FDA Recall
Ongoing
Historical recordClass III
Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
by Contract Pharmaceuticals Limited Canada
- Reason
- Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
- Published
- March 13, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42
by Denver Solutions, LLC DBA Leiters Health
- Reason
- Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- Published
- March 6, 2024
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471
by Seatex LLC
- Reason
- CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033
by Seatex LLC
- Reason
- CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033
by Seatex LLC
- Reason
- CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471
by Seatex LLC
- Reason
- CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471.
by Seatex LLC
- Reason
- CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Rx Only, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, NDC 68682-991-30.
by Bausch Health Companies, Inc.
- Reason
- Subpotent Drug: Out of specification for assay
- Published
- March 6, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, Inc., Fairfield, NJ 07004, NDC 71406-124-35, UPC 371406124356
by Brassica Pharma Pvt Ltd
- Reason
- Lack of Assurance of Sterility
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 76168-707-35, UPC 050428634141
by Brassica Pharma Pvt Ltd
- Reason
- Lack of Assurance of Sterility
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-028-35, UPC 681131395304
by Brassica Pharma Pvt Ltd
- Reason
- Lack of Assurance of Sterility
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-026-35, UPC 681131395298
by Brassica Pharma Pvt Ltd
- Reason
- Lack of Assurance of Sterility
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Dissolution Specifications: Out of specification for dissolution.
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-15
by Golden State Medical Supply Inc.
- Reason
- CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- The recalled Reser's Amish Macaroni Salad was packaged in a…
- Reason
- Undeclared Wheat. The recalled Reser's Amish Macaroni Salad was packaged in a plastic container where the top lid is correctly labeled as Reser s Amish Macaroni Salad but the container side label mis-labeled as Reser s Southern Style with Egg Potato Salad. The ingredient statement on the Reser s Southern Style with Egg Potato Salad container side label does not declare wheat.
- Published
- March 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01
by Micro Labs Limited
- Reason
- CGMP Deviations: Out of specification for residual solvents.
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807 USA, Manufactured by: Bausch Health Companies, Inc. Laval Quebec H7L 448, Canada, NDC 0187-0006-25.
by MCKESSON CORPORATION
- Reason
- CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass I
TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 UPC 3 63736 81961 3
by Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
- Reason
- Chemical Contamination; presence of benzene.
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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