FDA Recall
Ongoing
Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3
by Noven Pharmaceuticals Inc
- Reason
- Defective Delivery System: customer complaints exceeded respective action limits.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
by Direct Rx
- Reason
- CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
- Published
- June 1, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2
by Apotex Corp.
- Reason
- Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
- Published
- May 25, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01
by American Health Packaging
- Reason
- Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
- Published
- May 25, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Stability Specification
- Published
- May 25, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
by Pfizer Inc.
- Reason
- CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
- Published
- May 25, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
by Pfizer Inc.
- Reason
- CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
- Published
- May 25, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
by Pfizer Inc.
- Reason
- CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
- Published
- May 25, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-43
by Fagron, Inc
- Reason
- Subpotent Drug
- Published
- May 18, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-56
by Fagron, Inc
- Reason
- Subpotent Drug
- Published
- May 18, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-07
by Fagron, Inc
- Reason
- Subpotent Drug
- Published
- May 18, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-05
by Fagron, Inc
- Reason
- Subpotent Drug
- Published
- May 18, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-04
by Fagron, Inc
- Reason
- Subpotent Drug
- Published
- May 18, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
- Published
- May 18, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-009-16
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
- Published
- May 18, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-738-86
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
- Published
- May 18, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-count bottle (47335-737-88), c)500-count bottle (47335-737-13), Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
- Published
- May 18, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass I
SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.
by Fagron, Inc
- Reason
- Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
- Published
- May 18, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single dose vial, Rx only, Manufactured by Amgen Inc. Thousand Oaks, CA 91320-1799, NDC 55513-0206-01
by Amgen, Inc.
- Reason
- Defective container: loose crimp defect, potential loss of container integrity.
- Published
- May 18, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07.
by Viatris Inc
- Reason
- Failed Dissolution Specifications: low out of specification results for dissolution.
- Published
- May 18, 2022
- 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.
Read the full medical disclaimer.