Drug and pharmaceutical recalls
17707 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2021-07-21FDA-DrugCIPLAClass IISolifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufactured for Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL, 33323, NDC 69097-261-02.
CGMP Deviations
- 2021-07-21FDA-DrugSanit Technologies, LLC dba DurisanClass IIDurisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, packaged in 80-count canister (UPC 8 52379 00632 5), b) 160-count canister (UPC 8 52379 00631 8), and c) 240-count canister (UPC 8 52379 00633 2); Sanit Technologies, LLC, 7810 25th Court East, Sarasota, Florida 34243.
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
- 2021-07-21FDA-DrugSanit Technologies, LLC dba DurisanClass IIDurisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 00614 1); b) 50 mL Net Content 1.69 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 7); c) 118 mL Net Content 4 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 9); d) 236.58 mL Net Content 8 oz bottle, (UPC 8 52379 00635 6); e) 250 mL Net Contents 8.45 oz (UPC 8 52379 00611 0); f) 300 mL Net Content
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
- 2021-07-21FDA-DrugSanit Technologies, LLC dba DurisanClass IDurisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, 160-count canister; Sanit Technologies, LLC, 7810 25th Court East, Sarasota, Florida 34243, UPC 8 52379 00631 8.
Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.
- 2021-07-21FDA-DrugSanit Technologies, LLC dba DurisanClass IDurisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 00614 1); b) 50 mL Net Content 1.69 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 7); c) 118 mL Net Content 4 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 9); d) 236.58 mL Net Content 8 oz bottle, (UPC 8 52379 00635 6); e) 250 mL Net Contents 8.45 oz (UPC 8 52379 00611 0); f) 300 mL Net Content
Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.
- 2021-07-21FDA-DrugPartner Therapeutics IncClass IIILEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials) per box, Rx only, Mfd by Partner Therapeutics, Inc. Lexington, MA 02421, NDC 71837-5843-5
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
- 2021-07-21FDA-DrugYamtun7Class IPoseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
- 2021-07-21FDA-DrugGrato Holdings, Inc.Class IIIB-Force, Homeopathic, 1 Fl Oz (30 mL) bottle, Distributed by: BioActive Nutritional, Inc., Melbourne, FL 32935, NDC 43857-0576-1
Superpotent
- 2021-07-21FDA-DrugThe Harvard Drug GroupClass IINIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count unit dose carton, NDC 0904-7080-06: Distributed by: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
- 2021-07-14FDA-DrugTeva Pharmaceuticals USAClass ITopotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01, Vial NDC# 0703-4714-71
Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
- 2021-07-14FDA-DrugFresenius Kabi USA LLCClass IIXylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37
Low out of specification results for epinephrine assay.
- 2021-07-14FDA-DrugGenentech IncClass IIXolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Syringe. Product of France, Manufactured by: Genentech, Inc. A Member of the Roche Group, South San Francisco, CA 9480-4990. NDC: 50242-215-01
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
- 2021-07-14FDA-DrugAlvogen, IncClass IIBuprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
- 2021-07-07FDA-DrugDIBAR NUTRICIONAL S DE RL DE CVClass IIADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by: Dibar Labs, LLC,.Sugar Land, TX 77479, Distributed by: Lifetime Health Services, Pharr, TX 78577, Made in Mexico, NDC; 79284-005-00. UPC 8 60004 06470 1
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
- 2021-07-07FDA-DrugDIBAR NUTRICIONAL S DE RL DE CVClass IIProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002-01 and b) 16 FL OZ (473.2 mL), NDC 75408-002-02 bottles, Imported by: Dibar Labs, LLC., Sugar Land, TX 77479; Distributed by: PR Trading LLC, PO Box 19647, San Juan, PR 00910, Made in Mexico.
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
- 2021-07-07FDA-DrugDIBAR NUTRICIONAL S DE RL DE CVClass IIDiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.1 mL) bottle, NDC 73009-001-16, UPC 8 53090 00302 0 and b) 8 FL OZ (236.5 mL) bottle, NDC 73009-0001-08, UPC 8 53090 00301 3; Distributed by: S.E.N.D, LLC., Anthony, NM 88021; Imported by: Dibar Labs, LLC., Sugar Land, TX 77479, Made in Mexico.
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
- 2021-07-07FDA-DrugDIBAR NUTRICIONAL S DE RL DE CVClass IDiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distributed by S.E.N.D. LLC, Anthony, NM 88021, Imported by Dibar Labs, LLC, Sugar Land, TX 77479, Made in Mexico,77479, NDC 73009-0001-08 UPC 8 53090 00301 3.
Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
- 2021-07-07FDA-DrugHOYU(US) LOGISTICS INCClass IIQiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun District, Guanzhou, China Distributed by HoYu (US) Logistics Inc UPC 6 926645 716288
Subpotent
- 2021-07-07FDA-DrugNSNY Distributor IncClass IGinseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
- 2021-07-07FDA-DrugNSNY Distributor IncClass IPremium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 32555 7
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
- 2021-06-30FDA-DrugVIONA PHARMACEUTICALS INCClass IIMetformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- 2021-06-30FDA-DrugBausch Health Companies, Inc.Class IIIPhytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30
Failed Impurities/Degradation Specifications
- 2021-06-30FDA-DrugBausch Health Companies, Inc.Class IIIMephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05.
Failed Impurities/Degradation Specifications
- 2021-06-30FDA-DrugHill Dermaceuticals, Inc.Class IIDermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Manasquan, NJ 08736, NDC 68791-103-20
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
- 2021-06-30FDA-DrugTeligent Pharma, Inc.Class IIDiflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310.
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
- 2021-06-30FDA-DrugMiracle 8989Class ImaXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
- 2021-06-30FDA-DrugMiracle 8989Class IPremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
- 2021-06-30FDA-DrugMiracle 8989Class IPremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
- 2021-06-23FDA-DrugPrisma Health Outsourcing FacilityClass IIIKetamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma Health Outsourcing Facility 1071 Holland Rd. Suite 2 Simpsonville, SC 29681. NDC: 73463-0100-01
Labeling: Incorrect Exp. Date: Incorrect BUD.
- 2021-06-23FDA-DrugWorld Source LlcClass IIQiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzhou Minghui Cosmetics Co., Ltd., Baiyun District, Guanzhou
Subpotent
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