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

9076–9100 of 17974

SevereFDA (Drugs)·D-0098-2019·2018-10-31
Teva Recalls Fortamet Extended-Release Tablets Due to Defective Delivery System
Teva Pharmaceuticals USA is recalling specific lots of Fortamet (metformin HCl) extended-release tablets because some may lack laser drilling, potentially affecting drug release.
Product
Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0090-2019·2018-10-31
Westlab Pharmacy Recalls ADAA Cataract Drops Due to Process Control Issues
Westlab Pharmacy is recalling 222 syringes of ADAA Cataract Drops nationwide due to a lack of process controls.
Product
ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, Westlab Pharmacy, Inc., Gainesville, FL 32607 --- NDC 10002-2579-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0094-2019·2018-10-31
Heritage Pharmaceuticals Recalls Cidofovir Dihydrate Injection Due to Sterility Concerns
Heritage Pharmaceuticals is recalling Cidofovir Dihydrate Injection due to complaints of dried powder on the outside of the bottle, which raises concerns about the product's sterility.
Product
CIDOFOVIR DIHYDRATE — CIDOFOVIR DIHYDRATE (CIDOFOVIR DIHYDRATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0091-2019·2018-10-31
Westlab Pharmacy Recalls Cyclosporine Eye Drops Due to Process Control Issues
Westlab Pharmacy is recalling Cyclosporine 1% Human Eye Drops due to a lack of process controls. The recall covers nationwide distribution.
Product
Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0102-2019·2018-10-31
Teva Recalls Pioglitazone and Metformin Tablets Due to Defective Delivery System
Teva Pharmaceuticals USA is recalling specific lots of Pioglitazone and Metformin tablets because some may lack laser drilling, potentially affecting drug release.
Product
PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda Parkwa
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0089-2019·2018-10-31
Westlab Pharmacy Recalls Alprostadil Injectable Vials Due to Incorrect Formulation
Westlab Pharmacy is recalling 80 vials of Alprostadil 500 mcg/mL Injectable due to an incorrect product formulation. The recall covers nationwide distribution.
Product
Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0096-2019·2018-10-31
Teva Recalls Paliperidone Extended Release Tablets Due to Defective Delivery System
Teva Pharmaceuticals is recalling 27,816 bottles of Paliperidone Extended Release Tablets 3 mg because some tablets may be missing laser drilling, which could affect drug release.
Product
Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0129-2019·2018-10-31
Teva Recalls Metoprolol Succinate Extended Release Tablets Due to Dissolution Failure
Teva Pharmaceuticals USA is recalling 53,451 bottles of Metoprolol Succinate Extended Release Tablets 50 mg because routine stability testing revealed out-of-specification dissolution results.
Product
Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0101-2019·2018-10-31
Teva Recalls Metformin Hydrochloride Extended Release Tablets Due to Defective Delivery System
Teva Pharmaceuticals USA is recalling specific lots of Metformin Hydrochloride Extended Release Tablets 1000 mg because some tablets may be missing laser drilling, which could affect drug release.
Product
Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0100-2019·2018-10-31
Teva Recalls Metformin Hydrochloride Extended Release Tablets Due to Defective Delivery System
Teva Pharmaceuticals USA is recalling 82,291 bottles of Metformin Hydrochloride Extended Release Tablets 1000 mg because some tablets may be missing laser drilling, which could affect drug release.
Product
Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0085-2019·2018-10-31
Valeant Recalls Cortaid Maximum Strength Cream Due to cGMP Deviations
Valeant Pharmaceuticals is recalling specific lots of Cortaid Maximum Strength Cream due to current Good Manufacturing Practice (cGMP) deviations identified during a supplier review.
Product
Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875521011
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0084-2019·2018-10-31
Valeant Recalls Cortaid Intensive Therapy Cooling Spray Due to cGMP Deviations
Valeant Pharmaceuticals is recalling specific lots of Cortaid Intensive Therapy Cooling Spray due to cGMP deviations identified after a supplier recall for microbial contamination.
Product
Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875518028
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0130-2019·2018-10-31
RXQ Compounding Recalls Subpotent Lidocaine and Epinephrine Injection Vials
RXQ Compounding LLC is recalling 395 vials of Lidocaine 1% + Epinephrine 1:100,000 injection solution because testing revealed the product was subpotent.
Product
Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH 45701. NDC 7073197450
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0092-2019·2018-10-31
Lupin Recalls Fluocinolone Acetonide Topical Solution Due to Impurity Failures
Lupin Pharmaceuticals is recalling 2,712 bottles of Fluocinolone Acetonide Topical Solution because stability testing showed total impurities exceeded specifications.
Product
FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0281-2019·2018-10-31
Upsher Smith Recalls Bumetanide Tablets for Unspecified Degradation Product
Upsher Smith Laboratories is recalling 29,080 bottles of Bumetanide 2 mg tablets because the product failed impurity specifications for an unspecified degradation product.
Product
BUMETANIDE — BUMETANIDE (BUMETANIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0083-2019·2018-10-31
Lannett Recalls Hydroxyzine Hydrochloride Syrup Due to Impurities
Lannett Company is recalling 8,324 bottles of Hydroxyzine Hydrochloride Syrup because cleaning procedures caused out-of-specification results for unknown impurities.
Product
HYDROXYZINE HYDROCHLORIDE — HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0086-2019·2018-10-31
Valeant Recalls Cortaid 12-Hour Anti-itch Cream Due to cGMP Deviations
Valeant Pharmaceuticals is recalling 5,016 tubes of Cortaid 12-Hour Advanced Anti-itch Cream due to current Good Manufacturing Practice (cGMP) deviations identified during a supplier review.
Product
Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-0239-2019·2018-10-31
Promise Pharmacy Recalls Prednisolone and Gatifloxacin Ophthalmic Solution Due to Precipitate
Promise Pharmacy LLC is recalling Prednisolone and Gatifloxacin Ophthalmic Solution due to the presence of precipitate. The recall covers nationwide distribution.
Product
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0087-2019·2018-10-31
Lupin Recalls Testosterone Topical Solution Due to Defective Pump
Lupin Pharmaceuticals is recalling 6,752 bottles of Testosterone Topical Solution because the pump mechanism is not working.
Product
TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0074-2019·2018-10-24
CVS Sinus Relief Nasal Spray Recalled for Pseudomonas Contamination
Product Quest Manufacturing LLC is recalling CVS-branded Sinus Relief nasal spray due to failed microbiological testing for Pseudomonas aeruginosa.
Product
Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 43236 5.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0066-2019·2018-10-24
Freeze It Spray Recalled for High Camphor Levels
Product Quest Manufacturing LLC is recalling Freeze It spray cans due to high out-of-specification camphor levels.
Product
FREEZE IT (camphor 0.2% and menthol 3.5%) spray, 118.29 mL (4 fl. oz.) can, Distributed by: Expedite Products, Inc., Tampa, FL 33619 USA, UPC 8 56569 00203 6.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0072-2019·2018-10-24
Mushatt's No. 9 PsoriWash Medicated Wash Recalled for Microbial Contamination
Product Quest Manufacturing LLC is recalling Mushatt's No. 9 PsoriWash Medicated Wash due to microbial contamination and low salicylic acid levels.
Product
Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g) tube, Distributed by Mushatts, LLC, P.O. Box 372476, Satellite Beach, FL 32937, UPC 8 58245 00203 3.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0027-2019·2018-10-24
Dermatone Sunscreen Stick Recalled for Staphylococcus Aureus Contamination
Product Quest Manufacturing LLC is recalling Dermatone No-Touch Sunscreen Sticks because samples tested positive for Staphylococcus aureus.
Product
DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50, Net Wt. 0.49 oz. (13.9g) stick, Distributed by: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 0 20908 05100 3.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0063-2019·2018-10-24
Walgreens Anefrin Nasal Spray Recalled for Manufacturing Quality Issues
Product Quest Manufacturing LLC is recalling 355,056 bottles of Walgreens Anefrin Nasal Spray due to manufacturing conditions that could impact product quality.
Product
Walgreens, NO DRIP, Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Original, 12 Hour, Maximum Strength, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015,NDC 0363-7005-01, UPC 3 11917 18537 8.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0039-2019·2018-10-24
Harmon Face Values Saline Nasal Gel Recalled for Quality Deviations
Product Quest Manufacturing LLC is recalling Harmon Face Values Saline Nasal Gel with Soothing Aloe due to manufacturing deviations that could impact product quality.
Product
Harmon Face Values, Saline Nasal Gel with Soothing Aloe, 0.5 oz. (14.1 g) tube, Distributed by: Harmon Stores, Inc., Union, NJ 07083 USA, UPC 7 27510 00474 7 .
Category
Drug
Distribution
Distributed nationwide

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9076–9100 of 17974