Showing 9,661–9,680 of 17,974 drug recalls
Drug Recall
Terminated
Historical record Class III
Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45 by Rhodes Pharmaceuticals, L.P.
Reason
Failed Dissolution Specification: Low dissolution outside of specifications Recall initiated
April 17, 2018 Reported by FDA
May 9, 2018 Distribution
Nationwide within the USA
View recall →
Drug Recall
Terminated
Historical record Class II
Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-245-52 by AuroMedics Pharma LLC
Reason
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap Recall initiated
March 27, 2018 Reported by FDA
May 9, 2018 Distribution
US Nationwide
View recall →
Drug Recall
Terminated
Historical record Class II
Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-244-47 by AuroMedics Pharma LLC
Reason
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap Recall initiated
March 27, 2018 Reported by FDA
May 9, 2018 Distribution
US Nationwide
View recall →
Drug Recall
Terminated
Historical record Class II
Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-248-47. by AuroMedics Pharma LLC
Reason
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap Recall initiated
March 27, 2018 Reported by FDA
May 9, 2018 Distribution
US Nationwide
View recall →
Drug Recall
Terminated
Historical record Class II
Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-247-47. by AuroMedics Pharma LLC
Reason
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap Recall initiated
March 27, 2018 Reported by FDA
May 9, 2018 Distribution
US Nationwide
View recall →
Drug Recall
Terminated
Historical record Class II
Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-246-47. by AuroMedics Pharma LLC
Reason
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap Recall initiated
March 27, 2018 Reported by FDA
May 9, 2018 Distribution
US Nationwide
View recall →
Drug Recall
Terminated
Historical record Class II
Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for: AuroMedics Pharma, LLC, NDC 55150-243-46. by AuroMedics Pharma LLC
Reason
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap Recall initiated
March 27, 2018 Reported by FDA
May 9, 2018 Distribution
US Nationwide
View recall →
Drug Recall
Terminated
Historical record Class II
Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-242-51 by AuroMedics Pharma LLC
Reason
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap Recall initiated
March 27, 2018 Reported by FDA
May 9, 2018 Distribution
US Nationwide
View recall →
Drug Recall
Terminated
Historical record Class II
PYRIDOXINE Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 by Coastal Meds, LLC.
Reason
Presence of Particulate matter. Recall due to presence of unknown particulate matter. Recall initiated
April 5, 2018 Reported by FDA
May 2, 2018 Distribution
Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical record Class II
METHYLCOBALAMIN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 by Coastal Meds, LLC.
Reason
Presence of Particulate matter. Recall due to presence of unknown particulate matter. Recall initiated
April 5, 2018 Reported by FDA
May 2, 2018 Distribution
Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical record Class II
LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 by Coastal Meds, LLC.
Reason
Presence of Particulate matter. Recall due to presence of unknown particulate matter. Recall initiated
April 5, 2018 Reported by FDA
May 2, 2018 Distribution
Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical record Class II
LIPO-DEN PLUS Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 by Coastal Meds, LLC.
Reason
Presence of Particulate matter. Recall due to presence of unknown particulate matter. Recall initiated
April 5, 2018 Reported by FDA
May 2, 2018 Distribution
Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical record Class II
LIPO-DEN EXTREME Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 by Coastal Meds, LLC.
Reason
Presence of Particulate matter. Recall due to presence of unknown particulate matter. Recall initiated
April 5, 2018 Reported by FDA
May 2, 2018 Distribution
Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical record Class II
LIPO-DEN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 by Coastal Meds, LLC.
Reason
Presence of Particulate matter. Recall due to presence of unknown particulate matter. Recall initiated
April 5, 2018 Reported by FDA
May 2, 2018 Distribution
Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical record Class II
LIPO-B Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 by Coastal Meds, LLC.
Reason
Presence of Particulate matter. Recall due to presence of unknown particulate matter. Recall initiated
April 5, 2018 Reported by FDA
May 2, 2018 Distribution
Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical record Class II
HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 by Coastal Meds, LLC.
Reason
Presence of Particulate matter. Recall due to presence of unknown particulate matter. Recall initiated
April 5, 2018 Reported by FDA
May 2, 2018 Distribution
Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical record Class II
ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 by Coastal Meds, LLC.
Reason
Presence of Particulate matter. Recall due to presence of unknown particulate matter. Recall initiated
April 5, 2018 Reported by FDA
May 2, 2018 Distribution
Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical record Class II
CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 by Coastal Meds, LLC.
Reason
Presence of Particulate matter. Recall due to presence of unknown particulate matter. Recall initiated
April 5, 2018 Reported by FDA
May 2, 2018 Distribution
Nationwide in the USA
View recall →
Drug Recall
Terminated
Historical record Class III
Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-016-10 by Mckesson Packaging Services
Reason
Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Recall initiated
April 23, 2018 Reported by FDA
May 2, 2018 Distribution
Nationwide with the US
View recall →
Drug Recall
Terminated
Historical record Class III
Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ 07960. NDC 63739-284-10 by Mckesson Packaging Services
Reason
Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Recall initiated
April 23, 2018 Reported by FDA
May 2, 2018 Distribution
Nationwide with the US
View recall →
Data last updated: September 23, 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 .
