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

17976–18000 of 18050

SevereFDA (Drugs)·D-1428-2012·2012-08-08
Zydus Recalls Metformin Tablets Due to Foreign Substance Presence
Zydus Pharmaceuticals is recalling 1,176 bottles of Metformin Hydrochloride 1000 mg tablets because a pharmacist reported brown specks and metal shavings on the tablets.
Product
Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-030-10.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1436-2012·2012-08-08
Watson Recalls Caziant Tablets Due to High Impurity Levels
Watson Laboratories is recalling Caziant tablets because high levels of impurities were detected. Consumers should stop using the product and contact their healthcare provider.
Product
Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1432-2012·2012-08-08
Cadence Pharmaceuticals Recalls OFIRMEV Acetaminophen Injection Due to Particulate Matter
Cadence Pharmaceuticals is recalling OFIRMEV (acetaminophen) injection vials due to the visible presence of particulate matter.
Product
OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL Vials per carton, Rx only, Manufactured for: Cadence Pharmaceuticals, Inc., San Diego, CA 92130, NDC 43825-102-01, UPC 3 43825 10201 7.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1438-2012·2012-08-08
West-Ward Recalls Fosphenytoin Sodium Injection Due to Particulate Matter
West-Ward Pharmaceutical Corp. is recalling specific lots of Fosphenytoin Sodium Injection because particles were found in stability and retain samples.
Product
FOSPHENYTOIN SODIUM — FOSPHENYTOIN SODIUM (FOSPHENYTOIN SODIUM)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-1439-2012·2012-08-08
Apotex Recalls Dorzolamide HCI/Timolol Maleate Ophthalmic Solution Due to Particulates
Apotex Inc. is recalling specific lots of Dorzolamide HCI/Timolol Maleate Ophthalmic Solution because they may contain small particulates.
Product
Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1431-2012·2012-08-08
Mallinckrodt Recalls Hydrocodone and Acetaminophen Oral Solution Due to Expired Flavoring
Mallinckrodt Inc. is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen Oral Solution because expired flavoring was used during manufacturing.
Product
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1437-2012·2012-08-08
West-Ward Recalls Fosphenytoin Sodium Injection Due to Particulate Matter
West-Ward Pharmaceutical Corp. is recalling specific lots of Fosphenytoin Sodium Injection because particles were found in stability and retain samples.
Product
FOSPHENYTOIN SODIUM — FOSPHENYTOIN SODIUM (FOSPHENYTOIN SODIUM)
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-1430-2012·2012-08-08
Mallinckrodt Recalls Hydrocodone and Acetaminophen Oral Solution for Low Potency
Mallinckrodt Inc. is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen Oral Solution because the hydrocodone ingredient was found to be subpotent.
Product
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1441-2012·2012-08-08
Axcentria Recalls Infants' Mapap Due to Incorrect Expiration Date Labeling
Axcentria Pharmaceuticals LLC is recalling 13,128 bottles of Infants' Mapap in Michigan because the outer packaging displays an incorrect expiration date.
Product
Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor, Distributed by MAJOR PHARMACEUTICALS, Livonia, MI --- NDC 0904-5255-30,
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1425-2012·2012-08-01
Grandpa Brands Recalls Dent's Extra Strength Toothache Gum
Grandpa Brands Co is recalling Dent's Extra Strength Toothache Gum due to superpotent benzocaine levels. Consumers should stop using the product.
Product
Dent's Extra Strength Toothache Gum, (benzocaine 20%), Net Wt. .035 Oz.. (1 g) box, C.S. Dent & Co., Erlanger, KY
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1427-2012·2012-08-01
Stat Rx USA Recalls Tizanidine Tablets Due to Labeling Error
Stat Rx USA is recalling 51 bottles of Tizanidine 4 mg tablets because some labels incorrectly identified Actavis as the manufacturer.
Product
Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1426-2012·2012-08-01
Fougera Recalls Erythromycin Topical Solution Due to Plasticizer Contamination
Fougera Pharmaceuticals is recalling 444 bottles of Erythromycin Topical Solution USP, 2%, due to potential trace contamination with Di-Octyl Phthalate.
Product
Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Pharmaceuticals, Inc., Melville, New York 11747, NDC 0168-0215-60, UPC 3 0168-0215-60 0.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1419-2012·2012-07-25
Hospira Recalls Morphine Sulfate Injection Cartridges Due to Overfilling
Hospira Inc. is recalling Morphine Sulfate Injection cartridges that contain 2.2 mL instead of the labeled 1 mL, posing a risk of overdose.
Product
Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10 Carpujects/carton, CII, Rx only, Hospira, Inc., Lake Forest, IL ---- NDC 0409-1258-30
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1421-2012·2012-07-25
Luitpold Recalls Epinephrine Injection Ampules Due to Particulate Matter
Luitpold Pharmaceuticals is recalling Epinephrine Injection ampules because of the presence of particulate matter. The affected lot was distributed nationwide.
Product
Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For IV and IC Use after Dilution, Rx Only, American Regent, Inc., Shirely, NY 11967 --NDC 0517-1071-25
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1418-2012·2012-07-25
Meda Recalls Prefera OB One Gel Capsules Due to Undeclared Ingredients
Meda Pharmaceuticals is recalling Prefera OB One Gel Capsules because the product labeling failed to list several inactive ingredients, including D&C Red #33.
Product
Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For: Alaven Pharmaceutical LLC Marietta, GA 30062, NDC 68220-086-30
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1422-2012·2012-07-25
Pack Pharmaceuticals Recalls Ciprofloxacin Tablets Due to Missing Labels
Pack Pharmaceuticals is voluntarily recalling 4,848 bottles of Ciprofloxacin 500 mg tablets because two bottles were found missing container labels.
Product
CIPROFLOXACIN — CIPROFLOXACIN (CIPROFLOXACIN)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1417-2012·2012-07-25
Qualitest Recalls Hydroxyzine Hydrochloride Oral Solution Due to Impurity
Vintage Pharmaceuticals is recalling 73,746 bottles of Hydroxyzine Hydrochloride Oral Solution because high levels of a known impurity were detected.
Product
HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-1310-58, UPC 3 0603-1310-58 4.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1420-2012·2012-07-25
Pitocin Injection Recalled for Incorrect Storage Temperature Labeling
JHP Pharmaceuticals is recalling specific lots of Pitocin (Oxytocin) injection due to a labeling error that displays an incorrect lower storage temperature limit.
Product
PITOCIN — PITOCIN (OXYTOCIN)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1423-2012·2012-07-25
Bayer Recalls Midol Complete Due to Labeling Mismatch
Bayer is recalling 119,412 cartons of Midol Complete because the blister strip label does not match the carton regarding the maximum daily dose.
Product
MIDOL COMPLETE — MIDOL COMPLETE (MIDOL COMPLETE)
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-1424-2012·2012-07-25
Bayer Recalls Midol Complete Due to Labeling Mismatch
Bayer Healthcare is recalling 48,528 cartons of Midol Complete because the maximum daily dose stated on the blister strip does not match the carton label.
Product
MIDOL COMPLETE — MIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1413-2012·2012-07-18
Noven Recalls Daytrana Methylphenidate Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because the delivery system is miscalibrated or defective, potentially affecting drug delivery.
Product
DAYTRANA — DAYTRANA (METHYLPHENIDATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1412-2012·2012-07-18
Trizivir Tablets Recalled Due to Potential Foreign Tablet Contamination
GlaxoSmithKline is recalling Trizivir tablets because they may contain foreign Lexiva tablets. Patients should stop using the affected lot and contact their healthcare provider.
Product
Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets, Rx only, Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709 by: GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 49702-217-18
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1416-2012·2012-07-18
VistaPharm Recalls Hydrocodone and Acetaminophen Oral Solution Due to Impurities
VistaPharm is recalling specific lots of Hydrocodone Bitartrate & Acetaminophen Oral Solution because impurities exceeded specifications during stability testing.
Product
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1410-2012·2012-07-18
AstraZeneca Recalls Nexium Capsules Due to Foreign Product Contamination
AstraZeneca is recalling 2,556 bottles of Nexium 40 mg capsules because some may contain Nexium 20 mg capsules intended for the Japanese market.
Product
NEXIUM — NEXIUM (ESOMEPRAZOLE MAGNESIUM)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1411-2012·2012-07-18
Qualitest Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Impurities
Vintage Pharmaceuticals is recalling 54,431 bottles of Hydrocortisone and Acetic Acid Otic Solution because impurity levels exceeded specifications.
Product
HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.
Category
Drug
Distribution
Distributed nationwide

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17976–18000 of 18050