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

5101–5125 of 18005

HighFDA (Drugs)·D-0776-2021·2021-09-08
Cyclobenzaprine Hydrochloride Tablets 7.5mg Recalled for Microbial Contamination
Teva Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg (4,992 bottles, batch 1408824A, expiration 08/2023) distributed nationwide due to out-of-specification microbial test results in an excipient ingredient.
Product
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0786-2021·2021-09-08
Akorn Artificial Tears Ointment Recalled for Non-Sterility
Akorn, Inc. is recalling Artificial Tears Ointment eye lubricant due to failure of sterility testing. The product may be contaminated with Bacillus cereus.
Product
Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0790-2021·2021-09-08
Topical Pain Relief AULIEF Recalled for Facility Contamination Risk
China Gel Inc is recalling AULIEF topical pain relief (menthol and camphor) because the product was manufactured in a facility where Burkholderia cepacia contamination was found in other products.
Product
AULIEF — AULIEF (MENTHOL AND CAMOHOR)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0788-2021·2021-09-08
China-Gel Topical Pain Reliever Recall Due to Manufacturing Contamination
China Gel Inc is recalling China-Gel (menthol and camphor) topical pain reliever products due to contamination with B. cepacia found in the manufacturing facility where the product was made.
Product
CHINA-GEL — CHINA-GEL (MENTHOL AND CAMOHOR (SYNTHETIC))
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0789-2021·2021-09-08
China-Gel Topical Pain Reliever Recalled for Manufacturing Facility Contamination
China-Gel Inc is recalling China-Gel White topical pain reliever products due to potential contamination with Burkholderia cepacia found at the manufacturing facility. The recall affects multiple package sizes distributed nationwide and internationally.
Product
CHINA-GEL — CHINA-GEL (MENTHOL AND CAMOHOR (SYNTHETIC))
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0777-2021·2021-09-08
Naproxen Sodium Tablets Recall Due to Manufacturing Quality Deviations
Granules USA, Inc. voluntarily recalled Naproxen Sodium Tablets USP 220 mg due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The recall affects approximately 11.45 million tablets distributed in New York.
Product
Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village, Dundigal-Gandimalsamma Monday, Medchai-Maikhajgir District - 500043, Telangana, INDIA. NDC 62207-762-36
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0787-2021·2021-09-08
Clopidogrel Tablets Recalled for Foreign Matter Contamination
Macleods Pharma USA is recalling Clopidogrel 75 mg tablets due to the presence of foreign matter in the product. The affected lot was distributed nationwide.
Product
CLOPIDOGREL — CLOPIDOGREL (CLOPIDOGREL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0774-2021·2021-09-08
Cyclobenzaprine Hydrochloride Tablets 7.5mg Recalled for Microbial Contamination
Teva Pharmaceuticals is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg due to out-of-specification microbial counts in an ingredient batch. The product was distributed nationwide.
Product
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0775-2021·2021-09-08
Cyclobenzaprine Hydrochloride Tablets 7.5mg Recalled for Microbial Contamination
Teva Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg due to out-of-specification microbial test results in an excipient batch. The affected product was distributed nationwide.
Product
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0784-2021·2021-09-08
Donepezil HCL Tablets 5 mg Recalled for Subpotency
Jubilant Cadista Pharmaceuticals is recalling Donepezil HCL Tablets, USP, 5 mg (Lot # DN120006A, exp. 12/2021) because the tablets are subpotent—meaning they contain less active ingredient than specified. The recall affects 14,544 bottles distributed nationwide.
Product
Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0785-2021·2021-09-08
Lidocaine Ointment USP 5% Recalled for Failed Viscosity Specifications
Teligent Pharma is recalling Lidocaine Ointment USP 5% (114,456 tubes, Lots 15378 and 14418) distributed nationwide because certain lots do not meet viscosity specifications, as determined through routine testing.
Product
Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0768-2021·2021-09-01
SterRx Sodium Bicarbonate in 5% Dextrose Injection Recalled for Sterility Concerns
SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection (1,000 mL bags) nationwide due to lack of assurance of sterility. Patients using affected lots should consult their healthcare provider immediately.
Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0772-2021·2021-09-01
Atovaquone Oral Suspension Recalled for Temperature Abuse
KVK-Tech, Inc. is recalling Atovaquone Oral Suspension due to temperature abuse that caused unusual grittiness in the product. The defect may affect the medication's quality and safety.
Product
ATOVAQUONE ORAL SUSPENSION — ATOVAQUONE ORAL SUSPENSION (ATOVAQUONE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0765-2021·2021-09-01
Fludarabine Phosphate Injection Recalled Due to Sterility Concern
Custopharm, Inc. is recalling Fludarabine Phosphate for Injection, USP 50 mg because the manufacturer detected microbial contamination during environmental monitoring in aseptic manufacturing areas, raising sterility assurance concerns.
Product
FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0773-2021·2021-09-01
Trulicity autoinjector pens recalled for incorrect strength labeling
Eli Lilly & Company is recalling Trulicity (dulaglutide) 0.75 mg autoinjector pens because some contain double the labeled strength. Affected patients may receive an incorrect dose.
Product
TRULICITY — TRULICITY (DULAGLUTIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0770-2021·2021-09-01
Miss Slim capsules recalled for unapproved marketing distribution
HIS ENTERPRISE INC is recalling all lots of Miss Slim capsules (10-count and 30-count boxes) distributed nationwide in the USA because the product was marketed without required FDA approval (ANDA/NDA).
Product
Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0767-2021·2021-09-01
SterRx Sodium Bicarbonate Injection Recalled for Non-Sterility
SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection due to microbial contamination confirmed by third-party laboratory testing. The affected product is a prescription intravenous injection distributed nationwide.
Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0755-2021·2021-09-01
Pi yen chin Ophthalmic Redness Reliever Drops recalled due to sterility concerns
Pi yen chin Ophthalmic Redness Reliever Drops are being recalled because they are actually manufactured as nasal drops and sterility cannot be assured. The product is labeled for ophthalmic use but does not meet the safety standards required for eye application.
Product
Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Chinese writing)International Nature Nutraceuticals, Inc. New York, NY 10002 www.INNHERB.com. Konzon NDC 51367-008-10
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0754-2021·2021-09-01
Carvedilol 25 mg Tablets Recalled Due to Foreign Medication Contamination
RemedyRepack Inc. is recalling Carvedilol 25 mg tablets after discovering that a 500-count source bottle contained two Paroxetine tablets (40 mg), which were then repackaged into 180-count bottles distributed to medical facilities in Virginia and Florida.
Product
Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0766-2021·2021-09-01
Sodium Phenylbutyrate Powder Recalled for Failed Impurities Specifications
SigmaPharm Laboratories is recalling Sodium Phenylbutyrate powder nationwide due to out-of-specification impurity results found during routine testing. Affected bottles have specific lot numbers and expiration dates ranging from May 2023 to May 2024.
Product
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0769-2021·2021-09-01
Erythromycin Topical Solution Recalled for Defective Container Seal
Teligent Pharma, Inc. is recalling Erythromycin Topical Solution USP 2% (60 mL bottles) due to defective containers that may lack seal integrity, potentially allowing contamination or leakage.
Product
Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0758-2021·2021-09-01
PVP Iodine Prep Pads Recalled for Subpotent Active Ingredient
Professional Disposables International is recalling PVP Iodine Prep Pads nationwide because the products are subpotent—containing less active ingredient than specified. The affected prep pads may not provide adequate antiseptic protection.
Product
PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0761-2021·2021-09-01
PDI Povidone-Iodine Swabstick Prep Pads Recalled for Subpotency
Professional Disposables International is recalling PDI Povidone-Iodine Swabsticks nationwide because the product is subpotent—meaning the active ingredient is below the required specification.
Product
PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0759-2021·2021-09-01
PDI Povidone-Iodine Prep Pads Recalled for Subpotent Active Ingredient
Professional Disposables International is recalling PDI Povidone-Iodine Prep Pads distributed nationwide because the product is subpotent—the active ingredient falls below specification. Consumers should stop using affected lots and consult their healthcare provider.
Product
PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0756-2021·2021-09-01
Micafungin for Injection Recalled for Incomplete Package Insert
Xellia Pharmaceuticals USA is recalling Micafungin for Injection 50 mg/vial due to an incomplete package insert that omits required sections on Adverse Reactions, Drug Interactions, and Use in Specific Populations.
Product
Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-036-01
Category
Drug
Distribution
Distributed nationwide

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5101–5125 of 18005