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

11626–11650 of 17987

SevereFDA (Drugs)·D-1498-2016·2016-09-14
Allergy Laboratories Recalls Ephedrine Sulfate Injection Due to Sterility Concerns
Allergy Laboratories is recalling Ephedrine Sulfate Injection vials because an FDA inspection raised concerns about product sterility.
Product
Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY 10605.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1489-2016·2016-09-14
Amerisource Health Services Recalls Mispackaged Amphetamine Extended-Release Capsules
Amerisource Health Services is recalling 115 cartons of 25 mg amphetamine extended-release capsules due to unit dose mispackaging where blister cavities may contain more than one capsule.
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 25 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1482-2016·2016-09-14
Amerisource Recalls Mispackaged Amphetamine Tablets Due to Unit Dose Errors
Amerisource Health Services is recalling 2,276 cartons of 10 mg amphetamine tablets because blister cavities may contain more than one tablet.
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1495-2016·2016-09-14
Teva Recalls Linezolid Injection Due to Manufacturing Deviations
Teva North America is voluntarily recalling 92,480 containers of Linezolid Injection 600 mg/300 mL due to CGMP deviations. The recall covers products distributed nationwide and in Puerto Rico.
Product
Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1485-2016·2016-09-14
Amerisource Recalls Mispackaged Amphetamine Tablets Due to Dosing Errors
Amerisource Health Services is recalling 156 cartons of 30 mg amphetamine tablets because blister cavities may contain more than one tablet.
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 30 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1483-2016·2016-09-14
Amerisource Recalls Mispackaged Amphetamine Tablets Due to Unit Dose Errors
Amerisource Health Services is recalling 1,416 cartons of 15 mg amphetamine tablets because blister cavities may contain more than one tablet.
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 15 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1486-2016·2016-09-14
Amerisource Health Services Recalls Mispackaged Amphetamine Extended-Release Capsules
Amerisource Health Services is recalling 834 cartons of amphetamine extended-release capsules because blister cavities may contain more than one tablet or capsule.
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 10 mg 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1484-2016·2016-09-14
Amerisource Health Services Recalls Mispackaged Amphetamine Tablets
Amerisource Health Services is recalling 867 cartons of 20 mg amphetamine tablets due to unit dose blister cavities containing more than one tablet.
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 20 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1491-2016·2016-09-14
Zydus Recalls Bromocriptine Mesylate Capsules Due to Stability Test Failures
Zydus Pharmaceuticals is recalling 14,808 bottles of Bromocriptine Mesylate 5 mg capsules because stability samples failed impurity tests.
Product
BROMOCRIPTINE MESYLATE — BROMOCRIPTINE MESYLATE (BROMOCRIPTINE MESYLATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1481-2016·2016-09-14
Amerisource Recalls Mispackaged Dextroamphetamine and Amphetamine Tablets
Amerisource Health Services is recalling 221 cartons of mixed amphetamine tablets due to unit dose mispackaging, where blister cavities may contain more than one tablet.
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 5 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1494-2016·2016-09-14
Teva Recalls Argatroban Injection Due to Manufacturing Deviations
Teva North America is voluntarily recalling 1,299 bags of Argatroban Injection due to Current Good Manufacturing Practice (CGMP) deviations.
Product
ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton).
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1493-2016·2016-09-14
Lupin Recalls Amlodipine Besylate Tablets Due to CGMP Deviations
Lupin Limited is recalling Amlodipine Besylate tablets because they were manufactured using active pharmaceutical ingredients that failed specifications.
Product
AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-1496-2016·2016-09-14
Teva Recalls Eptifibatide Injection Vials Due to Manufacturing Deviations
Teva North America is voluntarily recalling 14,661 vials of Eptifibatide Injection due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.
Product
Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1490-2016·2016-09-14
Amerisource Recalls Mispackaged Adderall XR 30 mg Extended-Release Capsules
Amerisource Health Services is recalling 761 cartons of Adderall XR 30 mg capsules due to unit dose mispackaging where blister cavities may contain more than one capsule.
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 30 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1497-2016·2016-09-14
Teva Recalls Ondansetron Injection Vials Due to Manufacturing Deviations
Teva North America is recalling 13,223 vials of Ondansetron Injection USP due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.
Product
Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1480-2016·2016-09-14
Isomeric Pharmacy Recalls Methylprednisolone Acetate/Lidocaine Injection Due to Sterilization Issue
Isomeric Pharmacy Solution, LLC is recalling Methylprednisolone Acetate/Lidocaine HCl Injection because excessive sterilization time may cause difficulty resuspending particles.
Product
Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109,
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1488-2016·2016-09-14
Amerisource Recalls Mispackaged Adderall XR 20 mg Extended-Release Capsules
Amerisource Health Services is recalling 666 cartons of Adderall XR 20 mg capsules due to unit dose mispackaging where blister cavities may contain more than one capsule.
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, CII 20 mg, 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1479-2016·2016-09-14
Stason Recalls Selegiline HCl Tablets Due to Dissolution Failure
Stason Pharmaceuticals is recalling Selegiline HCl tablets 5mg due to out-of-specification dissolution results for stability samples.
Product
Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06
Category
Drug
Distribution
1 state
LowFDA (Drugs)·D-1492-2016·2016-09-14
Lupin Recalls Amlodipine Besylate Tablets Due to CGMP Deviations
Lupin Limited is recalling Amlodipine Besylate tablets because they were manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Product
AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-1474-2016·2016-09-07
Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels
Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.
Product
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47477-5, Shade 02 (VF-N)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1475-2016·2016-09-07
Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels
Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.
Product
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47478-2, Shade 03 (MF-N)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1477-2016·2016-09-07
Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels
Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.
Product
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48240-4, Shade 05 (D-G)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1478-2016·2016-09-07
Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels
Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.
Product
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48241-1, Shade 06 (D-G)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1473-2016·2016-09-07
Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels
Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.
Product
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47476-8, Shade 01 (VF-N)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1476-2016·2016-09-07
Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels
Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.
Product
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47479-9, Shade 04 (M-N)
Category
Drug
Distribution
Distributed nationwide

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11626–11650 of 17987