FDA Recall
Terminated
Historical recordClass II
Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P. Deauville LLC New Brunswick, NJ 08901, NDC 42913-020-00, UPC 815195014097
by A.P. Deauville, LLC
- Reason
- cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804, NDC 70092143350
by QuVa Pharma, Inc.
- Reason
- Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Published
- July 1, 2020
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Published
- July 1, 2020
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
Sterile Curcumin 50mg/mL, 10 mL vial
by BIOTA Biosciences LLC
- Reason
- Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
by BIOTA Biosciences LLC
- Reason
- Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial
by BIOTA Biosciences LLC
- Reason
- Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sterile Curcumin, 4mg/mL, 10mL vial
by BIOTA Biosciences LLC
- Reason
- Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial
by BIOTA Biosciences LLC
- Reason
- Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
NOW Health Group Inc.
- Product
- NOW Real Food Raw Macadamia Nuts Unsalted 8 oz retail bag…
- Reason
- The product tested positive for Salmonella enterica.
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single pack and twin pack, Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0095-41
by Glaxosmithkline Consumer Healthcare Holdings
- Reason
- Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
- Published
- June 24, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0574-41
by Glaxosmithkline Consumer Healthcare Holdings
- Reason
- Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
- Published
- June 24, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-41
by Glaxosmithkline Consumer Healthcare Holdings
- Reason
- Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
- Published
- June 24, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-42
by Glaxosmithkline Consumer Healthcare Holdings
- Reason
- Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
- Published
- June 24, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30
by Aurobindo Pharma USA Inc.
- Reason
- Failed Impurities/ Degradation Specifications
- Published
- June 24, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30
by Aurobindo Pharma USA Inc.
- Reason
- Failed Impurities/ Degradation Specifications
- Published
- June 24, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate (5%), Net Wt. 0.15 oz. (4.25g) tube, Eco Lips, Inc., Marion, IA 52302, UPC: 859623000030; 859623000177; 859623000573; Display UPC: 859623000092; 859623000108; 859623000139; 859623000146; 859623000184; 859623000535; 859623001037.
by Eco Lips Inc
- Reason
- Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations.
- Published
- June 24, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9583-01
by Hikma Pharmaceuticals USA Inc.
- Reason
- Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
- Published
- June 24, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9701-01
by Hikma Pharmaceuticals USA Inc.
- Reason
- Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
- Published
- June 24, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 count (NDC 42291-610-18); d) 360 count (NDC 42291-610-36); e) 1000 count (NDC 42291-610-10) bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478
by AVKARE Inc.
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Published
- June 24, 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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