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
Teva Pharmaceuticals Usa, Inc
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg st...
Injectable Drugs·2,200 affected·Apr 24, 2026
High RiskFDA
Thea Pharma, Inc.
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Wal...
Ophthalmic Drugs·0 affected·Apr 23, 2026
High RiskFDA
Thea Pharma, Inc.
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02...
Ophthalmic Drugs·0 affected·Apr 23, 2026
High RiskFDA
Scope Health
Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th F...
Drugs·0 affected·Apr 20, 2026
High RiskFDA
Harrow Eye Llc
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Drugs·50,900 affected·Apr 17, 2026
High RiskFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2...
Drugs·43,225 affected·Apr 6, 2026
High RiskFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, ...
Drugs·37,215 affected·Apr 6, 2026
High RiskFDA
Depuy (ireland)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
Medical Devices·3 affected·Apr 3, 2026
High RiskFDA
Depuy (ireland)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
Medical Devices·3 affected·Apr 3, 2026
High RiskFDA
Depuy (ireland)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
Medical Devices·3 affected·Apr 3, 2026
High RiskFDA
Depuy (ireland)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
Medical Devices·3 affected·Apr 3, 2026
High RiskFDA
Depuy (ireland)
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
Medical Devices·3 affected·Apr 3, 2026
High RiskFDA
B Braun Medical Inc
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
Injectable Drugs·17,124 affected·Apr 2, 2026
High RiskFDA
B Braun Medical Inc
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
Drugs·54,540 affected·Apr 2, 2026
High RiskFDA
Huons Co., Ltd.
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, L...
Injectable Drugs·7,120,750 affected·Apr 2, 2026
High RiskFDA
Huons Co., Ltd.
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., L...
Injectable Drugs·3,260,170 affected·Apr 2, 2026
High RiskFDA
B Braun Medical Inc
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-73...
Drugs·124,244 affected·Apr 2, 2026
High RiskFDA
Huons Co., Ltd.
Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do,...
Injectable Drugs·33,599,925 affected·Apr 2, 2026
High RiskFDA
B Braun Medical Inc
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264...
Injectable Drugs·24,928 affected·Apr 2, 2026
High RiskFDA
Huons Co., Ltd.
Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valle...
Injectable Drugs·0 affected·Apr 2, 2026
High RiskFDA
Merit Medical Systems, Inc.
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Medical Devices·0 affected·Apr 2, 2026
High RiskFDA
International Medication Systems Ltd.
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphast...
Injectable Drugs·81,520 affected·Apr 1, 2026
High RiskFDA
Preferred Pharmaceuticals, Inc.
Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Broo...
Ophthalmic Drugs·720 affected·Mar 25, 2026
High RiskFDA
Fagron Compounding Services
Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 6722...
Injectable Drugs·16,130 affected·Mar 20, 2026
High RiskFDA
Fagron Compounding Services
Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 672...
Injectable Drugs·34,260 affected·Mar 20, 2026
High RiskFDA
Fagron Compounding Services
norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226...
Injectable Drugs·5,140 affected·Mar 20, 2026
High RiskFDA
Fagron Compounding Services
norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226,...
Injectable Drugs·25,260 affected·Mar 20, 2026
High RiskFDA
Fagron Compounding Services
Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, ...
Injectable Drugs·11,680 affected·Mar 20, 2026
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured i...
Injectable Drugs·19,869 affected·Mar 17, 2026
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured i...
Injectable Drugs·1,897 affected·Mar 17, 2026
High RiskFDA
Nephron Sc, Llc
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing fa...
Drugs·146,280 affected·Mar 17, 2026
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured i...
Injectable Drugs·21,930 affected·Mar 17, 2026
High RiskFDA
Chiesi Usa, Inc.
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510...
Drugs·7,235 affected·Mar 17, 2026
High RiskFDA
Surgismoke Solutions
Flamingo Funnel Small, Model Number SQ20012-01
Medical Devices·2,505 affected·Mar 16, 2026
High RiskFDA
Surgismoke Solutions
Flamingo Funnel Medium, Model Number SQ20012-02
Medical Devices·2,505 affected·Mar 16, 2026
High RiskFDA
Medline Industries, Lp
CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
Medical Devices·640 affected·Mar 16, 2026
High RiskFDA
Cipla Usa, Inc.
Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen Internatio...
Injectable Drugs·0 affected·Mar 13, 2026
High RiskFDA
Cipla Usa, Inc.
Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: ...
Injectable Drugs·54,583 affected·Mar 13, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LL...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi US...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: ...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA,...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LL...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson a...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Uni...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), ...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Uni...
Injectable Drugs·0 affected·Mar 11, 2026
High RiskFDA
Fresenius Kabi Usa, Llc
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medic...
Injectable Drugs·0 affected·Mar 11, 2026