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
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
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 →
FDA Recall
Ongoing
2026 recordClass II
Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th Floor, New York, NY 10016, USA, NDC 72972-002-01.
by SCOPE HEALTH
- Reason
- Lack of Assurance of Sterility
- Published
- May 6, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass III
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01
by American Regent, Inc.
- Reason
- Labeling: Missing Label
- Published
- May 6, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.
by Alcon Research LLC
- Reason
- Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
- Published
- May 6, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01
by Alcon Research LLC
- Reason
- Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
- Published
- May 6, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
2026 recordClass II
King Juice Company, Inc.
- Product
- Calypso Tropic Tango Lemonade. 16 FL oz (1PT) (473 ML). UP…
- Reason
- Product contains undeclared Yellow No. 5.
- Published
- May 6, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
2026 recordClass II
The Mochi Ice Cream Company, LLC
- Product
- My Mochi Strawberry flavored Non-Dairy Frozen Dessert; 7.5 o…
- Reason
- Foreign object found inside retail container.
- 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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