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

11326–11350 of 17785

SevereFDA (Drugs)·D-0013-2017·2016-10-19
Leiter's Compounding Recalls Ophthalmic Solution Due to Sterility Concerns
Leiter's Compounding is recalling Cyclopentolate HCl, Tropicamide, and Phenylephrine HCl ophthalmic solution because the filters used to produce the products were recalled, creating a lack of assurance of sterility.
Product
Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0040-2017·2016-10-19
Pharmedium Recalls Fentanyl Syringes Due to Stability Data Concerns
Pharmedium Services is recalling 1,561 syringes of fentanyl citrate because stability data does not support the expiry dates, posing a risk of potency loss.
Product
fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3339.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0075-2017·2016-10-19
Pharmedium Recalls Midazolam Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 26,079 syringes of midazolam HCl because stability data does not support the expiration dates, posing a risk of reduced potency.
Product
midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3356.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0042-2017·2016-10-19
Pharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency
Pharmedium Services, LLC is recalling 1,735 syringes of fentanyl citrate because stability data does not support the expiration dates, posing a risk of reduced drug potency.
Product
fentaNYL Citrate, 5 mcg per mL, 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3479.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0090-2017·2016-10-19
Pharmedium Recalls Succinylcholine Chloride Injection Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 2,495 syringes of succinylcholine chloride injection because stability data does not support the expiration dates, posing a risk of loss of potency.
Product
succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3357.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0024-2017·2016-10-19
Teva Recalls Amikacin Sulfate Injection Due to Manufacturing Deviations
Teva Pharmaceuticals USA is voluntarily recalling 11,844 vials of Amikacin Sulfate Injection due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials).
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0070-2017·2016-10-19
Pharmedium Recalls Methadone Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 7,006 syringes of methadone HCl because stability data does not support the expiration dates, posing a risk of reduced potency.
Product
methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6120.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0036-2017·2016-10-19
Pharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency
Pharmedium Services, LLC is recalling 110 syringes of fentanyl citrate because stability data does not support the expiry date, posing a risk of reduced drug potency.
Product
fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3236.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0056-2017·2016-10-19
Pharmedium Recalls Ketamine HCl Injection Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 12,173 syringes of ketamine HCl Injection because stability data does not support the expiration dates, posing a risk of reduced potency.
Product
ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3348.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0100-2017·2016-10-19
Allergan Recalls Tazorac Gel 0.05% Due to Content Uniformity Failures
Allergan Sales, LLC is recalling 17,112 tubes of Tazorac (tazarotene) Gel 0.05% because the product failed content uniformity specifications.
Product
TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers, Manufactured by: Allergan Inc., Irvine, CA 92512. UPC: 300238335159.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0010-2017·2016-10-19
Leiter's Compounding Recalls Atropine Sulfate Ophthalmic Solution Due to Sterility Concerns
Leiter's Compounding is recalling Atropine Sulfate 0.01% ophthalmic solution because the filters used to produce the products were recalled, raising concerns about sterility.
Product
Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0023-2017·2016-10-19
Teva Recalls Amikacin Sulfate Injection Due to Manufacturing Deviations
Teva Pharmaceuticals USA is voluntarily recalling 27,547 vials of Amikacin Sulfate Injection due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.
Product
Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0091-2017·2016-10-19
Pharmedium Recalls Lidocaine Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 4,400 syringes of lidocaine HCl 1% because stability data does not support the expiration dates, posing a risk of reduced potency.
Product
lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a syringe, Rx only, PharMEDium, Product code 2R3343.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0073-2017·2016-10-19
Pharmedium Recalls Midazolam Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 1,700 syringes of midazolam HCl because stability data does not support the expiration dates, posing a risk of reduced potency.
Product
midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3196.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0080-2017·2016-10-19
Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 545 syringes of morphine sulfate because stability data does not support the expiration dates, posing a risk of reduced potency.
Product
morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3353.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0093-2017·2016-10-19
Pharmedium Recalls Subpotent Fentanyl Citrate Syringes Nationwide
Pharmedium Services, LLC is recalling 500 syringes of fentanyl citrate due to confirmed subpotency. The product was distributed nationwide.
Product
fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0015-2017·2016-10-19
Leiter's Compounding Recalls Mitomycin Injection Due to Sterility Concerns
Leiter's Compounding is recalling Mitomycin 0.02% injections because the filters used to produce them were recalled, raising concerns about sterility.
Product
Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0078-2017·2016-10-19
Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 592 syringes of morphine sulfate because stability data does not support the expiry date, posing a risk of loss of potency.
Product
morphine Sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3181.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0069-2017·2016-10-19
Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 3,159 syringes of lidocaine HCl 2% because stability data does not support the expiry date, posing a risk of reduced potency.
Product
lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3450.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0039-2017·2016-10-19
Pharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency
Pharmedium Services, LLC is recalling 1,522 syringes of fentanyl citrate because stability data does not support the expiration dates, posing a risk of reduced drug potency.
Product
fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3318.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0012-2017·2016-10-19
Leiter's Compounding Recalls Cefuroxime Sodium Injection Due to Sterility Concerns
Leiter's Compounding is recalling Cefuroxime Sodium Injection because products were made with recalled filters, raising sterility concerns.
Product
Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0017-2017·2016-10-19
Leiter's Compounds Recalls Prednisolone Placebo Due to Sterility Concerns
Leiter's Compounding is recalling placebo ophthalmic suspensions because they were produced using recalled filters, raising concerns about sterility.
Product
Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0025-2017·2016-10-19
Pharmedium Recalls Atropine Sulfate Injection Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 4,407 syringes of atropine sulfate injection nationwide because stability data does not support the expiration dates, posing a risk of reduced drug potency.
Product
atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3324.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0085-2017·2016-10-19
Pharmedium Recalls Phenylephrine Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 380 syringes of Phenylephrine HCl because stability data does not support the expiry date, posing a potential loss of potency.
Product
PHENYLephrine HCl, 40 mcg per mL, 200 mcg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3376.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0038-2017·2016-10-19
Pharmedium Recalls Fentanyl Citrate Injection Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 997 syringes of fentanyl citrate injection because stability data does not support the expiry date, posing a potential loss of potency.
Product
fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3306.
Category
Drug
Distribution
Distributed nationwide

How to read this listing

Filters

11326–11350 of 17785