FDA Recall
Ongoing
2026 recordClass II
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
by Fresenius Medical Care Holdings, Inc.
- Reason
- Lack of Assurance of Sterility: Potential leaks from perforations in bags.
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
by Fresenius Medical Care Holdings, Inc.
- Reason
- Lack of Assurance of Sterility: Potential leaks from perforations in bags.
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass III
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.
by Unichem Pharmaceuticals USA Inc.
- Reason
- Subpotent drug
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
2026 recordClass II
Wehah Farms
- Product
- LUNDBERG FAMILY FAMRS WHITE RICE JASMINE NET WT 32 OZ (2 lb)…
- Reason
- Potential contamination with foreign materials.
- Published
- May 13, 2026
- Distribution
- U.S. States: CA, CT, FL, IL, NC, NH, NY,…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
2026 recordClass I
French Broad Chocolate Factory
- Product
- french broad CHOCOLATE bette's bake sale (a multi-flavor bon…
- Reason
- Undeclared nut allergen (walnut) due to mislabeling. The product's printed tasting guide incorrectly identifies the Walnut Fudge and Peach Cobbler flavor chocolates (bonbons). Consumers relying on the printed materials could mistakenly consume a nut-containing bonbon.
- Published
- May 13, 2026
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
2026 recordClass II
Green Organic Vegetables
- Product
- Woodstock Organic Shelled Edamame 10 oz. and 48 oz.
- Reason
- Foreign object: metal pieces
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
2026 recordClass II
SUNGAL INC
- Product
- XZL, Jelly Snacks, 12.68 OZ, Bag. 12 Bags per Case.
- Reason
- Product Contains undeclared FD&C Yellow #5 & #6 and Red #40
- Published
- May 13, 2026
- Distribution
- The product was distributed to the follo…
View recall →
FDA Recall
🇺🇸 United States
Terminated
2026 recordClass III
Tops Markets LLC
- Product
- Christopher Ranch Peeled Garlic 6 oz.
- Reason
- The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm
- Published
- May 13, 2026
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
2026 recordClass III
Tops Markets LLC
- Product
- Garland Fresh Peeled Garlic 6 oz. bag
- Reason
- The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm
- Published
- May 13, 2026
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
2026 recordClass II
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.
by Hikma Pharmaceuticals USA INC
- Reason
- This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
- Published
- May 6, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass III
Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950
by Water-Jel Technologies, LLC
- Reason
- Failed PH Specifications
- Published
- May 6, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
by Wells Pharma of Houston LLC
- Reason
- cGMP deviations.
- Published
- May 6, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
by Wells Pharma of Houston LLC
- Reason
- cGMP deviations.
- Published
- May 6, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
by Wells Pharma of Houston LLC
- Reason
- cGMP deviations.
- Published
- May 6, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.
by Wells Pharma of Houston LLC
- Reason
- cGMP deviations.
- Published
- May 6, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
by Wells Pharma of Houston LLC
- Reason
- cGMP deviations.
- Published
- May 6, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.
by Wells Pharma of Houston LLC
- Reason
- cGMP deviations.
- Published
- May 6, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
by Wells Pharma of Houston LLC
- Reason
- cGMP deviations.
- Published
- May 6, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11
by Thea Pharma, Inc.
- Reason
- Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
- Published
- May 6, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11
by Thea Pharma, Inc.
- Reason
- Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
- Published
- May 6, 2026
- 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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