FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Figi's, Inc
- Product
- Dark Chocolate covered Gingersnaps. Packaged as follows: 1…
- Reason
- Figi's is recalling Gift #0368 Christmas Gingersnap Variety and Bulk Dark Chocolate Gingersnaps due to undeclared milk.
- Published
- January 10, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Rachael's Food Corporation
- Product
- Rachael's SPRINGFIELD SMOKED FISH LOX CREAM CHEESE SPREAD, 8…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- January 10, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Rachael's Food Corporation
- Product
- Boston Salads Scallion Cream Cheese Spread, 5 lbs. and Racha…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- January 10, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Rachael's Food Corporation
- Product
- SPRINGFIELD SMOKED Whitefish Meat, 5 lb bag, UPC: 0450491171…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- January 10, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Rachael's Food Corporation
- Product
- SPRINGFIELD SMOKED FISH Smoked Bluefish, catch weight UPC: 0…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- January 10, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Rachael's Food Corporation
- Product
- Rachael's SPRINGFIELD SMOKED FISH Smoked Trout 6 oz, UPC: 04…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- January 10, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Rachael's Food Corporation
- Product
- SPRINGFIELD SMOKED FISH Smoked Sable, Catch weight, UPC: N/A
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- January 10, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Biopharmaceticals, Inc. One Marina Park Drive, 12th Floor, Boston, MA 02210 USA. NDC 59922-631-01
by Keryx Biopharmaceuticals, Inc.
- Reason
- Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
- Published
- January 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-165-78
by PharMEDium Services, LLC
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp. Date
- Published
- January 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL , For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-455-78
by PharMEDium Services, LLC
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp. Date
- Published
- January 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg per 2 mL), For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-259-28
by PharMEDium Services, LLC
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp. Date
- Published
- January 3, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
All Sterile Products within expiry
by Vital Rx, Inc. dba Atlantic Pharmacy and Compounding
- Reason
- Lack of Assurance of Sterility .
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets per paper carton, Distributed by Perrigo, Allegan, MI 49010, NDC 70085-151-01
by L. Perrigo Company
- Reason
- Microbial Contamination of Non-Sterile Products
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: Claris LifeScience Inc. North Brunswick NJ 08902 by Claris Injectables Ltd. Gujarat, India UPC 336000008242 NDC 36000-008-249
by Claris Lifesciences Inc
- Reason
- Superpotent
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactured For: The Ampt Life, LLC.
by The Ampt Life, LLC
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only, Manufactured by: Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738: Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA, NDC-52544-295-28
by Teva Pharmaceuticals USA
- Reason
- Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India
by Renaissance Lakewood, LLC
- Reason
- Superpotent
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02
by Pfizer Inc.
- Reason
- Presence of Particulate Matter: glass particulate found in vial
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health.
by EZWeightLossTX LLC
- Reason
- Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
- Published
- December 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health.
by EZWeightLossTX LLC
- Reason
- Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
- Published
- December 27, 2017
- 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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