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

8601–8625 of 17772

ModerateFDA (Drugs)·D-0992-2019·2019-03-13
Apotex Recalls Out-of-Sequence Contraceptive Tablets
Apotex Inc. is recalling specific lots of Drospirenone and Ethinyl Estradiol tablets because they may be missing or placed incorrectly in the blister pack.
Product
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Pr
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0994-2019·2019-03-13
Petra Hygienic Systems Recalls Athleticare Hand Soap Due to Triclosan
Petra Hygienic Systems is recalling Athleticare Anti-Bacterial Hand Soap because it contains triclosan, an ingredient no longer permitted in over-the-counter antiseptic wash products.
Product
ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 US Gallon bottles, packaged in 4 x 4 Litres/1.1 US gallons per case, Petra Hygienic Systems, Concord, ON L4K 4RS/ Reno, NV 89511, NDC 42326-550-01, UPC 0 65936 10335 5.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0519-2019·2019-03-13
Jubilant Cadista Recalls Bupropion Hydrochloride Extended-Release Tablets for Dissolution Failure
Jubilant Cadista Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications at a 9-month stability timepoint.
Product
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-0517-2019·2019-03-06
Lupin Recalls Moxifloxacin Ophthalmic Solution Due to Impurity Levels
Lupin Pharmaceuticals is recalling Moxifloxacin Ophthalmic Solution because impurity levels exceeded specifications. The recall covers 674,628 bottles distributed nationwide and in Puerto Rico.
Product
MOXIFLOXACIN — MOXIFLOXACIN (MOXIFLOXACIN)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0509-2019·2019-02-27
ICU Medical Recalls 0.9% Sodium Chloride Injection Due to CGMP Deviations
ICU Medical Inc. is voluntarily recalling 475,320 bags of 0.9% Sodium Chloride Injection due to Current Good Manufacturing Practice (CGMP) deviations.
Product
0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0501-2019·2019-02-27
Torrent Pharma Recalls Losartan Potassium Tablets Due to NDEA Impurity
Torrent Pharma Inc. is recalling Losartan Potassium Tablets, USP, 100 mg, because FDA testing found the impurity N-nitrosodimethylamine (NDEA) above the interim acceptable daily intake level.
Product
LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0505-2019·2019-02-27
Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity
Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA) above acceptable levels.
Product
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0508-2019·2019-02-27
US Compounding Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
US Compounding Inc is recalling 1,686 syringes of Ephedrine Sulfate 50 mg/10 mL because the company cannot ensure the product is sterile.
Product
Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway, AR 800-718-3588, Barcode: 62295308407
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0504-2019·2019-02-27
Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity
Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because FDA labs found the impurity N-nitrosodimethylamine (NDEA) above acceptable levels.
Product
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0502-2019·2019-02-27
Torrent Pharma Recalls Losartan Potassium Tablets Due to NDEA Impurity
Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 50 mg, because FDA testing found the impurity N-nitrosodimethylamine (NDEA) above acceptable levels.
Product
LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90), c) 1000-count bottle (NDC: 13668-409-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0503-2019·2019-02-27
Torrent Pharma Recalls Losartan Potassium Tablets Due to NDEA Impurity
Torrent Pharma Inc. is recalling Losartan Potassium Tablets because FDA testing found the impurity NDEA above acceptable levels.
Product
LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0507-2019·2019-02-27
Dr. Reddy's Recalls Divalproex Sodium Tablets for Dissolution Failure
Dr. Reddy's is recalling 10,656 bottles of Divalproex Sodium Extended-release Tablets because they failed to meet dissolution specifications.
Product
DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0513-2019·2019-02-27
Lupin Recalls Lovastatin Tablets Due to CGMP Deviations
Lupin Pharmaceuticals is recalling Lovastatin 40 mg tablets because the drug substance used was out of specification for impurity results.
Product
LOVASTATIN — LOVASTATIN (LOVASTATIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0498-2019·2019-02-27
Advanced Pharma Recalls Oxytocin Injectable Solution Due to Superpotency
Advanced Pharma Inc. is recalling 672 bags of Oxytocin 20 Units Injectable Solution because the product may contain higher concentrations than labeled.
Product
Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-703-99.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0496-2019·2019-02-27
Advanced Pharma Recalls Fentanyl Syringes Due to Incorrect Expiration Date
Advanced Pharma Inc. is recalling 100 syringes of Fentanyl in 0.9% Sodium Chloride due to an incorrect expiration date on the label.
Product
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx only, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC 42852-210-72
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0511-2019·2019-02-27
Akorn Recalls Moisturizing Lubricant Eye Drops Due to Stability Failure
Akorn Inc is recalling specific lots of Moisturizing Lubricant Eye Drops because they failed stability specifications for Sodium Perborate.
Product
Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerfield IL 60015 NDC 00363-9651-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0515-2019·2019-02-27
Akorn Recalls Clobetasol Propionate Cream Due to Preservative Stability Failure
Akorn Inc. is recalling specific lots of Clobetasol Propionate Emollient Cream 0.05% because stability testing revealed out-of-specification preservative levels.
Product
Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0499-2019·2019-02-27
Advanced Pharma Recalls Oxytocin Injectable Solution Due to Superpotency
Advanced Pharma Inc. is recalling Oxytocin 30 Units Injectable Solution because the product may contain higher concentrations than labeled.
Product
Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-706-50.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0514-2019·2019-02-27
Mometasone Furoate Cream Recalled for NDC Typographical Error
ACP Nimble Buyer, Inc. is recalling Mometasone Furoate Cream due to a typographical error in the National Drug Code (NDC) on the label.
Product
Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0506-2019·2019-02-27
Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities
Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules 180mg because routine stability testing found high out-of-specification impurities.
Product
Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-0512-2019·2019-02-27
Perrigo Recalls Ciclopirox Shampoo Due to Stability Testing Failures
Perrigo New York, Inc. is recalling specific lots of Ciclopirox shampoo 1% because stability testing revealed out-of-specification related substances.
Product
CICLOPIROX — CICLOPIROX (CICLOPIROX)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0516-2019·2019-02-27
Amerigen Recalls Temozolomide Capsules Due to Dissolution Failures
Amerigen Pharmaceuticals is recalling Temozolomide Capsules, 5 mg, because the product failed to meet dissolution specifications.
Product
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-0497-2019·2019-02-27
Advanced Pharma Recalls Oxytocin Injectable Solution Due to Superpotent Drug Concerns
Advanced Pharma Inc. is recalling 12 bags of Oxytocin 10 Units Injectable Solution because the product may contain higher concentrations than labeled.
Product
Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0435-2019·2019-02-20
Promise Pharmacy Recalls Prednisolone Ophthalmic Solution Due to Sterility Concerns
Promise Pharmacy is recalling compounded Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution due to a lack of sterility assurance.
Product
Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0474-2019·2019-02-20
Promise Pharmacy Recalls Procaine HCl Injection Due to Sterility Concerns
Promise Pharmacy, LLC is recalling 11 vials of Procaine HCl 2% injection due to a lack of sterility assurance. The product was distributed nationwide.
Product
Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide

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8601–8625 of 17772