Showing 6,061–6,080 of 17,964 drug recalls
Drug Recall
Terminated
Historical record Class 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 Recall initiated
May 11, 2020 Reported by FDA
July 1, 2020 Distribution
Nationwide within the United States and New Zealand
View recall →
Drug Recall
Terminated
Historical record Class 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 Recall initiated
May 11, 2020 Reported by FDA
July 1, 2020 Distribution
Nationwide within the United States and New Zealand
View recall →
Drug Recall
Terminated
Historical record Class 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 Recall initiated
May 11, 2020 Reported by FDA
July 1, 2020 Distribution
Nationwide within the United States and New Zealand
View recall →
Drug Recall
Terminated
Historical record Class 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 Recall initiated
May 11, 2020 Reported by FDA
July 1, 2020 Distribution
Nationwide within the United States and New Zealand
View recall →
Drug Recall
Terminated
Historical record Class 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 Recall initiated
May 11, 2020 Reported by FDA
July 1, 2020 Distribution
Nationwide within the United States and New Zealand
View recall →
Drug Recall
Terminated
Historical record Class 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. Recall initiated
May 28, 2020 Reported by FDA
June 24, 2020 Distribution
U.S.A. Nationwide
View recall →
Drug Recall
Terminated
Historical record Class 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. Recall initiated
May 28, 2020 Reported by FDA
June 24, 2020 Distribution
U.S.A. Nationwide
View recall →
Drug Recall
Terminated
Historical record Class 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. Recall initiated
May 28, 2020 Reported by FDA
June 24, 2020 Distribution
U.S.A. Nationwide
View recall →
Drug Recall
Terminated
Historical record Class 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. Recall initiated
May 28, 2020 Reported by FDA
June 24, 2020 Distribution
U.S.A. Nationwide
View recall →
Drug Recall
Terminated
Historical record Class 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 Recall initiated
May 26, 2020 Reported by FDA
June 24, 2020 Distribution
U.S.A. Nationwide
View recall →
Drug Recall
Terminated
Historical record Class 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 Recall initiated
May 26, 2020 Reported by FDA
June 24, 2020 Distribution
U.S.A. Nationwide
View recall →
Drug Recall
Terminated
Historical record Class II
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46 by SCA Pharmaceuticals
Reason
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. Recall initiated
June 16, 2020 Reported by FDA
June 24, 2020 Distribution
Product was distributed to hospitals in PA and CA.
View recall →
Drug Recall
Terminated
Historical record Class 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. Recall initiated
May 15, 2020 Reported by FDA
June 24, 2020 Distribution
Nationwide within the US.
View recall →
Drug Recall
Terminated
Historical record Class 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. Recall initiated
June 11, 2020 Reported by FDA
June 24, 2020 Distribution
Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical record Class 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. Recall initiated
June 11, 2020 Reported by FDA
June 24, 2020 Distribution
Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical record Class II
metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) 120 tablets (NDC: 43063-428-98); e) 180 tablets (NDC: 43063-428-93); f) 500 tablets (NDC: 53746-0178-05), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 by PD-Rx Pharmaceuticals, Inc.
Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Recall initiated
June 5, 2020 Reported by FDA
June 24, 2020 Distribution
United States
View recall →
Drug Recall
Terminated
Historical record Class 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 Recall initiated
June 4, 2020 Reported by FDA
June 24, 2020 Distribution
Nationwide.
View recall →
Drug Recall
Terminated
Historical record Class II
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) 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 Recall initiated
June 4, 2020 Reported by FDA
June 24, 2020 Distribution
Nationwide.
View recall →
Drug Recall
Completed
Historical record Class II
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1 by Apotex Inc.
Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels Recall initiated
May 27, 2020 Reported by FDA
June 24, 2020 Distribution
Nationwide.
View recall →
Drug Recall
Terminated
Historical record Class III
Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-040-04 by Akorn, Inc.
Reason
Discoloration: Out of Specification (OOS) result for APHA Color Test. Recall initiated
June 5, 2020 Reported by FDA
June 17, 2020 Distribution
Distributed Nationwide in the USA
View recall →
Data last updated: September 16, 2026 ET
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer .
