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

14876–14900 of 17799

SevereFDA (Drugs)·D-1528-2014·2014-08-13
B Complex Injection Recalled for Lack of FDA Approval
Medical Supply Liquidators LLC is recalling B Complex for Injection USP with Methylcobalamin because it was marketed without an approved NDA/ANDA and the manufacturer is not FDA-registered.
Product
B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ use, multiple dose vial, packaged in 10 ml vials and 30 ml vials. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1521-2014·2014-08-13
BCAA 4% Injection Recalled for Lack of FDA Approval
Medical Supply Liquidators LLC is recalling BCAA 4% Branched Chain Amino Acid Injection USP because it was marketed without an approved NDA/ANDA and the manufacturer is not FDA-registered.
Product
BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1526-2014·2014-08-13
Unapproved Injectable B Complex Recall Due to Unregistered Manufacturer
Medical Supply Liquidators LLC is recalling Super MIC B Complex injections because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.
Product
Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1530-2014·2014-08-13
FDA Recalls Unapproved Lipo 8 Injection Vials Due to Unregistered Manufacturer
Medical Supply Liquidators LLC is recalling Lipo 8 Injection USP 200 mg/ml vials because the manufacturer is not registered with the FDA and the product lacks an approved NDA/ANDA.
Product
Lipo 8 Injection USP 200 mg/ml, packaged in 30 ml vials, Sterile, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1515-2014·2014-08-13
Sandoz Alprazolam Tablets Recalled for Stainless Steel Metal Particulates
Mckesson Packaging Services is recalling Sandoz Alprazolam Tablets 0.25 mg due to the presence of stainless steel metal particulates.
Product
Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: Sandoz, Inc., Princeton, NJ 08540 --- NDC 63739-644-10
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-1511-2014·2014-08-13
Caraco Recalls Cephalexin Capsules Due to Manufacturing Practice Deviations
Caraco Pharmaceutical Laboratories is recalling Cephalexin Capsules, 500 mg, because they were manufactured with active pharmaceutical ingredients that did not follow good manufacturing practices.
Product
Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1518-2014·2014-08-13
Alcohol-Free Hand Sanitizer Recalled for Microbial Contamination
HLI dba Humphreyline Inc is recalling 975 bottles of alcohol-free hand sanitizer due to microbial contamination. The product was distributed in Kentucky, Maryland, and Virginia.
Product
Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC, contains Benzalkonium chloride. Mfg. for HLI, Portland, OR 97222 NDC: 19392-120-03. Labeled A) Anne Arundel County Mental Health Agency, Inc., B) Family Advocacy Program, and C) Henderson…
Category
Drug
Distribution
3 states
ModerateFDA (Drugs)·D-1533-2014·2014-08-13
FDA Recalls Unapproved Glutathione Injection Vials Nationwide and Abroad
Medical Supply Liquidators LLC is recalling Glutathione Injection USP vials because the manufacturer is not FDA-registered and the product lacks an approved NDA or ANDA.
Product
Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1519-2014·2014-08-13
FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer
Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin injections because the manufacturer is not registered with the FDA and the product lacks an approved NDA/ANDA.
Product
Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1520-1014·2014-08-13
FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer
Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin Injections because the manufacturer is not registered with the FDA and the product lacks an approved NDA or ANDA.
Product
Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1522-2014·2014-08-13
FDA Recalls Unapproved Vitamin B12 Injection Vials Nationwide
Medical Supply Liquidators LLC is recalling Vitamin B12 Cyanocobalamin Injection vials because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.
Product
Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1513-2014·2014-08-13
Wockhardt Recalls BuPROPion HCl Extended-Release Tablets Due to Impurity Levels
Wockhardt USA is recalling 840 bottles of buPROPion HCl Extended-Release Tablets because out-of-specification levels of the impurity m-chlorobenzoic acid were observed.
Product
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1510-2014·2014-08-13
Caraco Recalls Cephalexin Capsules Due to Manufacturing Deviations
Caraco Pharmaceutical is recalling Cephalexin Capsules, 250 mg, because the active ingredients were not manufactured with good manufacturing practices.
Product
Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1527-2014·2014-08-13
FDA Recalls Unapproved Vitamin B12 Injection Vials Nationwide and Abroad
Medical Supply Liquidators LLC is recalling Vitamin B12 Cyanocobalamin injections because the manufacturer is not FDA-registered and the product lacks an approved NDA or ANDA.
Product
Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml, packaged in 10 ml vials and 30 ml vials, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1525-2014·2014-08-13
Medical Supply Liquidators Recalls Unapproved MIC Injection Vials
Medical Supply Liquidators LLC is recalling MIC Injection USP vials because the manufacturer is not registered with the FDA and the product lacks an approved NDA/ANDA.
Product
MIC Injection USP, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1517-2014·2014-08-13
SST Corporation Recalls Tetrahydrozoline HCL Due to CGMP Deviations
SST Corporation is recalling Tetrahydrozoline HCL drums because they were stored in a non-GMP compliant warehouse in Italy.
Product
Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5
Category
Drug
Distribution
1 state
LowFDA (Drugs)·D-1516-2014·2014-08-13
Novartis Recalls Cataflam Tablets Due to Illegible Ink Identification
Novartis is recalling 50 bottles of Cataflam (diclofenac potassium) 50 mg tablets because ink identification rubbed off during transit, making them illegible.
Product
Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Canada L1N 5Z5; Distributed by: Novartis Pharmaceuticals Corp., East Hanover, New Jersey 07936; NDC 0078-0436-05, UPC 3 0078-0436-05 2.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1500-2014·2014-08-06
Jubilant Cadista Recalls Losartan Potassium and Hydrochlorothiazide Tablets
Jubilant Cadista Pharmaceuticals is recalling Losartan Potassium and Hydrochlorothiazide tablets due to the presence of stainless steel blemishes.
Product
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1497-2014·2014-08-06
Fagron Recalls Pentravan Base Due to Mold Contamination
Fagron is recalling six lots of Pentravan Base 2.5 Kg due to the presence of mold. The product is used for prescription compounding.
Product
Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrance-free, Manufactured by; Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 NDC 51552-0919-8.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1509-2014·2014-08-06
Sandoz Recalls Alprazolam Tablets Due to Stainless Steel Particulates
Sandoz Incorporated is recalling 1,332 bottles of Alprazolam 0.25mg tablets nationwide because they may contain stainless steel metal particulates.
Product
ALPRAZOLAM — ALPRAZOLAM (ALPRAZOLAM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1496-2014·2014-08-06
Fagron Recalls Phytobase Cream Lots Due to Mold Contamination
Fagron is recalling six lots of Phytobase Cream, a prescription compounding vehicle, due to the presence of mold.
Product
Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil Bodies), Manufactured by Fagron, Inc. 2400 Pilot Knob Rd, St Paul, MN 55120…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1498-2014·2014-08-06
Fagron Recalls Pentravan Plus Base Due to Mold Contamination
Fagron is recalling specific lots of Pentravan Plus Base, a prescription compounding ingredient, because of mold contamination.
Product
Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For prescription compounding, Oil-in-water emulsion base alternative to PLO gel, Added emulsifier ad viscosity-enhancing agent for use with high concentrations of active ingredients.Pre served and…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1487-2014·2014-08-06
Dermamedics Post Procedure Cream Recalled for Lack of FDA Approval
Dermamedics, L.L.C. is recalling Post Procedure Cream because the FDA determined the product is an unapproved new drug and misbranded.
Product
Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1508-2014·2014-08-06
Daiichi Sankyo Recalls Benicar HCT Tablets Due to Temperature Abuse
Daiichi Sankyo is recalling specific lots of Benicar HCT tablets because they were not stored at controlled room temperature during shipping.
Product
Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-107-30 and NDC 65597-107-90
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1483-2014·2014-08-06
McKesson Recalls Aspirin DR Tablets for Dissolution Failure
McKesson Packaging Services is recalling Aspirin DR Enteric Coated Tablets because they failed to meet dissolution specifications at the 12-month time interval.
Product
Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC
Category
Drug
Distribution
Distributed nationwide

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14876–14900 of 17799