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

13676–13700 of 18042

SevereFDA (Drugs)·D-1329-2015·2015-08-19
Mylan Recalls Cytarabine Injection Vials Due to Particulate Matter
Mylan Institutional LLC is recalling 8,340 vials of Cytarabine Injection due to the presence of particulate matter. The affected product was distributed nationwide.
Product
Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1326-2015·2015-08-19
Baxter Recalls Sodium Chloride Injection Due to Particulate Matter and Sterility Concerns
Baxter Healthcare is recalling 0.9% Sodium Chloride Injection USP due to complaints of particulate matter, leaks, and missing port protectors.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
2 states
HighFDA (Food)·F-2957-2015·2015-08-19
ASN Dietary Supplements Recalled for Unapproved Drug Claims
James G. Cole, Inc. is recalling all ASN brand products nationwide because they are misbranded, adulterated, and unapproved new drugs.
Product
ALL ASN products: The ASN products are in capsule or powdered form and bear the ASN label. *********the List of ASN products***************************** AFINITY WHEY PROTEIN; DHEA; HUMAGRO Homeopathic Growth Hormone 4c; PHYTOBOL; TESTRX; TRIBESTRONE II;
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1325-2015·2015-08-19
Dr. Reddy's Recalls Rivastigmine Tartrate Capsules for Dissolution Failures
Dr. Reddy's Laboratories is recalling Rivastigmine Tartrate capsules because they failed to meet dissolution specifications.
Product
RIVASTIGMINE TARTRATE — RIVASTIGMINE TARTRATE (RIVASTIGMINE TARTRATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1321-2015·2015-08-19
Sensodyne Toothpaste Recalled for Wood Fragments
GlaxoSmithKline is recalling Sensodyne Complete Protection toothpaste because wood fragments were found in the product.
Product
SENSODYNE COMPLETE PROTECTION — SENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2953-2015·2015-08-19
Chemi-source Recalls DHEA 25mg Capsules for Labeling Inaccuracy
Chemi-source, Inc. is recalling DHEA 25mg capsules because they may contain more DHEA than the label claims.
Product
DHEA 25mg, 60 count, sku: #6-09492-41001-6, and 90 count, sku: #6-09492-41002-3; 12 bottles/case.
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-1322-2015·2015-08-19
Sensodyne Complete Protection Recalled for Wood Fragments
GlaxoSmithKline is recalling Sensodyne Complete Protection toothpaste because wood fragments were found in the product. Consumers should stop using the affected tubes.
Product
SENSODYNE COMPLETE PROTECTION — SENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1319-2015·2015-08-19
Biotene Sodium Fluoride Toothpaste Recalled for Wood Fragments
GlaxoSmithKline is recalling Biotene toothpaste because wood fragments were found in the product. Consumers should stop using the affected tubes.
Product
BIOTENE — BIOTENE (SODIUM FLUORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1324-2015·2015-08-19
Sensodyne Toothpaste Recalled Due to Wood Fragments
GlaxoSmithKline is recalling 325,504 tubes of Sensodyne toothpaste because wood fragments were found when the product was extruded.
Product
SENSODYNE — SENSODYNE (STANNOUS FLUORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1317-2015·2015-08-19
Biotene Gentle Mint Gel Recalled for Wood Fragments
GlaxoSmithKline is recalling Biotene Gentle Mint Gel tubes because wood fragments were found in the product. Consumers should stop using the affected lots.
Product
biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1323-2015·2015-08-19
Sensodyne Toothpaste Recalled Due to Wood Fragments
GlaxoSmithKline is recalling Sensodyne toothpaste tubes because wood fragments were found in the product. Consumers should stop using the affected tubes.
Product
SENSODYNE — SENSODYNE (STANNOUS FLUORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1318-2015·2015-08-19
Biotene Fluoride Toothpaste Recalled for Wood Fragments
GlaxoSmithKline is recalling Biotene fluoride toothpaste because wood fragments were found in the product. Consumers should stop using the affected tubes.
Product
BIOTENE — BIOTENE (SODIUM FLUORIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1327-2015·2015-08-19
Fresenius Kabi Recalls Hydralazine Hydrochloride Injection Due to Incorrect Expiration Date
Fresenius Kabi USA is recalling 93,000 vials of Hydralazine Hydrochloride Injection because the expiration date printed on the secondary packaging is incorrect.
Product
HYDRALAZINE HYDROCHLORIDE — HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighCPSC·15219·2015-08-18
Merck Recalls Temodar and Temozolomide Bottles with Cracked Caps
Merck is recalling approximately 276,000 bottles of Temodar and Temozolomide capsules because cracked caps may fail to keep young children from accessing the medication.
Product
Bottles with cracked caps containing Temodar® (Temozolomide) and Temozolomide (generic) capsules
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1309-2015·2015-08-12
Apothecary Shoppe Recalls SIU-Tri-Mix Injection Due to Sterility Concerns
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 30/2/20 Injection in Oklahoma due to a lack of documentation proving proper environmental monitoring during production.
Product
SIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1398-47
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1297-2015·2015-08-12
Apothecary Shoppe Recalls SIU-Phent Injection Due to Sterility Concerns
The Apothecary Shoppe LLC is recalling SIU-Phent .4 mg/PGE1 20 mcg/mL Injection due to a lack of documentation for environmental monitoring during production.
Product
SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1802-97
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1296-2015·2015-08-12
Apothecary Shoppe Recalls Papaverine and Phentolamine Injection Due to Sterility Concerns
The Apothecary Shoppe is recalling specific lots of SIU-Papav/Phentol 30/1 mg/mL Injection due to a lack of documentation for environmental monitoring during production.
Product
SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1295-2015·2015-08-12
Apothecary Shoppe Recalls Papaverine and Phentolamine Injection Due to Sterility Concerns
The Apothecary Shoppe LLC is recalling specific vials of Papaverine and Phentolamine Injection due to a lack of documentation confirming proper environmental monitoring during production.
Product
SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1461-57
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-1313-2015·2015-08-12
Apothecary Shoppe Recalls Prostaglandin E1 Injection Due to Sterility Concerns
The Apothecary Shoppe LLC is recalling SIU-Prostaglandin E1 500 mcg/mL Injection vials in Oklahoma due to lack of documentation for environmental monitoring during production.
Product
SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-1293-2015·2015-08-12
Apothecary Shoppe Recalls Testosterone Cypionate Injection Due to Sterility Concerns
The Apothecary Shoppe is recalling specific lots of Testosterone Cypionate Injection due to a lack of documentation confirming proper environmental monitoring during production.
Product
SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2896-05
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-1301-2015·2015-08-12
Apothecary Shoppe Recalls Prostaglandin E1 Injection Due to Sterility Concerns
The Apothecary Shoppe LLC is recalling SIU-Prostaglandin E1 20 mcg/mL Injection due to a lack of documentation ensuring proper environmental monitoring during production.
Product
SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-3169-01
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-1283-2015·2015-08-12
Teva Recalls Amphetamine Tablets Due to Unknown Impurity
Teva Pharmaceuticals is recalling specific lots of amphetamine tablets because they failed impurity specifications. The product contains an unknown impurity.
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1289-2015·2015-08-12
Apothecary Shoppe Recalls S-Methylcobalamin Injection Due to Sterility Concerns
The Apothecary Shoppe is recalling S-Methylcobalamin 1000 mcg/mL Injection because documentation for environmental monitoring during production was missing.
Product
S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1962-40
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-1312-2015·2015-08-12
Apothecary Shoppe Recalls SO-Acetylcysteine Ophthalmic Solution for Sterility Concerns
The Apothecary Shoppe LLC is recalling SO-Acetylcysteine 10% Sterile Ophthalmic Solution due to lack of documentation for environmental monitoring during production.
Product
SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-1300-2015·2015-08-12
Apothecary Shoppe Recalls SIU-Phent Injection Due to Sterility Documentation Issues
The Apothecary Shoppe is recalling SIU-Phent .8/PGE1 20 mcg/mL Injection vials because proper environmental monitoring documentation was missing during production.
Product
SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2557-43
Category
Drug
Distribution
1 state

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13676–13700 of 18042