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

3451–3475 of 11819

SevereFDA (Drugs)·D-0234-2021·2021-01-27
Complete Pharmacy Recalls Human Chorionic Gonadotropin Due to Potency Testing Deviations
Complete Pharmacy and Medical Solutions is recalling 1,182 vials of Human Chorionic Gonadotropin because the product lacked required potency testing.
Product
HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0236-2021·2021-01-27
Complete Pharmacy Recalls Human Chorionic Gonadotropin Due to Lack of Potency Testing
Complete Pharmacy and Medical Solutions is recalling 1,144 vials of Human Chorionic Gonadotropin 5,000 IU because the product lacked required potency testing.
Product
HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0222-2021·2021-01-20
Paroex Oral Rinse Recalled for Potential Bacterial Contamination
Sunstar Americas is recalling Paroex Oral Rinse due to potential Burkholderia cepacia complex contamination and manufacturing facility violations.
Product
Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0226-2021·2021-01-20
Edge Pharma Recalls Methotrexate Syringes Due to Sterility Testing Concerns
Edge Pharma, LLC is recalling 71 syringes of Methotrexate USP Sterile Solution for Injection because the media used for post-compounding sterility testing was expired.
Product
Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0227-2021·2021-01-20
Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
Nostrum Laboratories is recalling Metformin Hydrochloride Extended-Release Tablets, 750 mg, because the product contains N-Nitrosodimethylamine (NDMA) above acceptable intake levels.
Product
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0207-2021·2021-01-13
SCA Pharmaceuticals Recalls Sodium Citrate Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 5,990 syringes of Sodium Citrate 4% Anticoagulation Solution due to a lack of assurance of sterility and potential defective caps.
Product
Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0198-2021·2021-01-13
SCA Pharmaceuticals Recalls Labetalol HCl Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 9,057 syringes of labetalol HCl injection due to a lack of assurance of sterility and potential defective syringe caps.
Product
labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0211-2021·2021-01-13
SCA Pharmaceuticals Recalls Rocuronium Br Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 13,096 syringes of Rocuronium Br 50 mg/5mL due to a lack of assurance of sterility and potential defective caps.
Product
Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 and b) 5 mL Single Dose Syringe White Label (barcode 70004085028), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0205-2021·2021-01-13
SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 7,890 syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.
Product
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081612
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0209-2021·2021-01-13
SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 116 Morphine Sulfate syringes due to a lack of assurance of sterility and potential defective caps.
Product
Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0185-2021·2021-01-13
Ascend Recalls Cephalexin Oral Suspension Due to Unidentified Impurities
Ascend Laboratories is recalling Cephalexin for Oral Suspension because unidentified impurities were found in specific lots.
Product
CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0176-2021·2021-01-13
Merck Recalls Zerbaxa Injection Vials Due to Sterility Test Failures
Merck Sharp & Dohme is recalling 106,503 vials of Zerbaxa (ceftolozane and tazobactam) injection because sterility tests on related batches failed.
Product
ZERBAXA — ZERBAXA (CEFTOLOZANE AND TAZOBACTAM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0190-2021·2021-01-13
SCA Pharmaceuticals Recalls Esmolol Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 952 syringes of Esmolol HCl 100 mg/10 mL due to a lack of assurance of sterility and potential defective caps.
Product
Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004062012
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0195-2021·2021-01-13
SCA Pharmaceuticals Recalls Hydromorphone Injection Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 3,092 syringes of Hydromorphone HCl injection due to a lack of assurance of sterility and potential defective syringe caps.
Product
HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0197-2021·2021-01-13
SCA Pharmaceuticals Recalls Ketamine Injection Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 11,075 syringes of Ketamine 100 mg/10mL injection due to a lack of assurance of sterility and potential defective syringe caps.
Product
Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0204-2021·2021-01-13
SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 23,029 syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.
Product
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081012
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0194-2021·2021-01-13
SCA Pharmaceuticals Recalls Glycopyrrolate Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 1,614 syringes of Glycopyrrolate 1 mg/5mL due to a lack of assurance of sterility and potential defective caps.
Product
Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0214-2021·2021-01-13
SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 6,710 fentanyl syringes distributed to hospitals nationwide due to a lack of assurance of sterility and potential defective caps.
Product
fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0192-2021·2021-01-13
SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 996 fentanyl and bupivacaine syringes due to a lack of assurance of sterility and potential defective caps.
Product
fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0193-2021·2021-01-13
SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling fentanyl syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.
Product
fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004020016
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0213-2021·2021-01-13
SCA Pharmaceuticals Recalls ePHEDrine Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling ePHEDrine 25 mg/5 mL Injection syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.
Product
ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0203-2021·2021-01-13
SCA Pharmaceuticals Recalls Neostigmine Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 390 syringes of neostigmine methylsulfate due to a lack of assurance of sterility and potential defective caps.
Product
neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004075009
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0206-2021·2021-01-13
SCA Pharmaceuticals Recalls Rocuronium Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 7,940 syringes of Rocuronium Br 100 mg/10mL because defective caps may compromise sterility. The product was distributed to hospitals nationwide.
Product
Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR, 72205, barcode 70004085012
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0210-2021·2021-01-13
SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 14,580 syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.
Product
PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0187-2021·2021-01-13
SCA Pharmaceuticals Recalls Buffered Lidocaine Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 3,793 syringes of Buffered Lidocaine HCl due to a potential defective cap that compromises sterility. The product was distributed to hospitals nationwide.
Product
Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic Use, 5 mL Single Dose Syringe, Rx Only SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072509
Category
Drug
Distribution
Distributed nationwide

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3451–3475 of 11819