FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Progressive Laboratories, Inc
- Product
- Thyroid Resilience 120 count bottle packaged in an amber pla…
- Reason
- Recalled dietary supplements may contain undeclared milk.
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Progressive Laboratories, Inc
- Product
- Testosterzone 180 count bottle packaged in an amber plastic…
- Reason
- Recalled dietary supplements may contain undeclared milk.
- Published
- March 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 11788, NDC 63739-489-10
by Mckesson Packaging Services
- Reason
- Failed Stability Specifications
- Published
- March 14, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP Wilmington, DE 19850 by: Patheon Pharmaceuticals, Inc. Cincinnati OH 45237 Product of Switzerland NDC 0310-0657-58
by AstraZeneca Pharmaceuticals LP
- Reason
- Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
- Published
- March 14, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10
by Osmotica Pharmaceutical Corp
- Reason
- Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
- Published
- March 14, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05
by Akorn, Inc.
- Reason
- Failed Stability Specification: OOS low viscosity results discovered during retain testing.
- Published
- March 14, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-25.
by Hospira Inc. A Pfizer Company
- Reason
- Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
- Published
- March 14, 2018
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Lotte International America Corp.
- Product
- Lotte Kancho Choco-Biscuit; Sold as Lotte Kancho - 42 g…
- Reason
- Firm was notified by customer of peanut allergen found in the product during product sampling and testing in Kancho Choco Biscuits.
- Published
- March 14, 2018
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Snyder's-Lance Inc.
- Product
- Emerald brand Glazed Walnuts; Net WT. 6.5 OZ; Re-sealable po…
- Reason
- Snyder's Lance is voluntarily recalling 6.5 oz. Emerald brand walnuts due to the presence of undeclared peanuts, almonds, cashews, and pecans.
- Published
- March 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Get The Tea
- Product
- Life Change Fat Burner, 90 Gel Caps!, Burn Fat!, Remove fat…
- Reason
- Get The Tea is notifying customers that Life Change Fat Burners contain soy.
- Published
- March 14, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810 Manufactured for: Aurobindo Pharma Limited IDA, Pashamylaram - 502307, India ---- NDC 55150-243-46
by AuroMedics Pharma LLC
- Reason
- Presence of Particulate Matter; contains visible particulate matter identified as mold.
- Published
- March 7, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by Geri-Care Pharmaceuticals Corp., Brooklyn, NY 11204, NDC 57896-0186-04
by Kareway Products Inc
- Reason
- Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
- Published
- March 7, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01, NDC 0264-2201-00.
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
- Published
- March 7, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120
by Fagron, Inc
- Reason
- Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
- Published
- March 7, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industries, Inc., Northfield, IL 60093; Product Number MDS093945; NDC 53329-938-04
by Medline Industries Inc
- Reason
- Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
- Published
- March 7, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC 52544-931-07), b) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, Manufactured by: Patheon Italia S.p.A. Ferentino, Italy 03013.
by ALLERGAN
- Reason
- Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
- Published
- March 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478
by Apace KY LLC
- Reason
- Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
- Published
- March 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Seggiano Usa Inc.
- Product
- Seggiano Artichoke & Garlic Sauce & Spread Net Weight 200g,…
- Reason
- The Tuscan Kale Pesto was mislabeled as Seggiano Artichoke & Garlic Sauce & Spread and therefore, contains undeclared cashews.
- Published
- March 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Bell Plantation Inc.
- Product
- Ready-to-Eat Powdered Peanut Butter in 1 lb (16 oz.) plastic…
- Reason
- Analytical results for generic non-pathogenic E. coli surpassed firm's in-house specifications for finished product..
- Published
- March 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC 58597-8276-3), c) 25g (NDC 58597-8276-4), d) 100g (NDC 58597-8276-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
by American Pharmaceutical Ingredients LLC
- Reason
- CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- Published
- February 28, 2018
- 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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