Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
High RiskFDA
Downing Labs, Llc
Methylcobalamin Injection Buffered 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-...
Injectable Drugs·315 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ...
Injectable Drugs·2,189 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
DMSO 99% Injection, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Injectable Drugs·187 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Thiamine HCl Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Injectable Drugs·72 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
MICML TRNDPPC Injection (Preserved) 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Injectable Drugs·502 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Green Tea (EGCG) Injectable, 10mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Injectable Drugs·23 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
DMAE Dimethylaminoethanol Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-...
Injectable Drugs·16 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Co-Enzyme Q-10 Injectable, 20mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Injectable Drugs·12 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Potassium Chloride Injection (20mEq/10mL), 2mEq/ML, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1...
Injectable Drugs·225 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
TNPDR Injection Buffered, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Injectable Drugs·481 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Magnesium Sulfate Injectable, 14.28%, 7mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Injectable Drugs·160 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Pyridoxine Injection, 100 mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Injectable Drugs·280 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
EDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Injectable Drugs·2,279 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-9...
Injectable Drugs·74 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Magnesium Sulfate Injection (4060mOsm/L), 50%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-...
Injectable Drugs·304 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
EDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914...
Injectable Drugs·104 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Piracetam Injection, 200mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Injectable Drugs·28 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
L-Glutamine Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Injectable Drugs·14 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Methylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30mL Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dall...
Injectable Drugs·363 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Magnesium Chloride Hexahydrate Injection 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-...
Injectable Drugs·289 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
L-Tyrosine Injectable, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Injectable Drugs·29 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Hydroxocobalamin Injection (Buffered) 1mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-9...
Injectable Drugs·106 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Vitamin D3 Injectable, 10,000 U/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Injectable Drugs·27 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)100mL vials, Rx only, Downing Labs, LLC 4001 McEwen Rd, Su...
Injectable Drugs·4,857 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Calcium Gluconate (680mOsm/L) Injection 10%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-91...
Injectable Drugs·286 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
M.I.C Injection (Preserved), 25/50/25mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914...
Injectable Drugs·172 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Dexpanthenol Injection, 250mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Injectable Drugs·235 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914...
Injectable Drugs·20 affected·Oct 16, 2015
High RiskFDA
Downing Labs, Llc
Chromium Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Injectable Drugs·30 affected·Oct 16, 2015
High RiskFDA
Tz Medical Inc.
SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverSt...
Surgical Devices·10,180 affected·Oct 14, 2015
High RiskFDA
Chen Shwezin, Inc. Dba Park Compounding Pharmacy
TRI-MIX 20MCG+0.5MG+15MG/ML, 10 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (...
Drugs·2 affected·Oct 6, 2015
High RiskFDA
Chen Shwezin, Inc. Dba Park Compounding Pharmacy
METHYLCOBALAMIN 1000MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (80...
Drugs·2 affected·Oct 6, 2015
High RiskFDA
Chen Shwezin, Inc. Dba Park Compounding Pharmacy
CAFFEINE + SODIUM BENZOATE 500MG/ML, 35 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA ...
Drugs·2 affected·Oct 6, 2015
High RiskFDA
Chen Shwezin, Inc. Dba Park Compounding Pharmacy
PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (...
Drugs·2 affected·Oct 6, 2015
High RiskFDA
Chen Shwezin, Inc. Dba Park Compounding Pharmacy
TRI-MIX 10MCG+0.5MG+15MG/ML,5 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (80...
Drugs·2 affected·Oct 6, 2015
High RiskFDA
Baxter Healthcare Corp.
Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
Medical Devices·19,440 affected·Oct 6, 2015
High RiskFDA
Diabetes Corporation Of America Dba Dca Pharmacy
Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Fra...
Injectable Drugs·129 affected·Sep 23, 2015
High RiskFDA
Ethicon Endo-surgery Inc
HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue ...
Medical Devices·441,490 affected·Sep 23, 2015
High RiskFDA
Bedford Pharmacy
P-P-P (COBAL) 30-1-5/mL, Injection,Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Injectable Drugs·1 affected·Sep 22, 2015
High RiskFDA
Bedford Pharmacy
Acetylcysteine 10% Opthalmic Solution, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Drugs·2 affected·Sep 22, 2015
High RiskFDA
Bedford Pharmacy
Methylcobalamin (Bacteriostatic) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Injectable Drugs·1 affected·Sep 22, 2015
High RiskFDA
Bedford Pharmacy
Testosterone Cypionate (Complete Formula) 100 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Injectable Drugs·3 affected·Sep 22, 2015
High RiskFDA
Bedford Pharmacy
Testosterone Cypionate (Complete Formula) 200 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Injectable Drugs·2 affected·Sep 22, 2015
High RiskFDA
Bedford Pharmacy
P-P (COBAL) 30-2 /mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Injectable Drugs·4 affected·Sep 22, 2015
High RiskFDA
Bedford Pharmacy
P-P-P (COBAL) 30-4-40/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Injectable Drugs·1 affected·Sep 22, 2015
High RiskFDA
Bedford Pharmacy
P-P-P (COBAL) 30-1-20/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Injectable Drugs·4 affected·Sep 22, 2015
High RiskFDA
Bedford Pharmacy
Methylcobalamin (preservative Free) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Injectable Drugs·1 affected·Sep 22, 2015
High RiskFDA
Bedford Pharmacy
P-P-P (COBAL) 30-2- 30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Injectable Drugs·1 affected·Sep 22, 2015