Drug Recall
Terminated
Historical recordClass II
Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03
by Aurobindo Pharma USA Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Recall initiated
- January 14, 2022
- Reported by FDA
- February 23, 2022
- Distribution
- USA Nationwide
View recall →
Drug Recall
Ongoing
Historical recordClass II
NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream, 4 oz tubes, Manufactured for NaturesPlus 548 Broadhollow Road, Melville, NY 11747, USA
by Organics Corporation of America DBA Ambix Laboratories
- Reason
- MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.
- Recall initiated
- December 6, 2021
- Reported by FDA
- February 23, 2022
- Distribution
- The product went to one consignee. Natural Organics, Inc., 548 Broadhollow Rd., Melville, NY 11747.
View recall →
Drug Recall
Terminated
Historical recordClass II
Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1768-36.
by Lannett Company, Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results for related substances.
- Recall initiated
- February 9, 2022
- Reported by FDA
- February 23, 2022
- Distribution
- Product was distributed nationwide in the USA.
View recall →
Drug Recall
Terminated
Historical recordClass I
365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
by Je Dois Lavoir LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.
- Recall initiated
- August 2, 2021
- Reported by FDA
- February 23, 2022
- Distribution
- Sold online via website nationwide in the USA and Canada.
View recall →
Drug Recall
Terminated
Historical recordClass I
HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59
by Esupplementsales, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.
- Recall initiated
- January 28, 2022
- Reported by FDA
- February 16, 2022
- Distribution
- Nationwide in the USA via Amazon at www.amazon.com
View recall →
Drug Recall
Terminated
Historical recordClass I
MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, ASIN B08Z74KS88
by Junp Hydration LLC
- Reason
- Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- Recall initiated
- February 4, 2022
- Reported by FDA
- February 16, 2022
- Distribution
- Product was distributed nationwide in the USA via Amazon Marketplace
View recall →
Drug Recall
Terminated
Historical recordClass I
Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-234-10
by AuroMedics Pharma LLC
- Reason
- Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
- Recall initiated
- January 26, 2022
- Reported by FDA
- February 16, 2022
- Distribution
- Nationwide in the US
View recall →
Drug Recall
Terminated
Historical recordClass II
Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00
by ULTRAtab Laboratories, Inc.
- Reason
- CGMP Deviations
- Recall initiated
- January 26, 2022
- Reported by FDA
- February 16, 2022
- Distribution
- Bulk product was distributed to 3 distributors who may have distributed finished product.
View recall →
Drug Recall
Terminated
Historical recordClass II
DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-941-00
by ULTRAtab Laboratories, Inc.
- Reason
- CGMP Deviations
- Recall initiated
- January 26, 2022
- Reported by FDA
- February 16, 2022
- Distribution
- Bulk product was distributed to 3 distributors who may have distributed finished product.
View recall →
Drug Recall
Terminated
Historical recordClass II
Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00
by ULTRAtab Laboratories, Inc.
- Reason
- CGMP Deviations
- Recall initiated
- January 26, 2022
- Reported by FDA
- February 16, 2022
- Distribution
- Bulk product was distributed to 3 distributors who may have distributed finished product.
View recall →
Drug Recall
Terminated
Historical recordClass II
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00
by ULTRAtab Laboratories, Inc.
- Reason
- CGMP Deviations
- Recall initiated
- January 26, 2022
- Reported by FDA
- February 16, 2022
- Distribution
- Bulk product was distributed to 3 distributors who may have distributed finished product.
View recall →
Drug Recall
Terminated
Historical recordClass II
Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-740-00
by ULTRAtab Laboratories, Inc.
- Reason
- CGMP Deviations
- Recall initiated
- January 26, 2022
- Reported by FDA
- February 16, 2022
- Distribution
- Bulk product was distributed to 3 distributors who may have distributed finished product.
View recall →
Drug Recall
Terminated
Historical recordClass II
Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-710-00
by ULTRAtab Laboratories, Inc.
- Reason
- CGMP Deviations
- Recall initiated
- January 26, 2022
- Reported by FDA
- February 16, 2022
- Distribution
- Bulk product was distributed to 3 distributors who may have distributed finished product.
View recall →
Drug Recall
Terminated
Historical recordClass II
Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-00
by ULTRAtab Laboratories, Inc.
- Reason
- CGMP Deviations
- Recall initiated
- January 26, 2022
- Reported by FDA
- February 16, 2022
- Distribution
- Bulk product was distributed to 3 distributors who may have distributed finished product.
View recall →
Drug Recall
Terminated
Historical recordClass II
APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00
by ULTRAtab Laboratories, Inc.
- Reason
- CGMP Deviations
- Recall initiated
- January 26, 2022
- Reported by FDA
- February 16, 2022
- Distribution
- Bulk product was distributed to 3 distributors who may have distributed finished product.
View recall →
Drug Recall
Terminated
Historical recordClass II
Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00
by ULTRAtab Laboratories, Inc.
- Reason
- CGMP Deviations
- Recall initiated
- January 26, 2022
- Reported by FDA
- February 16, 2022
- Distribution
- Bulk product was distributed to 3 distributors who may have distributed finished product.
View recall →
Drug Recall
Terminated
Historical recordClass II
Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00
by ULTRAtab Laboratories, Inc.
- Reason
- CGMP Deviations
- Recall initiated
- January 26, 2022
- Reported by FDA
- February 16, 2022
- Distribution
- Bulk product was distributed to 3 distributors who may have distributed finished product.
View recall →
Drug Recall
Terminated
Historical recordClass II
Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-333-00
by ULTRAtab Laboratories, Inc.
- Reason
- CGMP Deviations
- Recall initiated
- January 26, 2022
- Reported by FDA
- February 16, 2022
- Distribution
- Bulk product was distributed to 3 distributors who may have distributed finished product.
View recall →
Drug Recall
Terminated
Historical recordClass II
Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00
by ULTRAtab Laboratories, Inc.
- Reason
- CGMP Deviations
- Recall initiated
- January 26, 2022
- Reported by FDA
- February 16, 2022
- Distribution
- Bulk product was distributed to 3 distributors who may have distributed finished product.
View recall →
Drug Recall
Terminated
Historical recordClass II
Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00
by ULTRAtab Laboratories, Inc.
- Reason
- CGMP Deviations
- Recall initiated
- January 26, 2022
- Reported by FDA
- February 16, 2022
- Distribution
- Bulk product was distributed to 3 distributors who may have distributed finished product.
View recall →
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.
