FDA Recall
Terminated
Historical recordClass II
Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02) and b)18 fl. oz./550 ml Pump Bottles (NDC 30775-040-18), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
by Parker Laboratories, Inc.
- Reason
- CGMP Deviations
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-617-08
by Aurobindo Pharma USA Inc.
- Reason
- cGMP deviations: Batch was released prior to approval.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-616-08
by Aurobindo Pharma USA Inc.
- Reason
- cGMP deviations: Batch was released prior to approval.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Bickel's Snack Foods Inc
- Product
- Butter Flavored Popcorn Naturally & Artificially Flavored, 8…
- Reason
- Undeclared milk
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Inmar Supply Chain Solutions, LLC
- Product
- Multiple FDA-regulated products. Pallets
- Reason
- Potential exposure to rodents and rodent activity in the warehouse.
- Published
- August 30, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05
by ALEMBIC PHARMACEUTICALS, INC.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- August 23, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator Appllications USA, Inc., 57 E. Willow Street NJ 07041, Milburn, USA, NDC 69488-010-61
by Advanced Accelerator Applications USA, Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
- Published
- August 23, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluoride ion), NET WT 4.2 OZ (119 g), Distributed by Hello Products LLC, Montclair, NJ 07042, UPC 8 19156 02026 4 (carton), 12-count case GTIN: 20819156020268; strawberry tubes also sold in Strawberry 3-pack overwrap UPC 8 19156 02349 4, UPC 10819156023491 case; in the variety 3-pack of Strawberry + Unicorn + Grape UPC 8 19156 02332 6, UPC 10819156023323 case; and in a 24-count Toothpaste Floorstand, UPC 819156020684 (case).
by Colgate Palmolive Company
- Reason
- Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were incorrectly filled in tubes labeled as hello fresh watermelon fluoride free toothpaste.
- Published
- August 23, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Out of Specification result observed in content uniformity testing
- Published
- August 16, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
ONO LLC
- Product
- ONO Vegan Blueberry Muffin Protein Overnight Oats, 2.75oz. U…
- Reason
- Undeclared milk
- Published
- August 16, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Cava Foods LLC
- Product
- Cava Spicy Hummus UPC 89832800227 Net Wt. 8oz./226.8 g Pack…
- Reason
- Undeclared sesame
- Published
- August 16, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Betty Lou's Inc
- Product
- Betty Lou's Paleo Java Nuts About Energy Balls with Cacao, C…
- Reason
- Undeclared sesame. Paleo Java Nuts About Energy Balls with Cacao, Coffee & Pumpkin Seeds product containing sesame was packaged and labeled with Paleo Java Nuts About Energy Balls with Cacao, Coffee & Pumpkin Seeds labels that did not declare sesame.
- Published
- August 16, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
by Central Admixture Pharmacy Services Inc
- Reason
- Lack of assurance of sterility: Lack of validation data for sanitization cycles
- Published
- August 9, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
rocuronium, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1
by Central Admixture Pharmacy Services Inc
- Reason
- Lack of assurance of sterility: Lack of validation data for sanitization cycles
- Published
- August 9, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
by Central Admixture Pharmacy Services Inc
- Reason
- Lack of assurance of sterility: Lack of validation data for sanitization cycles
- Published
- August 9, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2
by Central Admixture Pharmacy Services Inc
- Reason
- Lack of assurance of sterility: Lack of validation data for sanitization cycles
- Published
- August 9, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
by Central Admixture Pharmacy Services Inc
- Reason
- Lack of assurance of sterility: Lack of validation data for sanitization cycles
- Published
- August 9, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
morphine in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2040-3
by Central Admixture Pharmacy Services Inc
- Reason
- Lack of assurance of sterility: Lack of validation data for sanitization cycles
- Published
- August 9, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-7
by Central Admixture Pharmacy Services Inc
- Reason
- Lack of assurance of sterility: Lack of validation data for sanitization cycles
- Published
- August 9, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HYDROmorphone in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2012-1
by Central Admixture Pharmacy Services Inc
- Reason
- Lack of assurance of sterility: Lack of validation data for sanitization cycles
- Published
- August 9, 2023
- 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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