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

3851–3875 of 11852

SevereFDA (Drugs)·D-0835-2020·2020-02-19
Pfizer Recalls Fentanyl Citrate Injection Vials Due to Metal Crimp Defects
Pfizer is recalling 38,676 trays of Fentanyl Citrate Injection vials because loose metal overseal crimps may compromise sterility.
Product
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray).
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0840-2020·2020-02-19
Kushim Tablets Recalled for Unapproved Active Ingredients
B and A Trading Corporation is recalling 40 packages of Kushim Tablets marketed without FDA approval. Analysis found the product contains unapproved active ingredients.
Product
Kushim Tablets (Gushim) 45-count packages, Label in foreign language
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0834-2020·2020-02-19
Zydus Recalls Ethacrynate Sodium Injection Vials Due to cGMP Deviations
Zydus Pharmaceuticals is recalling 2,207 vials of Ethacrynate Sodium for Injection due to current Good Manufacturing Practice (cGMP) deviations.
Product
Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-246-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0826-2020·2020-02-12
PD-Rx Recalls Ranitidine Hydrochloride Tablets Due to NDMA Contamination
PD-Rx Pharmaceuticals is recalling specific lots of ranitidine hydrochloride 150 mg tablets because a supplier reported potential NDMA levels above established limits.
Product
ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-
Category
Drug
Distribution
12 states
SevereFDA (Drugs)·D-0825-2020·2020-02-12
Spectrum Chemical Recalls Ranitidine Hydrochloride Powder Due to NDMA Impurity
Spectrum Laboratory Products is recalling Ranitidine Hydrochloride powder due to the presence of NDMA impurity. The product was distributed to pharmacies in 11 US states and internationally.
Product
Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram
Category
Drug
Distribution
11 states
HighFDA (Drugs)·D-0828-2020·2020-02-12
Ascend Recalls Olmesartan Medoxomil Tablets Due to cGMP Deviations
Ascend Laboratories is recalling 192 bottles of Olmesartan Medoxomil 20 mg tablets because they were released in error with an alternate API source before approval.
Product
OLMESARTAN MEDOXOMIL — OLMESARTAN MEDOXOMIL (OLMESARTAN MEDOXOMIL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0822-2020·2020-02-05
Walgreens Acne Cleansing Bar Recalled for Metal Contaminant
Shandex Personal Care Manufacturing Inc. is recalling Walgreens Acne Cleansing Bar due to the presence of a visible metal contaminant.
Product
Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, NDC: 0363-0137-11
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0814-2020·2020-02-05
Sildenafil 200 mg Troche Recall for Labeling and Expiry Issues
Sildenafil 200 mg Troche is recalled for incorrect labeling and being compounded with expired components. Consumers in Texas should check their bottles and contact the manufacturer for instructions.
Product
Sildenafil 200 mg Troche (Clinic)
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0796-2020·2020-01-29
Preferred Pharmaceuticals Recalls Ranitidine Tablets Due to NDMA Impurity
Preferred Pharmaceuticals is recalling 150 mg Ranitidine tablets because of detected NDMA impurity. The affected products were distributed to physicians in seven states.
Product
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1)
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0798-2020·2020-01-29
RemedyRepack Recalls Ranitidine Tablets Due to Potential NDMA Contamination
RemedyRepack Inc. is recalling specific lots of Ranitidine 150 mg tablets because the supplier reported potential Nitrosodimethylamine (NDMA) levels above established limits.
Product
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0793-2020·2020-01-29
Ranitidine Tablets Recalled Due to NDMA Impurity Detection
H.J. Harkins Company is recalling specific lots of Ranitidine 150 mg tablets because NDMA impurity was detected. The product was distributed to physicians in four states.
Product
Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-0795-2020·2020-01-29
Denton Pharma Recalls Ranitidine Tablets Due to NDMA Impurity
Denton Pharma is recalling 467 bottles of Ranitidine Tablets 300 mg because of the presence of NDMA impurity. The affected products were distributed nationwide.
Product
Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0791-2020·2020-01-29
Mylan Recalls Nizatidine Capsules Due to NDMA Impurity Detection
Mylan Pharmaceuticals is recalling Nizatidine Capsules 150 mg because trace amounts of the impurity NDMA were detected in the active ingredient.
Product
Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0800-2020·2020-01-29
Entropic Labs SARM RAD-140 Recalled for Lack of FDA Approval
Entropic Labs is recalling SARM RAD-140 capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0792-2020·2020-01-29
Mylan Recalls Nizatidine Capsules Due to NDMA Impurity Detection
Mylan Pharmaceuticals is recalling Nizatidine Capsules 300 mg because trace amounts of the impurity NDMA were detected in the active ingredient.
Product
Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0794-2020·2020-01-29
Denton Pharma Recalls Ranitidine Tablets Due to NDMA Impurity
Denton Pharma is recalling 1,341 bottles of Ranitidine Tablets 150 mg because the product was found to contain the NDMA impurity.
Product
Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0797-2020·2020-01-29
Preferred Pharmaceuticals Recalls Ranitidine Tablets Due to NDMA Impurity
Preferred Pharmaceuticals is recalling Ranitidine Tablets, 300 mg, because the presence of the NDMA impurity was detected in the product.
Product
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0)
Category
Drug
Distribution
7 states
CriticalFDA (Drugs)·D-0655-2020·2020-01-22
FDA Recalls Unapproved Stallion Platinum 30000 Capsules Containing Tadalafil
Motto International Corp is recalling Stallion Platinum 30000 Capsules because FDA analysis found the unapproved product contains tadalafil.
Product
Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram paper packaging, packaged in 2, 4, 10 count blister cards, Motto International, Dallas, TX
Category
Drug
Distribution
1 state
CriticalFDA (Drugs)·D-0656-2020·2020-01-22
FDA Recalls Rhino 7 Platinum 30000 Capsules for Unapproved Tadafila Content
Motto International Corp is recalling Rhino 7 Platinum 30000 Capsules because FDA analysis found the product contains tadalafil, an unapproved active ingredient.
Product
Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,white,blue,gray text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX
Category
Drug
Distribution
1 state
CriticalFDA (Drugs)·D-0657-2020·2020-01-22
FDA Recalls Panther Platinum 30000 Capsules for Unapproved Tadalfil Content
Motto International Corp is recalling Panther Platinum 30000 Capsules because FDA analysis found the product contains tadalfil and was marketed without an approved NDA or ANDA.
Product
Panther Platinum 30000 Capsules, in green, black background with white, red text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX
Category
Drug
Distribution
1 state
CriticalFDA (Drugs)·D-0864-2020·2020-01-22
Hikma Recalls Ketorolac Tromethamine Injection Due to Particulate Matter
Hikma Pharmaceuticals is recalling specific lots of Ketorolac Tromethamine Injection because of the presence of polydimethylsiloxane particles.
Product
KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0654-2020·2020-01-22
FDA Recalls Unapproved Bull Platinum 30000 Capsules Containing Tadalafil
Motto International Corp is recalling Bull Platinum 30000 Capsules because FDA analysis found the product contains tadalafil, a prescription drug, and it was marketed without an approved NDA or ANDA.
Product
Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, packaged in 2, 4 and 10 count blister cards, Motto International, Dallas, TX
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0700-2020·2020-01-22
Assurance Infusion Recalls BUP 30MG/HYDROM 10MG/ML Injection Due to Sterility Concerns
Assurance Infusion is recalling BUP 30MG/HYDROM 10MG/ML Injection in 20 mL syringes due to a lack of sterility assurance. The recall covers products distributed nationwide in the United States.
Product
BUP 30MG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0711-2020·2020-01-22
Assurance Infusion Recalls BUP/FENT Injection Due to Sterility Concerns
Assurance Infusion is recalling BUP 5.3MG/FENT 1050 MCG/ML Injection in 20 mL syringes due to a lack of sterility assurance.
Product
BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0695-2020·2020-01-22
Assurance Infusion Recalls BUP 21MG/CLON 252MCG/MORP 20MG/ML Injection Syringes
Assurance Infusion is recalling BUP 21MG/CLON 252MCG/MORP 20MG/ML Injection syringes due to a lack of sterility assurance. The recall covers products distributed nationwide.
Product
BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Category
Drug
Distribution
Distributed nationwide

How to read this listing

Filters

3851–3875 of 11852