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

13576–13600 of 17799

ModerateFDA (Drugs)·D-1214-2015·2015-07-15
Apotex Recalls Losartan Potassium Tablets for Uniformity Issues
Apotex Inc. is recalling 23,076 bottles of Losartan potassium tablets 50 mg because the product may not meet blend uniformity specifications.
Product
Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3161-9
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1218-2015·2015-07-15
Amlodipine besylate tablets recalled for inadequate complaint investigation
American Health Packaging is recalling 1,896 cartons of Amlodipine besylate tablets 2.5mg due to inadequate investigation of customer complaints.
Product
Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1229-2015·2015-07-15
American Health Packaging Recalls Lisinopril Tablets Due to CGMP Deviations
American Health Packaging is recalling Lisinopril tablets 40mg due to inadequate investigation of customer complaints. The recall covers 1,516 cartons distributed nationwide.
Product
Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11); 10 blister packs per carton (NDC 68084-064-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1227-2015·2015-07-15
American Health Packaging Recalls Lisinopril Tablets Due to Complaint Investigation Failures
American Health Packaging is recalling 13,532 cartons of Lisinopril 10mg tablets because the firm did not adequately investigate customer complaints.
Product
Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11); 10 blister packs per carton (NDC 68084-061-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1224-2015·2015-07-15
American Health Packaging Recalls Clarithromycin Tablets Due to CGMP Deviations
American Health Packaging is recalling 3,572 cartons of Clarithromycin tablets, USP 500mg, because the firm did not adequately investigate customer complaints.
Product
Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs per carton (NDC 68084-279-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1213-2015·2015-07-15
Apotex Recalls Losartan Potassium Tablets for Blend Uniformity Failure
Apotex Inc. is recalling Losartan potassium tablets 100 mg because they may not meet blend uniformity specifications. The recall covers 23,178 bottles distributed nationwide, in Hawaii, and Puerto Rico.
Product
Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1232-2015·2015-07-15
Hospira Recalls Magnesium Sulfate Injection Due to pH Specification Failure
Hospira Inc. is recalling 106,900 vials of Magnesium Sulfate Injection, USP, 50% because 12-month stability testing failed pH specifications.
Product
Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospira, Inc. 4285 Wesleyan Blvd Rocky Mount, NC 27804 for Hospira, Inc. 275 N Field Drive, Lake Forest, IL 60045. NDC 0409-2168-02
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1228-2015·2015-07-15
American Health Packaging Recalls Lisinopril Tablets Due to CGMP Deviations
American Health Packaging is recalling 5,591 cartons of Lisinopril 20mg tablets nationwide because the firm did not adequately investigate customer complaints.
Product
Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11); 10 blister packs per carton (NDC 68084-062-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1219-2015·2015-07-15
Amlodipine besylate tablets recalled for inadequate complaint investigation
American Health Packaging is recalling Amlodipine besylate tablets 5mg due to CGMP deviations involving inadequate investigation of customer complaints.
Product
Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 68084-505-11); 10 blister packs per carton (NDC 68084-505-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1215-2015·2015-07-15
Apotex Recalls Enalapril Maleate and Hydrochlorothiazide Tablets for Uniformity Issues
Apotex Inc. is recalling 4,584 bottles of Enalapril maleate and hydrochlorothiazide tablets, 10/25 mg, because the product may not meet blend uniformity specifications.
Product
Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1212-2015·2015-07-15
Apotex Recalls Losartan Potassium Tablets Due to Uniformity Issues
Apotex Inc. is recalling Losartan potassium tablets 25 mg because they may not meet blend uniformity specifications. The recall covers 45,708 bottles distributed nationwide, in Hawaii, and Puerto Rico.
Product
Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1221-2015·2015-07-15
American Health Packaging Recalls Azithromycin Tablets Due to CGMP Deviations
American Health Packaging is recalling specific lots of Azithromycin tablets because the firm did not adequately investigate customer complaints.
Product
Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279-11); 3 blister packs per carton (NDC 68084-279-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1222-2015·2015-07-15
American Health Packaging Recalls Azithromycin Tablets Due to Complaint Investigation Failures
American Health Packaging is recalling 838 cartons of Azithromycin 600mg tablets because the firm did not adequately investigate customer complaints.
Product
Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464-11); 3 blister packs per carton (NDC 68084-464-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1223-2015·2015-07-15
American Health Packaging Recalls Azithromycin Tablets Due to CGMP Deviations
American Health Packaging is recalling 2,068 cartons of Azithromycin tablets 250mg due to inadequate investigation of customer complaints.
Product
Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278-11); 10 blister packs per carton (NDC 68084-278-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1231-2015·2015-07-15
Abrams Royal Pharmacy Recalls CORTISOL-MC Capsules for Uniformity Failures
Abrams Royal Pharmacy II is recalling CORTISOL-MC 10mg capsules because they failed uniformity of dosage unit specifications.
Product
CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, ABRAMS ROYAL pharmacy II, 4909 W Park Blvd, Suite 177, Plano, TX 75093 --- NDC 88888-0043-31
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1178-2015·2015-07-08
Lincare Recalls Hydrocodone IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling specific lots of Hydromorphone HCl IV bags because the sterility of the product is not assured.
Product
HYDROmorphone HCl PF, HYDROMORPHONE HCL 1000mg /NS 500mL, Qty: 1 500 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1195-2015·2015-07-08
Lincare Recalls Gentamicin Syringes Due to Sterility Concerns
Lincare, Inc. is recalling Gentamicin 14.4 mg syringes because the sterility of the product is not assured. The recall affects 2 syringes distributed in Arkansas.
Product
GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Packaged in 30 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1167-2015·2015-07-08
Lincare Recalls Vancomycin IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling Vancomycin HCl in Dextrose IV bags because the sterility of the product is not assured. The affected bags were compounded in Arkansas.
Product
Vancomycin HCl in Dextrose, VANCOMYCIN 500mg / D5W 100mL AccuFlo, Qty: 12 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1190-2015·2015-07-08
Lincare Recalls Diphenhydramine Syringes Due to Sterility Concerns
Lincare, Inc. is recalling compounded Diphenhydramine HCl syringes because the sterility of the product is not assured.
Product
Diphenhydramine HCl, Diphenhydramine 25mg / NS 10 ml syringe, Qty: 2 10 mL syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1183-2015·2015-07-08
Lincare Recalls Deferoxamine Mesylate IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling Deferoxamine Mesylate IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Product
DEFEROXAMINE MESYLATE 3gm / NS 240mL Accuflo, Packaged in 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1156-2015·2015-07-08
Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns
Lincare, Inc. is recalling TPN 3:1 bags compounded by United Medical IV Center because the sterility of the product is not assured.
Product
TPN 3:1, 997 ml without lipids Bags, Qty: 3, Base Formula Dextrose 70%, Travasol 10%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Infuvitm Pediat, Rx…
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1155-2015·2015-07-08
Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns
Lincare, Inc. is recalling specific TPN 3:1 bags because their sterility is not assured. The affected products were compounded in May 2015 and distributed in Arkansas.
Product
TPN 3:1, 997 ml with lipids Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Rx…
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1203-2015·2015-07-08
Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling Fluorouracil IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Product
Fluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1188-2015·2015-07-08
Lincare Recalls Vancomycin IV Bags Due to Sterility Concerns
Lincare, Inc. is recalling Vancomycin IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Product
Vancomycin, VANCOMYCIN 750mg / NS 100mL AccuFlo, Qty: 7 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1205-2015·2015-07-08
Lincare Recalls Gentamicin Sulfate Syringes Due to Sterility Concerns
Lincare, Inc. is recalling Gentamicin Sulfate syringes compounded by United Medical IV Center because the sterility of the product is not assured.
Product
Gentamicin Sulfate, GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Qty: 7 30 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Category
Drug
Distribution
1 state

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13576–13600 of 17799