Chapter 01 — Drugs recalls

Drugs recalls, as they break.

FDA drug enforcement recalls — contamination, potency, packaging defects.

Updated 2026-08-06 · 300 recalls tracked

Chapter 02 — Drugs recalls

The current drugs recall list.

38 recalls in Drugs

Drugs FDA

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 Vietn

Brand: Rohto-Mentholatum (Vietnam) Co., Ltd.

Hazard: Lack of Assurance of Sterility

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Rohto-Mentholatum (Vietnam) Co., Ltd..

Official notice ↗ Find a safe replacement
Drugs FDA

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. Distri

Brand: Major Pharmaceuticals

Hazard: Subpotent Drug

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Major Pharmaceuticals.

Official notice ↗ Find a safe replacement
Drugs FDA

Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in V

Brand: Rohto-Mentholatum (Vietnam) Co., Ltd.

Hazard: Lack of Assurance of Sterility

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Rohto-Mentholatum (Vietnam) Co., Ltd..

Official notice ↗ Find a safe replacement
Drugs FDA

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. Dist

Brand: Major Pharmaceuticals

Hazard: Subpotent Drug

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Major Pharmaceuticals.

Official notice ↗ Find a safe replacement
Drugs FDA

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

Brand: Major Pharmaceuticals

Hazard: Subpotent Drug

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Major Pharmaceuticals.

Official notice ↗ Find a safe replacement
Drugs FDA

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; N

Brand: Fresenius Kabi Usa, Llc

Hazard: Presence of Particulate Matter: Hair was found in products

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Fresenius Kabi Usa, Llc.

Official notice ↗ Find a safe replacement
Drugs FDA

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

Brand: Major Pharmaceuticals

Hazard: Subpotent Drug

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Major Pharmaceuticals.

Official notice ↗ Find a safe replacement
Drugs FDA

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. Dist

Brand: Major Pharmaceuticals

Hazard: Subpotent Drug

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Major Pharmaceuticals.

Official notice ↗ Find a safe replacement
Drugs FDA

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

Brand: Major Pharmaceuticals

Hazard: Subpotent Drug

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Major Pharmaceuticals.

Official notice ↗ Find a safe replacement
Drugs FDA

Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310

Brand: Rohto-Mentholatum (Vietnam) Co., Ltd.

Hazard: Lack of Assurance of Sterility

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Rohto-Mentholatum (Vietnam) Co., Ltd..

Official notice ↗ Find a safe replacement
Drugs FDA

Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial:

Brand: Fresenius Kabi Usa, Llc

Hazard: Presence of Particulate Matter: Hair was found in products

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Fresenius Kabi Usa, Llc.

Official notice ↗ Find a safe replacement
Drugs FDA

Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135

Brand: Rohto-Mentholatum (Vietnam) Co., Ltd.

Hazard: Lack of Assurance of Sterility

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Rohto-Mentholatum (Vietnam) Co., Ltd..

Official notice ↗ Find a safe replacement
Drugs FDA

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

Brand: Major Pharmaceuticals

Hazard: Subpotent Drug

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Major Pharmaceuticals.

Official notice ↗ Find a safe replacement
Drugs FDA

Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323

Brand: Fresenius Kabi Usa, Llc

Hazard: Presence of Particulate Matter: Hair was found in products

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Fresenius Kabi Usa, Llc.

Official notice ↗ Find a safe replacement
Drugs FDA

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.

Brand: Asclemed Usa Inc.

Hazard: Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

What to do: Class III recall (Ongoing). Stop using / discard the affected lot; contact Asclemed Usa Inc..

Official notice ↗ Find a safe replacement
Drugs FDA

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 07

Brand: Ascend Laboratories, Llc

Hazard: Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Ascend Laboratories, Llc.

Official notice ↗ Find a safe replacement
Drugs FDA

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. Distri

Brand: Major Pharmaceuticals

Hazard: Subpotent Drug

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Major Pharmaceuticals.

Official notice ↗ Find a safe replacement
Drugs FDA

Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).

Brand: Precision Dose Inc.

Hazard: Due to an out-of-specification result for an unidentified impurity detected during routine stability testing.

What to do: Not Yet Classified recall (Ongoing). Stop using / discard the affected lot; contact Precision Dose Inc..

Official notice ↗ Find a safe replacement
Drugs FDA

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. N

Brand: Major Pharmaceuticals

Hazard: Subpotent Drug

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Major Pharmaceuticals.

Official notice ↗ Find a safe replacement
Drugs FDA

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,

Brand: Rohto-Mentholatum (Vietnam) Co., Ltd.

Hazard: Lack of Assurance of Sterility

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Rohto-Mentholatum (Vietnam) Co., Ltd..

Official notice ↗ Find a safe replacement
Drugs FDA

Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial:

Brand: Fresenius Kabi Usa, Llc

Hazard: Presence of Particulate Matter: Hair was found in products

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Fresenius Kabi Usa, Llc.

Official notice ↗ Find a safe replacement
Drugs FDA

Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 6

Brand: Fresenius Kabi Usa, Llc

Hazard: Presence of Particulate Matter: Hair was found in product

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Fresenius Kabi Usa, Llc.

Official notice ↗ Find a safe replacement
Drugs FDA

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. N

Brand: Major Pharmaceuticals

Hazard: Subpotent Drug

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Major Pharmaceuticals.

Official notice ↗ Find a safe replacement
Drugs FDA

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. Distri

Brand: Major Pharmaceuticals

Hazard: Subpotent Drug

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Major Pharmaceuticals.

Official notice ↗ Find a safe replacement
Drugs FDA

Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton

Brand: Rising Pharma Holding, Inc.

Hazard: Presence of Precipitate: medication was crystallizing and particles floating in the bottle

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Rising Pharma Holding, Inc..

Official notice ↗ Find a safe replacement
Drugs FDA

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

Brand: Rohto-Mentholatum (Vietnam) Co., Ltd.

Hazard: Lack of Assurance of Sterility

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Rohto-Mentholatum (Vietnam) Co., Ltd..

Official notice ↗ Find a safe replacement
Drugs FDA

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. N

Brand: Major Pharmaceuticals

Hazard: Subpotent Drug

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Major Pharmaceuticals.

Official notice ↗ Find a safe replacement
Drugs FDA

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-

Brand: Chiesi Usa, Inc.

Hazard: Lack of Assurance of Sterility

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Chiesi Usa, Inc..

Official notice ↗ Find a safe replacement
Drugs FDA

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

Brand: Bell Pharmaceuticals, Inc

Hazard: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Bell Pharmaceuticals, Inc.

Official notice ↗ Find a safe replacement
Drugs FDA

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 Produc

Brand: Bell Pharmaceuticals, Inc

Hazard: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Bell Pharmaceuticals, Inc.

Official notice ↗ Find a safe replacement
Drugs FDA

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.

Brand: Bell Pharmaceuticals, Inc

Hazard: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Bell Pharmaceuticals, Inc.

Official notice ↗ Find a safe replacement
Drugs FDA

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.

Brand: Bell Pharmaceuticals, Inc

Hazard: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Bell Pharmaceuticals, Inc.

Official notice ↗ Find a safe replacement
Drugs FDA

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, subs

Brand: Carefusion 213, Llc

Hazard: Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Carefusion 213, Llc.

Official notice ↗ Find a safe replacement
Drugs FDA

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.

Brand: Bell Pharmaceuticals, Inc

Hazard: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Bell Pharmaceuticals, Inc.

Official notice ↗ Find a safe replacement
Drugs FDA

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

Brand: Padagis Us Llc

Hazard: Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Padagis Us Llc.

Official notice ↗ Find a safe replacement
Drugs FDA

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.

Brand: Bell Pharmaceuticals, Inc

Hazard: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Bell Pharmaceuticals, Inc.

Official notice ↗ Find a safe replacement
Drugs FDA

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, Woonsock

Brand: Bell Pharmaceuticals, Inc

Hazard: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Bell Pharmaceuticals, Inc.

Official notice ↗ Find a safe replacement
Drugs FDA

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 VILL

Brand: Bell Pharmaceuticals, Inc

Hazard: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Bell Pharmaceuticals, Inc.

Official notice ↗ Find a safe replacement

Chapter 03 — Personalised alerts

We watch the feeds. You get the email.

Pick your categories. We email you a digest whenever a new matching recall drops. Free, unsubscribe anytime.

Chapter 04 — For developers & compliance teams

A recall API: one JSON feed across CPSC, FDA, NHTSA & USDA.

The government recall APIs are fragmented — different formats, IDs, date conventions, and NHTSA has no bulk feed at all. Recall Alert exposes the unified cross-agency schema they don't offer: one GET /api/recalls endpoint returning normalized JSON (agency, category, brand, hazard, date, remedy). Built for product-liability law, insuretech underwriting and compliance monitoring.

Keywords we serve: recall API JSON · CPSC FDA NHTSA combined feed · product recall API · unified recall data feed.

Chapter 05 — Good to know

Frequently asked questions.

Where does this recall data come from?

Live government feeds: the FDA openFDA enforcement API (food, drugs, medical devices), the NHTSA vehicle recalls API, and the CPSC SaferProducts API for consumer and children’s products. We normalize them into one list and refresh every 6 hours.

Is this the official recall source?

No. We aggregate and link to the official agency notice for each recall. Always confirm details and remedies on the linked FDA, NHTSA, or CPSC page before acting.

How do I get alerts for my products?

Enter your email and pick the categories you care about. When a new matching recall appears, you get an email digest. Unsubscribe anytime.

How often is the list updated?

Every 6 hours via an automated job. The "Updated" timestamp at the top of the page shows the last successful refresh.

Is it free?

Yes. The recall feed and email alerts are free. We may earn a commission on replacement-product links, which helps keep it running.