Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
1,070 recalls
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Class II Ongoing
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UP…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1
- Lots / codes
- Lot #: 3H1V, 3H1VA, Exp. Date 2025/07; 3J1V, 3J2V, Exp. Date 2025/09; 3K1V, Exp. Date 2025/10; 4F1V, Exp. Date 2027/05; 4F1VA, Exp. Date 2027/05; 4H1V, Exp. Date 2027/07; 4I1V, Exp. Date 2027/08; 4K1V, 4K2V,Exp. Date 2027/10; 5A1V, 5A2V, Exp. Date 2027/12; 5D1V, Exp. Date 2028/03; 5E1V, Exp. Date2028/04; 5J1V, 5J2V, Exp. Date 2028/09; 6B1V, Exp. Date 2029/01; 6C1V, 6C1VA, 6C1VB, Exp. Date 2029/02.
- Distribution
- Nationwide within the United States
- Quantity
- 1,278,457 cartons
- Recall started
- July 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0718-2026
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Class II Ongoing
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 31…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2
- Lots / codes
- Lot #: 3H1V, Exp. Date2026/07; 3J2V, Exp. Date 2026/09; 4A1V, 4A1VA, Exp. Date 2026/12; 4G1V, Exp. Date 2027/06; 4I3V, Exp. Date 2027/08; 5A1V, Exp. Date 2027/12; 5B3V, Exp. Date2028/01; 5G3V, Exp. Date 2028/06; 5J1V, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6A1V, Exp. Date 2028/12; 6B4V, Exp. Date 2029/01; 6C2V, Exp. Date 2029/02.
- Distribution
- Nationwide within the United States
- Quantity
- 499,673 cartons
- Recall started
- July 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0717-2026
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Class II Ongoing
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012,…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1
- Lots / codes
- Lot #: 3H2V, 3H3V, Exp. Date 2026/07; 3J1V, 3J3V, 3J4V, 3J5V, Exp. Date 2026/09; 3K1V, 3K2V, Exp. Date 2026/10; 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, 4B3V, Exp. Date 2027/01; 4F1V, 4F2V, 4F2V, 4F3V, 4F4V, Exp. Date 2027/05; 4G2V, 4G3V, 4G4V, 4G5V, Exp. Date 2027/06; 4H1V, Exp. Date 2027/07; 4I1V, 4I2V, 4I4V, 4I5V, Exp. Date 2027/08.
- Distribution
- Nationwide within the United States
- Quantity
- 6076306 cartons
- Recall started
- July 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0716-2026
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Class II Ongoing
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 3107…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1
- Lots / codes
- Lot #: 3H1V, Exp. Date 2026/07; 3J1V, 3J2V, Exp. Date 2026/09; 3K1V, Exp. Date 2026/10; 4A1V, 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, Exp. Date 2027/01; 4G1V, 4G2V, 4G3V, Exp. Date 2027/06; 4I1V, 4I2V, 4I2VA Exp. Date 2027/08; 4J1V, 4J2V, Exp. Date 2027/09; 4K2V, 4K3V, 4K4V Exp. Date2027/10; 5B1V, 5B2V, 5B3V, Exp. Date 2028/01; 5D1V, Exp. Date 2028/03; 5E1V, 5E2V, 5E3V, Exp. Date 2028/04; 5H1V, Exp. Date 2028/07; 5I1V, Exp. Date 2028/08; 5J1V, 5J2V, Exp. Date 2028/09; 5L1V, 5L1VA, 5L1VB, 5L1VC, 5L1VD, 5L2V,Exp. Date 2028/11; 6A1V, 6A2V, Exp. Date 2028/12; 6B1V, Exp. Date 2029/01 & Lot 6C1V, Exp. Date 2029/02.
- Distribution
- Nationwide within the United States
- Quantity
- 1.033,266 cartons
- Recall started
- July 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0715-2026
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Class III Ongoing
Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-760-01.
Reason: Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Lots, distribution and details
- Lots / codes
- Lot: 070126X1, Exp. 12/31/2027.
- Distribution
- Within U.S. – Tennessee
- Quantity
- 18 kits
- Recall started
- July 15, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0713-2026
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Class II Ongoing
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-…
Reason: Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Lots, distribution and details
- Product
- Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30
- Lots / codes
- Lot 25121311, expiry 3/31/2028
- Distribution
- Nationwide in the USA
- Quantity
- 6,192 bottles
- Recall started
- July 8, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0712-2026
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Class II Ongoing
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal…
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3563-0; NDC Blister: 0904-6956-61
- Lots / codes
- Bag lot #: N02167A, Exp. Date 07/2026; Blister lot # N02167, Exp. Date 07/2026
- Distribution
- Nationwide in the USA.
- Quantity
- N/A
- Recall started
- July 13, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0711-2026
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Class II Ongoing
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal…
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3562-0; NDC Blister: 0904-6951-61
- Lots / codes
- Bag lot #: N02266A, N02266B, Exp. Date 11/2026; Blister lot #: N02266, Exp. Date 11/2026
- Distribution
- Nationwide in the USA.
- Quantity
- N/A
- Recall started
- July 13, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0710-2026
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Class II Ongoing
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal He…
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3560-0; NDC Blister: 0904-6951-61
- Lots / codes
- Bag lot #: N02172A, N02172B, Exp. Date 07/2026; N02288A, N02288B, Exp. Date 12/2026; Blister lot #: N02172, Exp. Date 07/2026; N02288, Exp. Date 12/2026
- Distribution
- Nationwide in the USA.
- Quantity
- N/A
- Recall started
- July 13, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0709-2026
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Class II Ongoing
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal He…
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3559-0; NDC Blister: 0904-6950-61
- Lots / codes
- Bag lot #: N02200A, N02200B, Exp. Date 10/2026; Blister lot #: N02200, Exp. Date 10/2026
- Distribution
- Nationwide in the USA.
- Quantity
- N/A
- Recall started
- July 13, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0708-2026
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Class II Ongoing
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal He…
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Carton: 55154-3558-0; NDC Blister: 0904-6949-61
- Lots / codes
- Bag lot #: N02212A, N02212B, Exp. Date 07/2026; Blister lot #: N02212, Exp. Date 07/2026
- Distribution
- Nationwide in the USA.
- Quantity
- N/A
- Recall started
- July 13, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0707-2026
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Class II Ongoing
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6956-61
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6956-61
- Lots / codes
- Lot #: N02167, Exp. Date 07/2026
- Distribution
- Nationwide in the USA.
- Quantity
- N/A
- Recall started
- July 13, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0706-2026
-
Class II Ongoing
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6955-61
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6955-61
- Lots / codes
- Lot #: N02266, Exp. Date 11/2026
- Distribution
- Nationwide in the USA.
- Quantity
- N/A
- Recall started
- July 13, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0705-2026
-
Class II Ongoing
Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6954-61
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6954-61
- Lots / codes
- Lot #: N02203, Exp. Date 09/2026
- Distribution
- Nationwide in the USA.
- Quantity
- N/A
- Recall started
- July 13, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0704-2026
-
Class II Ongoing
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6952-61
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6952-61
- Lots / codes
- Lot #: N02310, Exp. Date 01/2027
- Distribution
- Nationwide in the USA.
- Quantity
- N/A
- Recall started
- July 13, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0703-2026
-
Class II Ongoing
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61
- Lots / codes
- Lot# N02172, exp 07/2026; N02296, N02288, Exp. Date 12/2026
- Distribution
- Nationwide in the USA.
- Quantity
- N/A
- Recall started
- July 13, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0702-2026
-
Class II Ongoing
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6950-61
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6950-61
- Lots / codes
- Lot #: N02200, Exp. Date 10/2026
- Distribution
- Nationwide in the USA.
- Quantity
- N/A
- Recall started
- July 13, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0701-2026
-
Class II Ongoing
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61
- Lots / codes
- Lot#: N02212, Exp. Date 07/2026
- Distribution
- Nationwide in the USA.
- Quantity
- N/A
- Recall started
- July 13, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0700-2026
-
Class II Ongoing
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.
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots, distribution and details
- Lots / codes
- Lot:1505141, exp 2027-04.
- Distribution
- U.S Nationwide
- Quantity
- 1,201 units
- Recall started
- June 25, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0688-2026
-
Class II Ongoing
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.
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots, distribution and details
- Lots / codes
- Lot:1505344, exp 2027-04.
- Distribution
- U.S Nationwide
- Quantity
- 993 units
- Recall started
- June 25, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0687-2026
-
Class II Ongoing
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.
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots, distribution and details
- Lots / codes
- Lot:1505161, 1505181, 1505301, 1505382, exp 2027-04.
- Distribution
- U.S Nationwide
- Quantity
- 31,094 units
- Recall started
- June 25, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0686-2026
-
Class II Ongoing
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,…
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots, distribution and details
- 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.
- Lots / codes
- Lot: a) 1505334, expires: 2027-04; b) 1505143, 1505151, expires: 2027-04
- Distribution
- U.S Nationwide
- Quantity
- 20, 160 units
- Recall started
- June 25, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0684-2026
-
Class II Ongoing
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.
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots, distribution and details
- Lots / codes
- Lot: 1505124, 1505311, 1505332, expires: 2027-04.
- Distribution
- U.S Nationwide
- Quantity
- 11, 977 units
- Recall started
- June 25, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0683-2026
-
Class II Ongoing
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.
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots, distribution and details
- 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.
- Lots / codes
- Lot: a)1505123, expires: 2027-04; b) 1505131, expires: 2027-04.
- Distribution
- U.S Nationwide
- Quantity
- 5,762 units
- Recall started
- June 25, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0682-2026
-
Class II Ongoing
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.
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lots, distribution and details
- Lots / codes
- Lot: a) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04.
- Distribution
- U.S Nationwide
- Quantity
- 16,156 units
- Recall started
- June 25, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0681-2026
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.