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

10001–10025 of 18028

ModerateFDA (Drugs)·D-0530-2018·2018-02-28
FDA Recalls Tretinoin USP for Prescription Compounding Due to Stability Data Gaps
American Pharmaceutical Ingredients LLC is recalling Tretinoin USP for prescription compounding because the manufacturer lacked stability data and controls to support the assigned expiration dates.
Product
Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-8033-2); 1b) 10g (NDC 58597-8033-3); c) 25g (NDC 58597-8033-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0520-2018·2018-02-28
American Pharmaceutical Ingredients Recalls Stanozolol USP Due to CGMP Deviations
American Pharmaceutical Ingredients LLC is recalling Stanozolol USP for prescription compounding due to lack of stability data and controls supporting expiration dates.
Product
Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597-8525-6); c) 500g (NDC 58597-8525-7); d)1000g (NDC 58597-8525-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0517-2018·2018-02-28
Prilocaine HCl USP Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Prilocaine HCl USP for prescription compounding due to a lack of stability data supporting expiration dates.
Product
Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8028-6); b) 500g (NDC 58597-8028-7); c) 1000g (NDC 58597-8028-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0493-2018·2018-02-28
Flurbiprofen USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients is recalling Flurbiprofen USP for prescription compounding because it lacks stability data to support expiration dates.
Product
Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4); b)100g (NDC 58597-8075-6) ; c) 500g (NDC 58597-8075-7); d) 1000g (NDC 58597-8075-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0479-2018·2018-02-28
FDA Recalls Clindamycin Phosphate Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Clindamycin Phosphate USP for prescription compounding because the manufacturer lacks stability data to support the assigned expiration dates.
Product
Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (NDC 58597-8198-3); b) 100g (NDC 58597-8198-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0478-2018·2018-02-28
American Pharmaceutical Ingredients Recalls Celecoxib USP Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Celecoxib USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.
Product
Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0508-2018·2018-02-28
Lincomycin HCl USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Lincomycin HCl USP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6); b) 500g (NDC 58597-8359-7); c) 1000g (NDC 58597-8359-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0506-2018·2018-02-28
Lidocaine HCl USP Recalled for Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Lidocaine HCl USP for prescription compounding due to a lack of stability data supporting expiration dates.
Product
Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1000g (NDC 58597-8020-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0532-2018·2018-02-28
FDA Recalls Vancomycin HCl Due to Missing Stability Data
American Pharmaceutical Ingredients is recalling Vancomycin HCl USP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Vancomycin HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8091-4); b) 100g (NDC 58597-8091-6); c) 500g (NDC 58597-8091-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0485-2018·2018-02-28
FDA Recalls Diphenhydramine HCl Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Diphenhydramine HCl USP f due to a lack of stability data supporting the assigned expiration date.
Product
Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g ( NDC 58597-8081-4); b) 100g (NDC 58597-8081-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0491-2018·2018-02-28
FDA Recalls Estrone USP for Prescription Compounding Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Estrone USP for prescription compounding because it lacks stability data and controls to support its expiration dates.
Product
Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049-3); b) 100mg (NDC 58597-8049-1); c) 25 g (NDC 58597-8049-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0515-2018·2018-02-28
Pentoxifylline USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Pentoxifylline USP for prescription compounding because it lacks stability data to support its expiration date.
Product
Pentoxifylline USP for prescription compounding, packaged in a) 25g (NDC 58597-8429-4); b) 100g (NDC 58597-8429-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0535-2018·2018-02-28
American Pharmaceutical Ingredients Recalls Ascorbic Acid Due to Stability Data Gaps
American Pharmaceutical Ingredients LLC is recalling Ascorbic Acid USP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6); b) 500g (NDC 58597-8120-7); c) 1000g (NDC 58597-8120-8); d) 5000g (NDC 58597-8120-9); e) 25000g (NDC 58597-8120-3), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland R
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0480-2018·2018-02-28
Clonidine HCl USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Clonidine HCl USP for prescription compounding because it lacks stability data to support its expiration date.
Product
Clonidine HCl USP for prescription compounding, packaged in a) 5g (NDC 58597-8010-2); b) 10g (NDC 58597-8010-3); c) 25g (NDC 58597-8010-4); d)100g (NDC 58597-8010-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0474-2018·2018-02-28
Amitriptyline HCl USP Recalled for Lack of Stability Data
American Pharmaceutical Ingredients is recalling Amitriptyline HCl USP for prescription compounding due to a lack of stability data supporting the assigned expiration dates.
Product
Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500 g (NDC 58597-8003-7), d) 1000 g (NDC 58597-8003-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0498-2018·2018-02-28
FDA Recalls Ketamine HCl USP for Prescription Compounding Due to Stability Data Issues
American Pharmaceutical Ingredients LLC is recalling Ketamine HCl USP for prescription compounding due to a lack of stability data supporting expiration dates.
Product
Ketamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8333-4); b) 100g (NDC 58597-8333-6); c) 500g (NDC 58597-8333-7); d) 1000g (NDC 58597-8333-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0482-2018·2018-02-28
Cyclosporine USP Recalled for Lack of Stability Data and Controls
American Pharmaceutical Ingredients LLC is recalling Cyclosporine USP for prescription compounding due to CGMP deviations regarding stability data and expiration date controls.
Product
Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-8210-2); b) 10g (NDC 58597-8210-3); c) 100g, NDC 58597-8210-6; d) 500g (NDC 58597-8210-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0473-2018·2018-02-28
Nostrum Recalls Calcium Acetate Capsules Due to Foreign Material Presence
Nostrum Laboratories is recalling Calcium Acetate Capsules because foreign tablets or capsules were found in the product.
Product
Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-026-02
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0342-2018·2018-02-21
Senna Laxative Tablets Recalled for Containing Naproxen Sodium
Magno Humphries Laboratories is recalling Senna Laxative tablets that were mislabeled and contained Naproxen Sodium instead.
Product
Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured for: Basic Drugs, Inc., Vandalia, Ohio 45377, UPC Code 3 07610 22020 1.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0600-2018·2018-02-21
FDA Recalls Non-Sterile HCG and Methylcobalamin Injection Vials
The Compounding Pharmacy of America is recalling 5 vials of HCG and Methylcobalamin injection due to non-sterility. The product was distributed in Tennessee and South Carolina.
Product
HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0378-2018·2018-02-21
Sage Products Recalls Oral Cleaning Systems Due to Cross-Contamination
Sage Products Inc. is recalling 852 cases of Oral Cleaning and Suctioning System q2 because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Oral Cleaning and Suctioning System q2. Contains 1 Covered Yankauer, 2 Untreated Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint- solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash solution, 2 Oropharyngeal Suct
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0347-2018·2018-02-21
FDA Recalls Unapproved Limbrel500 Capsules Marketed Without Approval
Primus Pharmaceuticals is recalling Limbrel500 capsules because they were marketed without FDA approval, meaning their safety and efficacy have not been established.
Product
Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-606-16.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0344-2018·2018-02-21
FDA Recalls Unapproved Limbrel Flavocoxid Capsules Nationwide
Primus Pharmaceuticals is recalling 7,826 bottles of Limbrel (flavocoxid 250 mg) capsules because the product was marketed without an approved NDA or ANDA.
Product
Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-601-16.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0360-2018·2018-02-21
Sage Products Recalls Toothette Oral Care Swab System Due to Cross-Contamination
Sage Products Inc. is recalling Toothette Oral Care Short-Term Oral Swab Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Product
Toothette Oral Care Short-Term Oral Swab System with Perox-A-Mint solution, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0345-2018·2018-02-21
Primus Pharmaceuticals Recalls Unapproved Limbrel Flavocoxid Capsules Nationwide
Primus Pharmaceuticals is recalling Limbrel (flavocoxid 500 mg) capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-602-16.
Category
Drug
Distribution
Distributed nationwide

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10001–10025 of 18028