FDA Recall
Terminated
Historical recordClass I
Gaia Kratom (mitragyna speciosa) powder, Ganesh, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
by Gaia Ethnobotanical LLC
- Reason
- Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Gaia Kratom (mitragyna speciosa) powder, Elephant, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
by Gaia Ethnobotanical LLC
- Reason
- Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Gaia Kratom (mitragyna speciosa) powder, Bali Gold, 1oz, 250g 1kg packages, Gaia Ethnobotanical.com
by Gaia Ethnobotanical LLC
- Reason
- Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01
by Mylan Pharmaceuticals Inc.
- Reason
- Subpotent Drug
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11
by LUPIN SOMERSET
- Reason
- Subpotent Drug and Failed Content Uniformity.
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00
by Sanofi-Aventis U.S. LLC
- Reason
- Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea, CA 92821, NDC 42721-112-08.
by Medgyn Products, Inc.
- Reason
- CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.
by Akorn, Inc.
- Reason
- CGMP Deviations
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.
by Wockhardt Limited
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.
by Wockhardt Limited
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Pinnacle Food Group, Llc
- Product
- Wish Bone House Italian Salad Dressing 15 oz.
- Reason
- The recall was initiated after learning from a retail customer that a limited number of bottles were mislabeled. The product contains milk and egg not declared on the bottle.
- Published
- July 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Talking Rain Beverage Co Inc
- Product
- Sparkling ICE Cherry Limeade Naturally Flavored Sparking Wat…
- Reason
- Sparkling ICE Cherry Limeade, 17 oz. bottles, is recalled after the firm received a small number of customer complaints that reported an off-taste and off-odor of the product.
- Published
- July 18, 2018
- Distribution
- Distributed in AL, AR, AZ, CA, CO, CT, F…
View recall →
FDA Recall
Terminated
Historical recordClass I
Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-01.
by Fagron Compounding Services LLC dba Fagron Sterile Services
- Reason
- Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
- Published
- July 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-02.
by Fagron Compounding Services LLC dba Fagron Sterile Services
- Reason
- Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
- Published
- July 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bottle (NDC 49035-312-08), Distributed by: Wal-mart Stores, Inc., Bentonville, AR 72716
by LUPIN SOMERSET
- Reason
- Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.
- Published
- July 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01
by Qualgen, LLC
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date.
- Published
- July 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01
by Qualgen, LLC
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date.
- Published
- July 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.
by Ingenus Pharmaceuticals Llc
- Reason
- Superpotent Drug: High out of specification assay value results for potency.
- Published
- July 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05.
by Ingenus Pharmaceuticals Llc
- Reason
- Superpotent Drug: High out of specification assay value results for potency.
- Published
- July 11, 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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