Drug recalls, 2026-W30

FDA drug recalls, July 20 to 26, 2026

FDA posted 14 drug recalls the week of July 20, 2026: 14 Class II. Bell Pharmaceuticals, Inc has the most, with 11.

License: openFDA publishes this file under CC0 1.0.

FDA sorts recalls by risk. Class I: using the product could cause serious health problems or death. Class II: it could cause temporary or reversible health problems. Class III: it is unlikely to cause health problems.

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Recalls posted July 20 to 26, 2026

Class II · Posted July 22, 2026 · Started July 9, 2026 · Ongoing

chlorhexidine gluconate and isopropyl alcohol

Product
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31
Firm
CareFusion 213, LLC, El Paso, TX
Reason
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
Lots
Lots: 4062535, 4065201, 4066446, Exp. 2/28/2027; 4141090, Exp. 5/31/2027; 4180288, 4197695, 4197697, 4180291, Exp. 6/30/2027; 4219454, 4221945, 4221966, 4222853, 4224361, Exp. 7/31/2027; 4228482, 4248656, 4249026, 4248961, 4249818, 4250729, Exp. 8/31/2027; 5124984, 5127231, 5129058, 5126398, 5129488, Exp. 4/30/2028; 5130576, 5142947, 5147432, 5154673, 5154671, 5156442, 5157968, 5158031, 5150160, 5155824, Exp. 5/31/2028; 5176326, 5181676, 5181074, 5182660, 5188102, 5188103, Exp. 6/30/2028; 5195818, 5199118, 5209474, 5210853, 5211985, 5211907, 5211212, Exp. 7/31/2028; 5226576, 5227151…
Quantity
43,066,599 units
Distribution
U.S.A. Nationwide
RxNorm
chlorhexidine gluconate and isopropyl alcohol (RxCUI 858726, 998282)
Recall number
D-0690-2026

Class II · Posted July 22, 2026 · Started July 6, 2026 · Ongoing

clevipidine

Product
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.
Firm
Chiesi USA, Inc., Cary, NC
Reason
Lack of Assurance of Sterility
Lots
Lot #: 1239521, 1237454, Exp. Date 10/2027
Quantity
44280 vials
Distribution
Nationwide within the United States
RxNorm
clevipidine (RxCUI 1790239, 1790242, 1790245, 1790246)
Recall number
D-0689-2026

Class II · Posted July 22, 2026 · Started June 25, 2026 · Ongoing

CAREone

Product
CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.
Firm
Bell Pharmaceuticals, Inc, Belle Plaine, MN
Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots
Lot:1505141, exp 2027-04.
Quantity
1,201 units
Distribution
U.S Nationwide
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0688-2026

Class II · Posted July 22, 2026 · Started June 25, 2026 · Ongoing

carbamide peroxide

Product
meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.
Firm
Bell Pharmaceuticals, Inc, Belle Plaine, MN
Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots
Lot:1505344, exp 2027-04.
Quantity
993 units
Distribution
U.S Nationwide
RxNorm
carbamide peroxide (RxCUI 702050)
Recall number
D-0687-2026

Class II · Posted July 22, 2026 · Started June 25, 2026 · Ongoing

Foster & Thrive

Product
Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.
Firm
Bell Pharmaceuticals, Inc, Belle Plaine, MN
Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots
Lot:1505161, 1505181, 1505301, 1505382, exp 2027-04.
Quantity
31,094 units
Distribution
U.S Nationwide
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0686-2026

Class II · Posted July 22, 2026 · Started June 25, 2026 · Ongoing

carbamide peroxide

Product
LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.
Firm
Bell Pharmaceuticals, Inc, Belle Plaine, MN
Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots
Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.
Quantity
5, 471 units
Distribution
U.S Nationwide
RxNorm
carbamide peroxide (RxCUI 702050)
Recall number
D-0685-2026

Class II · Posted July 22, 2026 · Started June 25, 2026 · Ongoing

carbamide peroxide

Product
GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428.
Firm
Bell Pharmaceuticals, Inc, Belle Plaine, MN
Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots
Lot: a) 1505334, expires: 2027-04; b) 1505143, 1505151, expires: 2027-04
Quantity
20, 160 units
Distribution
U.S Nationwide
RxNorm
carbamide peroxide (RxCUI 702050)
Recall number
D-0684-2026

Class II · Posted July 22, 2026 · Started June 25, 2026 · Ongoing

carbamide peroxide

Product
FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320.
Firm
Bell Pharmaceuticals, Inc, Belle Plaine, MN
Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots
Lot: 1505124, 1505311, 1505332, expires: 2027-04.
Quantity
11, 977 units
Distribution
U.S Nationwide
RxNorm
carbamide peroxide (RxCUI 702050)
Recall number
D-0683-2026

Class II · Posted July 22, 2026 · Started June 25, 2026 · Ongoing

carbamide peroxide

Product
AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.
Firm
Bell Pharmaceuticals, Inc, Belle Plaine, MN
Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots
Lot: a)1505123, expires: 2027-04; b) 1505131, expires: 2027-04.
Quantity
5,762 units
Distribution
U.S Nationwide
RxNorm
carbamide peroxide (RxCUI 702050)
Recall number
D-0682-2026

Class II · Posted July 22, 2026 · Started June 25, 2026 · Ongoing

carbamide peroxide

Product
TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.
Firm
Bell Pharmaceuticals, Inc, Belle Plaine, MN
Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots
Lot: a) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04.
Quantity
16,156 units
Distribution
U.S Nationwide
RxNorm
carbamide peroxide (RxCUI 702050)
Recall number
D-0681-2026

Class II · Posted July 22, 2026 · Started June 25, 2026 · Ongoing

carbamide peroxide

Product
QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376.
Firm
Bell Pharmaceuticals, Inc, Belle Plaine, MN
Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots
Lot: a) 1505121, 1505342, exp 2027-04; b) 1505381, exp 2027-04.
Quantity
15, 843 units
Distribution
U.S Nationwide
RxNorm
carbamide peroxide (RxCUI 702050)
Recall number
D-0680-2026

Class II · Posted July 22, 2026 · Started June 25, 2026 · Ongoing

carbamide peroxide

Product
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.
Firm
Bell Pharmaceuticals, Inc, Belle Plaine, MN
Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots
Lot: a) 1504241, exp 2027-03; b) 1504291, 1504301, exp 2027-03.
Quantity
29, 474 units
Distribution
U.S Nationwide
RxNorm
carbamide peroxide (RxCUI 702050)
Recall number
D-0679-2026

Class II · Posted July 22, 2026 · Started June 25, 2026 · Ongoing

carbamide peroxide

Product
CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,
Firm
Bell Pharmaceuticals, Inc, Belle Plaine, MN
Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots
Lot: a) 1505121, 1504242, exp 2027-03; 1505132, 1505182, 1505191, 1505291, 1505331, exp 2027-04; b) 1504231, 1504311, exp 2027-03; 1505312, 1505321, exp 2027-04.
Quantity
106,301 units
Distribution
U.S Nationwide
RxNorm
carbamide peroxide (RxCUI 702050)
Recall number
D-0678-2026

Class II · Posted July 22, 2026 · Started June 23, 2026 · Ongoing

nystatin

Product
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35
Firm
Padagis US LLC, Minneapolis, MN
Reason
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Lots
Lot #: 205060, Exp 09/30/2027
Quantity
180,936 tubes
Distribution
USA Nationwide
RxNorm
nystatin (RxCUI 543546)
Recall number
D-0677-2026

Source: openFDA drug enforcement reports, as of October 14, 2026. Publisher page

About this data

Each row is one FDA drug enforcement report: one product from one firm. A week here is Monday to Sunday, keyed on the date FDA listed the recall in its weekly Enforcement Report. The date the firm started the recall is shown on each row and is often weeks earlier.

Class I means use of the product could cause serious health problems or death. Class II means it could cause temporary or reversible health problems. Class III means it is unlikely to cause health problems. RxNorm names and RxCUIs come from openFDA's match of the product to its drug label. Compounded products often have no match.

This page lists public records. It is not medical advice. Check the FDA record before acting on a recall.

Source: openFDA drug enforcement reports, as of October 14, 2026. Publisher page

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