·2023-10-11
FDA Recalls Dr. Berne's MSM Drops Due to Non-Sterility Concerns
Dr. Berne's MSM DROPS 5% Solution was recalled by the FDA for non-sterility issues. Lot 6786, with expiration date March 31, 2025, is distributed nationwide and internationally.
Product
Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001111.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0023-2024·2023-10-11
FDA Recalls Fentanyl Injectable for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling fentanyl 50 mcg/mL injectable nationwide due to lack of assurance of sterility. The product was distributed in 100 mL bags (lot 17-275322, expires 10/3/2023).
Product
fentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0013-2024·2023-10-11
Fentanyl Injectable Solution Recalled Over Sterility Concerns
Central Admixture Pharmacy Services Inc. is recalling fentanyl injectable solution nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
Product
fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0007-2024·2023-10-11
Phenylephrine Injectable Syringes Recalled for Sterility Assurance
Central Admixture Pharmacy Services Inc is recalling phenylephrine injectable syringes nationwide due to lack of assurance of sterility. The recall affects 19,510 units distributed across multiple lot numbers.
Product
PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0032-2024·2023-10-11
FDA Recalls HYDROmorphone Syringes for Sterility Assurance Issue
Central Admixture Pharmacy Services has recalled approximately 398 HYDROmorphone in dextrose 5% injectable syringes nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider immediately.
Product
HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0031-2024·2023-10-11
FDA Recalls Hydromorphone Syringes Over Sterility Assurance Issue
Central Admixture Pharmacy Services Inc is recalling 2,664 syringes of HYDROmorphone injectable solution (30 mg/30 mL) distributed nationwide. The recall was initiated due to lack of assurance of sterility.
Product
HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0019-2024·2023-10-11
Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Issue
Central Admixture Pharmacy Services is recalling fentanyl 100 mcg/2 mL syringes due to a lack of assurance of sterility. The affected lot was distributed nationwide.
Product
fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0009-2024·2023-10-11
Fentanyl Injectable Solution Recalled for Sterility Assurance Defect
Central Admixture Pharmacy Services is recalling fentanyl 10 mcg/mL injectable solution due to lack of assurance of sterility. The recall affects 1,767 three-milliliter syringes distributed nationwide.
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-0008-2024·2023-10-11
FDA Recalls Rocuronium Syringes Due to Sterility Assurance Issue
The FDA is recalling rocuronium 50 mg/5 mL syringes from Central Admixture Pharmacy Services Inc due to lack of assurance of sterility. Approximately 1,389 syringes with affected lot numbers have been distributed nationwide.
Product
rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0016-2024·2023-10-11
FDA Recalls Injectable Fentanyl-Bupivacaine Mixture for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling fentanyl-bupivacaine injectables due to lack of assurance of sterility. The recalled 250 mL bags were distributed nationwide.
Product
fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0035-2024·2023-10-11
Drug eye drops recalled for manufacturing practice deviations nationwide
Dr. Berne's Organic Castor Oil Eye Drops are being recalled due to manufacturing practice deviations. The voluntary recall affects 1,744 bottles distributed nationally and internationally.
Product
Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], Certified Organic by Organic Certifiers.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0002-2024·2023-10-11
Ketamine syringes recalled for lack of sterility assurance
CAPS Inc. is recalling 4,775 ketamine syringes nationwide due to lack of confirmed sterility assurance during manufacturing. No illnesses have been reported, but affected healthcare facilities should quarantine and return unused product.
Product
ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
Category
Drug
Distribution
Distributed nationwide

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2151–2175 of 18005