FDA Recall
Terminated
Historical recordClass III
Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Distributed By: McKesson Corporation 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India NDC 63739-795-10
by McKesson Corporation dba McKesson Drug Company
- Reason
- Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is labeled correctly as Levetiracetam
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use Only, Manufactured by Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-244-01
by Medline Industries Inc
- Reason
- Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451
by Fresenius Medical Care Holdings, Inc.
- Reason
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-212-92
by Fresenius Medical Care Holdings, Inc.
- Reason
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451,
by Fresenius Medical Care Holdings, Inc.
- Reason
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-206-92
by Fresenius Medical Care Holdings, Inc.
- Reason
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50
by Fresenius Medical Care Holdings, Inc.
- Reason
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451
by Fresenius Medical Care Holdings, Inc.
- Reason
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50
by Fresenius Medical Care Holdings, Inc.
- Reason
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
by Fresenius Medical Care Holdings, Inc.
- Reason
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Arizona Nutritional Supplements
- Product
- 365 Everyday Value Whey Protein Powder Natural Vanilla Flavo…
- Reason
- Whey Protein Powder was mistakenly packaged with Soy Protein Powder.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.
by PFIZER, INC
- Reason
- Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
- Published
- June 9, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.
by PFIZER, INC
- Reason
- Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
- Published
- June 9, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10
by Oxford Pharmaceuticals, LLC
- Reason
- Presence of Foreign Tablets/Capsules
- Published
- June 9, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA; Manufactured by: Mylan Institutional, Galway, Ireland. NDC: 67457-196-02
by Mylan Institutional LLC
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.
- Published
- June 9, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx only, NDC 0597-0041-37), Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- Subpotent Drug
- Published
- June 9, 2021
- Distribution
- AR, CO, CT, LA, NC, ND, NH, NJ, OH, PA a…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Hi Tech Pharmaceuticals
- Product
- Lipodrene With 25mg Ephedra Extract 100CT UPC 8 57084 00056…
- Reason
- The firm was notified by the FDA that the product contains the unapproved food additive 1,4-dimethylamylamine (DMAA).
- Published
- June 9, 2021
- Distribution
- The product was shipped to the following…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Clio LLC
- Product
- Clio Yogurt Bar Mixed Berry Low Sugar Bar 50g x 10 Clio Reta…
- Reason
- Possible metal fragments in Yogurt Bars
- Published
- June 9, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Clio LLC
- Product
- Clio Yogurt Bar Raspberry / Peach Mini Club pack Clio 24g x…
- Reason
- Possible metal fragments in Yogurt Bars
- Published
- June 9, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Clio LLC
- Product
- Clio Greek Yogurt Bar Strawberry Minis 6.2oz pouch x 6 pouch…
- Reason
- Possible metal fragments in Yogurt Bars
- Published
- June 9, 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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