FDA Recall
Terminated
Historical recordClass II
ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12
by PharMEDium Services, LLC
- Reason
- Firm is recalling 46 lots of various products because of a lack of sterility assurance.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02
by Akorn Inc
- Reason
- Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
- Published
- April 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Defective Container: Recall is due to breaking and shattering of ampules upon opening
- Published
- April 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01
by Lupin Pharmaceuticals Inc.
- Reason
- Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
- Published
- April 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
New Capstone, Inc
- Product
- ReStructure VANILLA PROTEIN POWDER NET WT. 527G POUCH & 27G…
- Reason
- The firm was notified that the labeling does not include the word milk on the ingredient statement
- Published
- April 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot # R53074) Co-packaged Batch/Lot # 0198FR & 3188FRB
by Glaxosmithkline Consumer Healthcare Holdings
- Reason
- Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
- Published
- April 1, 2020
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA
by Glaxosmithkline Consumer Healthcare Holdings
- Reason
- Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
- Published
- April 1, 2020
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)
by Glaxosmithkline Consumer Healthcare Holdings
- Reason
- Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
- Published
- April 1, 2020
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95
by Glaxosmithkline Consumer Healthcare Holdings
- Reason
- Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
- Published
- April 1, 2020
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, item # F00573019620C, 20 ct. blister NDC 0573-0196-10, item # F00573019610R, 10 ct. blister
by Glaxosmithkline Consumer Healthcare Holdings
- Reason
- Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
- Published
- April 1, 2020
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.
by PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Reason
- SubPotent Drug: Low out-of-specification results for assay testing.
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01
by Mylan Pharmaceuticals Inc.
- Reason
- Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by Energique, Inc., 201 Apple Blvd., Woodbine, IA 51579, NDC 44911-0411-1
by Grato Holdings, Inc.
- Reason
- Labeling mix-up - Indications on product label are incorrect.
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Organic By Nature, Inc.
- Product
- Touchstone Essentials Organic Super Protein Vanilla Coconut…
- Reason
- Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Organic By Nature, Inc.
- Product
- Touchstone Essentials Super Greens Juice - Raspberry Apple;…
- Reason
- Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Organic By Nature, Inc.
- Product
- Pure Planet Organic Parasite Cleanse; Net Wt. 174g Glass Ja…
- Reason
- Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Organic By Nature, Inc.
- Product
- Springboard Green Power, Dietary Supplement; 240g Plastic B…
- Reason
- Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Organic By Nature, Inc.
- Product
- RAWr! Life Organic Superfoods; Dietary Supplement; 300g Pla…
- Reason
- Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Organic By Nature, Inc.
- Product
- L.O.V.E. Supermeal Vanilla Chai: 1320g Plastic Bottle, 660…
- Reason
- Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop
- Published
- April 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Organic By Nature, Inc.
- Product
- L.O.V.E. Supermeal Original: 420g Plastic Bottle, 1396g Pla…
- Reason
- Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop
- Published
- April 1, 2020
- 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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