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

11651–11675 of 17987

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
ModerateFDA (Drugs)·D-1459-2016·2016-08-24
Venlafaxine Hydrochloride Extended-Release Capsules Recalled for Dissolution Failures
Golden State Medical Supply Inc. is recalling 40,631 bottles of Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, due to out-of-specification dissolution results.
Product
Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1460-2016·2016-08-24
Zydus Recalls Venlafaxine Hydrochloride Capsules for Dissolution Failures
Zydus Pharmaceuticals is recalling 223,776 bottles of Venlafaxine Hydrochloride ER capsules because retained samples failed dissolution specifications.
Product
VENLAFAXINE HYDROCHLORIDE — VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1461-2016·2016-08-24
Zydus Recalls Venlafaxine Hydrochloride Capsules for Dissolution Failures
Zydus Pharmaceuticals USA Inc. is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Capsules because retained samples failed dissolution specifications.
Product
VENLAFAXINE HYDROCHLORIDE — VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1457-2016·2016-08-24
Actavis Recalls Glipizide 2.5 mg Extended-Release Tablets for Dissolution Failure
Actavis Inc is recalling specific lots of Glipizide 2.5 mg Extended-Release tablets because they failed to meet dissolution specifications.
Product
Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1455-2016·2016-08-17
Teva Recalls Albuterol Sulfate Syrup Due to Foreign Particles
Teva North America is recalling 8,052 bottles of Albuterol Sulfate Syrup because black particles were found in the product.
Product
Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1456-2016·2016-08-17
Spectrum Chemical Recalls Zinc Acetate Due to Excess Lead Levels
Spectrum Laboratory Products is recalling Zinc Acetate, Crystal, USP, because it contains lead levels exceeding USP monograph limits.
Product
Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-1452-2016·2016-08-10
Let's Talk Health Recalls Unapproved Oxygen Nasal Wash Solution
Let's Talk Health is recalling 417 bottles of Oxygen Nasal Wash because the product was marketed without FDA approval and does not comply with nasal decongestant monograph requirements.
Product
Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1454-2016·2016-08-10
Isomeric Pharmacy Recalls Betamethasone Injectable Suspension Due to Particle Issues
Isomeric Pharmacy Solution is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension due to potential drug clumps and larger particle sizes.
Product
Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isomeric Pharmacy Solution, 2401 Foothill Dr., Salt Lake City, UT 84109
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1453-2016·2016-08-10
Teva Recalls Children's Qnasl Nasal Aerosol for Content Uniformity Failure
Teva North America is recalling Children's Qnasl nasal aerosol canisters due to failed spray content uniformity tests. The FDA classified this as a Class III recall.
Product
Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample; Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Drug Delivery Systems, Northridge, CA…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1447-2016·2016-08-03
Medicap Pharmacy Recalls Acetylcyst 10% Ophthalmic Solution for Sterility Concerns
Medicap Pharmacy is recalling Acetylcyst 10% Ophthalmic Solution because sterile products were not produced in a controlled, sterile environment.
Product
Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94.
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-1450-2016·2016-08-03
Sagent Pharmaceuticals Recalls Oxacillin for Injection Due to Particulate Matter
Sagent Pharmaceuticals is recalling Oxacillin for Injection due to the presence of small, dark particulate matter in the solution after reconstitution.
Product
Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only, Mfd for Sagent Pharmaceuticals, Schaumberg, IL, 60196, USA, Made in India, NDC 25021-163-69
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1449-2016·2016-08-03
Teva Recalls Divalproex Sodium Tablets Due to Failed Specifications
Teva North America is recalling Divalproex Sodium Delayed-release Tablets because they failed tablet specifications. The recall covers 14,370 units distributed nationwide and in Puerto Rico.
Product
Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1448-2016·2016-08-03
Actavis Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures
Actavis Inc is recalling Dextroamphetamine Sulfate Extended-Release Capsules because they failed to meet dissolution specifications. The recall covers 8,062 units distributed nationwide.
Product
DEXTROAMPHETAMINE SULFATE — DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
Category
Drug
Distribution
Distributed nationwide

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11651–11675 of 17987