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 deaths or serious injuries are reported, 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

8826–8850 of 18015

SevereFDA (Drugs)·D-0467-2019·2019-02-20
Promise Pharmacy Recalls MIC B12 Injection Due to Sterility Concerns
Promise Pharmacy, LLC is recalling MIC B12+L-Carnitine+Chromium injections due to a lack of sterility assurance. The recall covers 64 vials distributed nationwide.
Product
MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium, 25mg/50mg/50mg/1mg/100mg/0.4mcg/ml, 10mL, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0474-2019·2019-02-20
Promise Pharmacy Recalls Procaine HCl Injection Due to Sterility Concerns
Promise Pharmacy, LLC is recalling 11 vials of Procaine HCl 2% injection due to a lack of sterility assurance. The product was distributed nationwide.
Product
Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0443-2019·2019-02-20
Promise Pharmacy Recalls Methylcobalamin Injections Due to Sterility Concerns
Promise Pharmacy, LLC is recalling 704 vials of Methylcobalamin 10,000 mcg Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.
Product
Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0453-2019·2019-02-20
Promise Pharmacy Recalls Ipamorelin Injections Due to Sterility Concerns
Promise Pharmacy is recalling 416 vials of Ipamorelin 9 mg injection because the product lacks sterility assurance. The affected lots were distributed nationwide.
Product
Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0460-2019·2019-02-20
Promise Pharmacy Recalls HCG Injections Due to Sterility Concerns
Promise Pharmacy is recalling 654 vials of HCG injections nationwide due to a lack of sterility assurance.
Product
HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0437-2019·2019-02-20
Promise Pharmacy Recalls Prednisolone and Bromfenac Ophthalmic Solution for Sterility Concerns
Promise Pharmacy is recalling 167 bottles of compounded Prednisolone and Bromfenac Ophthalmic Solution due to a lack of sterility assurance.
Product
Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0439-2019·2019-02-20
Promise Pharmacy Recalls Multi Trace Injection Due to Sterility Concerns
Promise Pharmacy is recalling Multi Trace injection vials because they may lack sterility assurance. The recall covers 30 mL vials distributed nationwide.
Product
Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0458-2019·2019-02-20
Promise Pharmacy Recalls Bremelanotide Injections Due to Sterility Concerns
Promise Pharmacy is recalling 64 vials of Bremelanotide 20mg injections nationwide due to a lack of sterility assurance.
Product
Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0469-2019·2019-02-20
Promise Pharmacy Recalls Niacinamide Injection Due to Sterility Concerns
Promise Pharmacy, LLC is recalling Niacinamide injection, 100mg/mL, 5mL vials due to a lack of sterility assurance. The product was distributed nationwide in the USA.
Product
Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0456-2019·2019-02-20
Promise Pharmacy Recalls IGF-1 LR3 Injections Due to Sterility Concerns
Promise Pharmacy is recalling 59 vials of IGF-1 LR3 injections because they lack sterility assurance. The affected products were distributed nationwide.
Product
IGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0475-2019·2019-02-20
Promise Pharmacy Recalls Pyridoxine HCl Injection Due to Sterility Concerns
Promise Pharmacy, LLC is recalling 8 vials of Pyridoxine HCl Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.
Product
Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0487-2019·2019-02-20
Valeant Recalls Cardizem CD Capsules for Dissolution Failures
Valeant Pharmaceuticals is recalling 1,023 bottles of Cardizem CD (diltiazem hydrochloride) 120 mg capsules because they failed to meet dissolution specifications.
Product
CARDIZEM CD — CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0482-2019·2019-02-20
US Compounding Recalls LET Gel 4% Syringes Due to Missing Lot and Expiration Dates
US Compounding Inc is recalling 1,931 syringes of LET Gel 4% because the labels are missing specific lot and expiration dates.
Product
LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe, Rx only, US Compounding, 1270 Don's Lane, Conway, AR, 800-718-3588, Barcode 62295501303.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0488-2019·2019-02-20
Valeant Recalls Cardizem CD Capsules for Dissolution Failures
Valeant Pharmaceuticals is recalling 206 bottles of Cardizem CD capsules because they failed to meet dissolution specifications, meaning the drug may not release properly.
Product
CARDIZEM CD — CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0999-2019·2019-02-20
Avella Recalls Magnesium Sulfate Bags Due to Incorrect Barcode Expiration Dates
Avella of Deer Valley is recalling 4,950 bags of compounded magnesium sulfate because the 2D barcodes contain incorrect expiration dates that do not match the label.
Product
MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-902-05.
Category
Drug
Distribution
13 states
ModerateFDA (Drugs)·D-0490-2019·2019-02-20
Valeant Recalls Cardizem CD Capsules for Dissolution Failures
Valeant Pharmaceuticals is recalling 22 bottles of Cardizem CD capsules because they failed to meet dissolution specifications, potentially affecting drug release.
Product
CARDIZEM CD — CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0997-2019·2019-02-20
Avella Recalls Labetalol Syringes Due to Incorrect Barcode Expiration Dates
Avella of Deer Valley, Inc. is recalling 2,840 syringes of Labetalol 20mg Injectable Solution because the 2D barcodes contain incorrect expiration dates.
Product
Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use syringe. Repackaged by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-822-71.
Category
Drug
Distribution
13 states
ModerateFDA (Drugs)·D-1000-2019·2019-02-20
Avella recalls magnesium sulfate bags with incorrect barcode expiration dates
Avella of Deer Valley is recalling 8,500 bags of compounded magnesium sulfate because the 2D barcodes contain incorrect expiration dates that do not match the label.
Product
MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Compounded by Avella Specialty Pharmacy 24416 N 19 th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-907-05.
Category
Drug
Distribution
13 states
ModerateFDA (Drugs)·D-0998-2019·2019-02-20
Avella recalls magnesium sulfate bags with incorrect barcode expiration dates
Avella of Deer Valley is recalling 250 bags of compounded magnesium sulfate due to incorrect expiration dates in the 2D barcodes.
Product
MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-901-05.
Category
Drug
Distribution
13 states
ModerateFDA (Drugs)·D-0486-2019·2019-02-20
LGM Pharma Recalls Cidofovir Dihydrate Due to CGMP Deviations
LGM Pharma LLC is recalling Cidofovir Dihydrate because the API manufacturer is on FDA Import Alert for CGMP deviations.
Product
CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP PHARM BEIJING CO., LTD, 12-2-620, Jia 69, Fushi Rd., Haidian, Beijing 100049, China. Batch Number JD-BP-37-20150801
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0489-2019·2019-02-20
Valeant Recalls Cardizem CD Capsules for Dissolution Failures
Valeant Pharmaceuticals is recalling 390 bottles of Cardizem CD capsules because they failed to meet dissolution specifications, potentially affecting drug release.
Product
CARDIZEM CD — CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0484-2019·2019-02-20
Lupin Recalls Moxifloxacin Ophthalmic Solution Due to Stability Test Failures
Lupin Pharmaceuticals is recalling Moxifloxacin Ophthalmic Solution because out-of-specification test results were found in a long-term stability study.
Product
MOXIFLOXACIN — MOXIFLOXACIN (MOXIFLOXACIN)
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-0492-2019·2019-02-20
Oxalis Labs Recalls Clobetasol Propionate Topical Solution Due to Leakage
Oxalis Labs is recalling 53,358 bottles of Clobetasol Propionate Topical Solution due to defective containers and complaints of leakage.
Product
CLOBETASOL PROPIONATE — CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
Category
Drug
Distribution
4 states
LowFDA (Drugs)·D-0483-2019·2019-02-20
Akorn Recalls COSOPT Ophthalmic Solution Due to Stability Failures
Akorn Inc. is recalling 30,794 bottles of COSOPT Ophthalmic Solution because the product failed stability specifications for opalescence.
Product
COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0995-2019·2019-02-20
Dr. Reddy's Recalls Esomeprazole Magnesium Capsules Due to Discoloration
Dr. Reddy's Laboratories is recalling Esomeprazole Magnesium 40mg capsules because they may contain brown pellets.
Product
ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
Category
Drug
Distribution
Distributed nationwide

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8826–8850 of 18015