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 the agency’s own highest classification or reported deaths or serious injuries, 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

10976–11000 of 17785

ModerateFDA (Drugs)·D-0446-2017·2017-02-01
Sun Pharmaceutical Recalls BuPROPion Hydrochloride Tablets for Dissolution Failures
Sun Pharmaceutical Industries is recalling 11,618 bottles of buPROPion Hydrochloride Extended-release Tablets due to failed dissolution specifications and stability issues.
Product
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0442-2017·2017-02-01
Mylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder
Mylan LLC is recalling Temozolomide Capsules, 140 mg, due to customer complaints of broken or crushed capsules resulting in loose powder in the bottles.
Product
Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0447-2017·2017-02-01
Cambrex Recalls Mesalamine API Due to Stainless Steel Particulate Matter
Cambrex Charles City Inc is recalling Mesalamine API due to the presence of stainless steel particulate matter detected in the finished product.
Product
Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboard drums. Net weight 40 kg
Category
Drug
Distribution
1 state
LowFDA (Drugs)·D-0448-2017·2017-02-01
Roxane Recalls Azelastine Nasal Spray Due to Defective Delivery System
Roxane Laboratories is recalling 74,108 bottles of Azelastine Hydrochloride Nasal Spray because the delivery system failed droplet size testing.
Product
Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0438-2017·2017-02-01
Qualitest Recalls Dexamethasone Elixir Due to Failed Impurity Specifications
Vintage Pharmaceuticals is recalling 2,568 bottles of Dexamethasone Elixir because the product failed impurity and degradation specifications.
Product
DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0439-2017·2017-02-01
Actavis Recalls Albuterol Sulfate Inhalation Solution Due to Impurities
Actavis Inc is recalling specific lots of Albuterol Sulfate Inhalation Solution because the product failed impurity specifications for a known degradant.
Product
Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0432-2017·2017-01-25
Shire Recalls Pentasa Capsules Due to Presence of Foreign 500 mg Tablets
Shire PLC is recalling 4,520 bottles of Pentasa (mesalamine) 250 mg capsules because 500 mg capsules were found in the bottles.
Product
PENTASA — PENTASA (MESALAMINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0436-2017·2017-01-25
Town and Country Recalls Subpotent HCG Vials Due to Failed Potency
Town and Country Compounding is recalling 101 vials of HCG because potency testing showed 74%, below the required 80-125% range.
Product
HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0435-2017·2017-01-25
Sandoz Recalls Subpotent Donepezil Hydrochloride Tablets
Sandoz Inc. is recalling specific lots of Donepezil Hydrochloride 10 mg tablets because they failed potency tests. The medication may not contain the full prescribed dose.
Product
Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0434-2017·2017-01-25
Perrigo Recalls Clindamycin and Benzoyl Peroxide Gel Due to Mold
L. Perrigo Company is recalling 162,534 tubes of Clindamycin Phosphate and Benzoyl Peroxide Gel because a small number of tubes may contain mold on the cap.
Product
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE — CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (CLINDAMYCIN, BENZOYL PEROXIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0433-2017·2017-01-25
Novum Pharma Recalls Subpotent Novacort Gel Sample Packets
Novum Pharma is recalling Novacort Gel sample packets because the pramoxine hydrochloride content was found to be out of specification.
Product
Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), NDC 69646-704-38 (10 ct. Carton of 1gm samples) / NDC 69646-704-01 (Individual 1gm Samples within Carton), Rx Only, Novum Pharma LLC, Chicago, IL 60654
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0431-2017·2017-01-25
Teva Recalls Risedronate Sodium Tablets for Failed Dissolution Specifications
Teva Pharmaceuticals is recalling 6,800 cartons of Risedronate Sodium Delayed-release Tablets, 35 mg, because they failed dissolution specifications.
Product
Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0428-2017·2017-01-18
Noven Recalls Daytrana Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling 1,068,600 Daytrana transdermal patches nationwide because the delivery system failed mechanical peel force specifications.
Product
DAYTRANA — DAYTRANA (METHYLPHENIDATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0430-2017·2017-01-18
Noven Recalls Daytrana Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because the delivery system failed to meet mechanical peel force specifications.
Product
DAYTRANA — DAYTRANA (METHYLPHENIDATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0425-2017·2017-01-18
Baxter Recalls Premasol Sulfite-Free Amino Acid Injection Due to Discoloration
Baxter Healthcare is recalling 3,528 units of Premasol Sulfite-Free Amino Acid Injection due to yellow discoloration caused by a damaged overpouch.
Product
PREMASOL - SULFITE-FREE (AMINO ACID) — PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0429-2017·2017-01-18
Noven Recalls Daytrana Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because the delivery system failed to meet mechanical specifications.
Product
DAYTRANA — DAYTRANA (METHYLPHENIDATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0427-2017·2017-01-18
Pharm D Solutions Recalls HCG-Vitamin B12 Injection Due to Labeling Error
Pharm D Solutions is recalling 112 vials of HCG-Vitamin B12 injection because the product description incorrectly states the HCG strength as 7500 units instead of 5000 units.
Product
HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1723-20
Category
Drug
Distribution
2 states
LowFDA (Drugs)·D-0426-2017·2017-01-18
Testosterone Cypionate Injection Recalled for Incorrect Excipient Labeling
Pharm D Solutions is recalling Testosterone Cypionate 200 mg/mL vials because the label incorrectly lists grapeseed oil instead of sesame oil.
Product
Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1709-04
Category
Drug
Distribution
2 states
LowFDA (Drugs)·D-0424-2017·2017-01-18
Pfizer Recalls Cytotec Tablets Due to Failed Impurity Specifications
Pfizer is recalling 1,706 cartons of Cytotec (misoprostol) tablets nationwide because the product failed impurity and degradation specifications.
Product
CYTOTEC — CYTOTEC (MISOPROSTOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0366-2017·2017-01-11
Wells Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 265 vials of compounded Methylcobalamin 5,000 mcg/mL Injectable because the product lacks assurance of sterility.
Product
Methylcobalamin 5,000 mcg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0262-2017·2017-01-11
Tri-Coast Pharmacy Recalls HCG/Hydroxycobalamin Vials Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 1,304 vials of compounded HCG/Hydroxycobalamin nationwide due to a lack of assurance of sterility.
Product
HCG/Hydroxycobalamin 5,000 IU/5 mg Vial. Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0345-2017·2017-01-11
Wells Pharmacy Recalls Ceftazidime Ophthalmic Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 46 kits of compounded Ceftazidime Ophthalmic 2.25% due to a lack of assurance of sterility.
Product
Ceftazidime, Lyophilized, Ophthalmic 2.25% Kit, Rx only, Compounded by Wells Pharmacy, Ocala , FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0320-2017·2017-01-11
Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 2 units of TriMix injection because the agency cannot assure the products are sterile.
Product
TriMix, Alprostadil/Phentolamine/Papaverine 100mcg/3mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0268-2017·2017-01-11
Tri-Coast Pharmacy Recalls L-Tyrosine Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 50 vials of compounded L-Tyrosine 10 mg/mL because the products lack assurance of sterility.
Product
L-Tyrosine 10 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0421-2017·2017-01-11
Wells Pharmacy Recalls Vitamin D3 Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 335 vials of Vitamin D3 in Sesame Oil Injectable due to a lack of assurance of sterility.
Product
Vitamin D3 in Sesame Oil Injectable 50,000 IU/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide

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10976–11000 of 17785