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

11676–11700 of 18028

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
ModerateFDA (Food)·F-2078-2016·2016-09-14
Nature Made Vitamin D Tablets Recalled for Yeast and Mold
Pharmavite is recalling specific lots of Nature Made Vitamin D tablets because they may exceed specifications for yeast and mold.
Product
Nature Made(R) D3 1000IU, 350 count, UPC 0-31604-04070-3
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
SevereFDA (Drugs)·D-1468-2016·2016-08-31
Mylan Amlodipine Tablets Recalled for CGMP Deviations
Mylan Institutional is recalling Amlodipine Besylate Tablets 10 mg because they were produced with active ingredients not manufactured according to Good Manufacturing Practices.
Product
Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1466-2016·2016-08-31
Mylan Amlodipine Tablets Recalled for CGMP Deviations
Mylan Institutional, Inc. is recalling Amlodipine Besylate Tablets because they were not manufactured according to Good Manufacturing Practices.
Product
Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1463-2016·2016-08-31
Talon Compounding Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns
Talon Compounding Pharmacy is recalling Sermorelin and Sermorelin/GHRP-2 injections because the FDA cannot assure the products are sterile.
Product
Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1467-2016·2016-08-31
Mylan Amlodipine Besylate Tablets Recalled for CGMP Deviations
Mylan Institutional, Inc. is recalling Amlodipine Besylate Tablets, 5 mg, because they were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Product
Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-451-56, c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-451-19; and d)…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1462-2016·2016-08-31
Talon Compounding Pharmacy Recalls Human Chorionic Gonadotropin Injection Due to Sterility Concerns
Talon Compounding Pharmacy is recalling 6,500 vials of Human Chorionic Gonadotropin Injection nationwide due to a lack of assurance of sterility.
Product
Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000 iu with B12, (f) 6000 iu, (g) 7500 iu, (h) 7500 iu with B12, (i)11,000 iu, (j)11,000 iu with B12, (k) 15,000 iu, (l) 20,000 iu, (m) 20,000 iu with B12, 10 mL sterile…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1470-2016·2016-08-31
Teva Recalls Amoxicillin Oral Suspension Due to Potency Issues
Teva North America is recalling Amoxicillin for Oral Suspension because stability testing showed the drug was superpotent.
Product
AMOXICILLIN — AMOXICILLIN (AMOXICILLIN)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1471-2016·2016-08-31
Actavis Recalls Acetasol HC Otic Solution Due to Impurity Failure
Actavis Inc is recalling 672 bottles of Acetasol HC otic solution because stability testing showed an out-of-specification related compound at the 12-month time point.
Product
Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1472-2016·2016-08-31
Actavis Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Impurities
Actavis Inc. is recalling 2,543 bottles of Hydrocortisone and acetic acid otic solution because stability testing showed out-of-specification results for a related compound.
Product
Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1464-2016·2016-08-31
Stratus Pharmaceuticals Recalls Remeven Cream Due to Crystallization
Stratus Pharmaceuticals is recalling Remeven Cream because the product has crystallized. The recall covers specific lots of 5.0 oz and 9.0 oz tubes.
Product
Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1465-2016·2016-08-31
Exact-Rx Recalls Urea Cream Due to Crystallization
Exact-Rx Inc. is recalling specific lots of Urea (50% Urea in a Cream Base) because crystals formed in the product.
Product
Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1469-2016·2016-08-31
Akorn Recalls Desoximetasone Gel Due to Impurity Specification Failure
Akorn, Inc. is recalling Desoximetasone Gel USP, 0.05%, because the product failed impurity specifications at the 9-month stability time point.
Product
Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1458-2016·2016-08-24
Golden State Medical Supply Recalls Venlafaxine Hydrochloride Extended-Release Capsules
Golden State Medical Supply Inc. is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, due to failed dissolution specifications.
Product
Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS.
Category
Drug
Distribution
Distributed nationwide

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11676–11700 of 18028