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

15376–15400 of 18001

HighFDA (Drugs)·D-1193-2014·2014-04-16
Terra-Medica Recalls Pleo Not Capsules Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling Pleo Not Capsules 4X because of penicillin cross contamination. The product was distributed in the US, Canada, and the Philippines.
Product
Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppressant/ Decongestant Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2303-1.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1225-2014·2014-04-16
Agila Recalls Etomidate Injection Due to Particulate Matter and Labeling Issues
Agila Specialties Private Ltd. is recalling etomidate injection vials due to potential particulate matter and missing or illegible lot and expiry date labels.
Product
etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per carton (NDC 0069-0006-01) and b) 40 mg/20 mL (2 mg/mL) 20 mL Single Dose Vials (NDC 0069-0006-04), 10 x 20 mL vials per carton (NDC…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1230-2014·2014-04-16
Boehringer Ingelheim Recalls Spiriva HandiHaler Due to Defective Delivery System
Boehringer Ingelheim is recalling Spiriva HandiHaler capsules because a defective delivery system may cause dose delivery out of specification.
Product
SPIRIVA — SPIRIVA (TIOTROPIUM BROMIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1227-2014·2014-04-16
Novartis Recalls Ritalin Tablets Due to Incorrect Medication Guide Labeling
Novartis is recalling Ritalin tablets because the attached Medication Guide contained information for the sustained-release version. The recall is limited to a specific lot distributed nationwide and in Puerto Rico.
Product
RITALIN — RITALIN (METHYLPHENIDATE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1228-2014·2014-04-16
Novartis Recalls Ritalin Tablets Due to Incorrect Medication Guide Labeling
Novartis is recalling 10,781 bottles of Ritalin 20 mg tablets because the attached Medication Guide contained information for Ritalin SR instead of Ritalin Tablets.
Product
RITALIN — RITALIN (METHYLPHENIDATE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1226-2014·2014-04-16
Hospira Recalls Demerol Ampoules Due to Missing Container Labels
Hospira Inc. is recalling 237,850 ampoules of Demerol (meperidine HCL) because the immediate container labels are missing. The recall is nationwide.
Product
Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, Rx only, NDC 0409-1203-01, Hospira, Inc., Lake Forest, IL.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1189-2014·2014-04-09
FDA Recalls HydrOXYzine HCl Tablets Due to Unapproved Ingredient Source
American Health Packaging is recalling HydrOXYzine HCl 50 mg tablets because the active ingredient came from an unapproved source.
Product
HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1187-2014·2014-04-09
Lupin Recalls Suprax Cefixime Oral Suspension Due to Impurity Failure
Lupin Pharmaceuticals is recalling specific lots of Suprax Cefixime for Oral Suspension because the product failed impurity specifications at the 9-month stability station.
Product
Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-03.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1182-2014·2014-04-09
Teva Recalls Duloxetine Capsules Due to Reported Breakage
Teva Pharmaceuticals USA is voluntarily recalling specific lots of Duloxetine Delayed-Release Capsules due to a customer complaint trend regarding capsule breakage.
Product
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 60 capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7542-06
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1183-2014·2014-04-09
Teva Recalls Duloxetine Capsules Due to Reported Capsule Breakage
Teva Pharmaceuticals USA is voluntarily recalling specific lots of Duloxetine Delayed-Release Capsules due to a customer complaint trend regarding capsule breakage.
Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7543-56
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1188-2014·2014-04-09
FDA Recalls HydrOXYzine HCl Tablets Due to Unapproved Ingredient Source
American Health Packaging is recalling HydrOXYzine HCl Tablets because the active pharmaceutical ingredient came from an unapproved source.
Product
HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1185-2014·2014-04-09
Viiv Healthcare Recalls Tivicay Tablets Due to Cross-Contamination with Promacta
Viiv Healthcare is recalling 1,056 bottles of Tivicay (dolutegravir) 50 mg tablets because they were found to contain Promacta (eltrombopag). The recall covers products distributed nationwide, including Puerto Rico.
Product
TIVICAY — TIVICAY (DOLUTEGRAVIR SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1184-2014·2014-04-09
Teva Recalls Duloxetine Capsules Due to Reported Breakage
Teva Pharmaceuticals USA is voluntarily recalling specific lots of Duloxetine Delayed-Release Capsules due to a customer complaint trend regarding capsule breakage.
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7544-56
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1186-2014·2014-04-09
Lupin Recalls Suprax Cefixime Oral Suspension Due to Impurity Failures
Lupin Pharmaceuticals is recalling 4,038 bottles of Suprax Cefixime for Oral Suspension because the product failed impurity specifications at the 9-month stability station.
Product
Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1190-2014·2014-04-09
Teva Recalls QVAR Inhalers Due to Impurity Specification Failures
Teva Pharmaceuticals is recalling specific lots of QVAR inhalation aerosol because they failed impurity specifications during stability testing.
Product
QVAR¿ (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders, Mktd by: Teva Respiratory, LLC, Horsham, PA 19044 Mfd by: 3M Drug Delivery Systems, Northridge, CA 91324.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1179-2014·2014-04-02
Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
Hill Dermaceuticals is recalling 4,142 bottles of Fluocinolone acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.
Product
SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-507-04
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1181-2014·2014-04-02
Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Ear Drops
Hill Dermaceuticals is recalling 13,591 bottles of Fluocinolone Acetonide 0.01% Oil Ear Drops because routine testing found the active ingredient to be subpotent.
Product
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1178-2014·2014-04-02
Hill Dermaceuticals Recalls Subpotent Dermotic Ear Drops
Hill Dermaceuticals is recalling Dermotic ear drops because the active ingredient was found to be subpotent during routine testing.
Product
DERMOTIC — DERMOTIC (FLUOCINOLONE ACETONIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1180-2014·2014-04-02
Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
Hill Dermaceuticals is recalling 7,676 bottles of Fluocinolone Acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.
Product
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-506-04
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1176-2014·2014-04-02
Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
Hill Dermaceuticals is recalling 8,734 bottles of Derma-Smoothe/FS topical oil because the active ingredient was found to be subpotent during routine testing.
Product
DERMA-SMOOTHE/FS — DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1175-2014·2014-04-02
Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
Hill Dermaceuticals is recalling 8,734 bottles of Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.
Product
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-150-04
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1173-2014·2014-04-02
Hill Dermaceuticals Recalls Subpotent DermOtic Oil Ear Drops
Hill Dermaceuticals is recalling DermOtic Oil ear drops because the active ingredient was found to be subpotent during routine testing.
Product
DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1174-2014·2014-04-02
Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
Hill Dermaceuticals is recalling 14,226 bottles of Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.
Product
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-149-04
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1177-2014·2014-04-02
Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Scalp Oil
Hill Dermaceuticals is recalling 7,292 bottles of Derma-Smoothe/FS scalp oil because the active ingredient was found to be subpotent during routine testing.
Product
DERMA-SMOOTHE/FS — DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1169-2014·2014-03-26
Clalis capsules recalled for undeclared sildenafil ingredient
Fabscout Entertainment, Inc. is recalling Clalis capsules because FDA analysis found they contain sildenafil, an undeclared active pharmaceutical ingredient.
Product
Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
Category
Drug
Distribution
Distributed nationwide

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15376–15400 of 18001