FDA Recall
Terminated
Historical recordClass II
Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80
by Eli Lilly & Company
- Reason
- Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21.
by KVK-Tech, Inc.
- Reason
- Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01
by Hikma Pharmaceuticals USA Inc.
- Reason
- Labeling: Not elsewhere classified: Mislabeling
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030
by HIS ENTERPRISE INC
- Reason
- Marketed without ANDA/NDA approval
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59
by Teligent Pharma, Inc.
- Reason
- Defective container: possibility for lack of seal integrity.
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01
by SterRx, LLC
- Reason
- Non-Sterility: firm's third party lab confirmed microbial contamination.
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
by SigmaPharm Laboratories LLC
- Reason
- Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01
by Custopharm, Inc.
- Reason
- Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)00318019000161
by Professional Disposables International, Inc
- Reason
- SubPotent: Out of Specification
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.
by Professional Disposables International, Inc
- Reason
- SubPotent: Out of Specification
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.
by Professional Disposables International, Inc
- Reason
- SubPotent: Out of Specification
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S41125 NDC 10819-3885-2, UPC (01)00310819000185
by Professional Disposables International, Inc
- Reason
- SubPotent: Out of Specification
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376 Reorder No S41350 NDC 10819-3885-1, UPC (01)00310819000178.
by Professional Disposables International, Inc
- Reason
- SubPotent: Out of Specification
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 USA Reorder No C12400 NDC 10819-3883-3, UPC (01)00310819000154
by Professional Disposables International, Inc
- Reason
- SubPotent: Out of Specification
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc., Orangeburg, NY 10962-1376 Reorder No. B40600; UPC (01)00310819000147, NDC 10819-3883-1,
by Professional Disposables International, Inc
- Reason
- SubPotent: Out of Specification
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01
by XELLIA PHARMACEUTICALS USA, LLC
- Reason
- Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-036-01
by XELLIA PHARMACEUTICALS USA, LLC
- Reason
- Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
CAHILLS FARM CHEESE LIMITED
- Product
- Lidl Preferred Selection-Red Wine Cheddar - 7 oz.
- Reason
- Cheese may be contaminated with Listeria monocytogenes.
- Published
- September 1, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
CAHILLS FARM CHEESE LIMITED
- Product
- Lidl Preferred Selection-Irish Stout Cheddar - 7 oz.
- Reason
- Cheese may be contaminated with Listeria monocytogenes.
- Published
- September 1, 2021
- 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.
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