FDA Recall
Terminated
Historical recordClass II
Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC 30775-052-03) and b) 4 fl. oz. tube (NDC 30775-052-04) 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
Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl. oz. tubes (NDC 30775-051-04), d) 12 fl oz pump bottles (NDC 30775-051-12), e) 32 fl. oz. pump bottles (NDC 30775-051-32), f) 1 U.S. gallon with pump (NDC 30775-051-50), g) Starter Kit (NDC 30775-051-95), 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
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
🇺🇸 United States
Ongoing
Historical recordClass II
G.O. Corporation
- Product
- Lett. Salad Shred Mix w/Rom, Produce Code 458009, 4-5 lb. b…
- Reason
- Romaine lettuce may be contaminated with deer feces.
- Published
- August 23, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
G.O. Corporation
- Product
- Lettuce Romaine All American, packaged in the following size…
- Reason
- Romaine lettuce may be contaminated with deer feces.
- Published
- August 23, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
G.O. Corporation
- Product
- Lettuce Rom Blend 50/50, packaged in the following sizes and…
- Reason
- Romaine lettuce may be contaminated with deer feces.
- Published
- August 23, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
G.O. Corporation
- Product
- Lett. Blend Rom/End/Rad-All Seasons packaged in the followin…
- Reason
- Romaine lettuce may be contaminated with deer feces.
- Published
- August 23, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
G.O. Corporation
- Product
- Lettuce Salad Blend Monterey, Produce Code 404709, 4-5lb. ba…
- Reason
- Romaine lettuce may be contaminated with deer feces.
- Published
- August 23, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
G.O. Corporation
- Product
- Romaine lettuce packaged into the following configurations a…
- Reason
- Romaine lettuce may be contaminated with deer feces.
- Published
- August 23, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
G.O. Corporation
- Product
- Lettuce Romaine 80/20 GB, packaged in the following sizes an…
- Reason
- Romaine lettuce may be contaminated with deer feces.
- Published
- August 23, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
G.O. Corporation
- Product
- Lettuce Mix w 20 Romaine, Produce Code 421009, 4-5 lb. bags…
- Reason
- Romaine lettuce may be contaminated with deer feces.
- Published
- August 23, 2023
- Distribution
- Multiple states
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 →
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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