enforcement database
FDA Drug Recalls
565 documented actions on record. FDA recalls of pharmaceutical products, including OTC and prescription drugs.
- Total actions
- 565
- Earliest on record
- January 11, 2023
- Most recent
- September 30, 2026
- Source
- openFDA (recall)
Severity breakdown
- Critical40
- High471
- Medium54
Most recent drug recalls (30 of 565 shown)
- Sterling Pharmaceutical Services LLC — Class II recall: AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Dro…
September 30, 2026·High
- Sterling Pharmaceutical Services LLC — Class II recall: AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Dro…
September 30, 2026·High
- Sterling Pharmaceutical Services LLC — Class II recall: Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 coun…
September 30, 2026·High
- Sterling Pharmaceutical Services LLC — Class II recall: Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%,…
September 30, 2026·High
- Macleods Pharmaceuticals Limited — Class III recall: Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleo…
September 30, 2026·Medium
- Sterling Pharmaceutical Services LLC — Class II recall: Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distr…
September 30, 2026·High
- Sterling Pharmaceutical Services LLC — Class II recall: Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye…
September 30, 2026·High
- Sterling Pharmaceutical Services LLC — Class II recall: Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, D…
September 30, 2026·High
- Sterling Pharmaceutical Services LLC — Class II recall: TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose…
September 30, 2026·High
- Amneal Pharmaceuticals of New York, LLC — Class II recall: Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcuta…
September 30, 2026·High
- Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company — Class II recall: Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%,…
September 30, 2026·High
- Sterling Pharmaceutical Services LLC — Class II recall: Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%,…
September 30, 2026·High
- Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company — Class II recall: Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%,…
September 30, 2026·High
- SHANTOU Qiwei industrial Co., Ltd — Class II recall: MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactur…
September 30, 2026·High
- Inventia Healthcare Limited — Class II recall: Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufacture…
September 23, 2026·High
- Pfizer — Class II recall: Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per t…
September 23, 2026·High
- VITRUVIAS THERAPEUTICS INC — Class I recall: Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4…
September 23, 2026·Critical
- Safecor Health, LLC — Class II recall: Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI,…
September 23, 2026·High
- Safecor Health, LLC — Class II recall: Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI,…
September 23, 2026·High
- Safecor Health, LLC — Class II recall: Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI,…
September 23, 2026·High
- Safecor Health, LLC — Class II recall: Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI,…
September 23, 2026·High
- Safecor Health, LLC — Class II recall: Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI,…
September 23, 2026·High
- SUN PHARMA /TARO — Class II recall: Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro P…
September 23, 2026·High
- Safecor Health, LLC — Class II recall: Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI,…
September 23, 2026·High
- Baxter Healthcare Corporation — Class I recall: Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporat…
September 16, 2026·Critical
- ImprimisRx NJ LLC — Class III recall: Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dro…
September 16, 2026·Medium
- Ajanta Pharma USA Inc — Class III recall: Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marke…
September 16, 2026·Medium
- OurPharma LLC — Class II recall: fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9%…
September 16, 2026·High
- B BRAUN MEDICAL INC — Class I recall: 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container…
September 16, 2026·Critical
- American Regent, Inc. — Class I recall: Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx O…
September 16, 2026·Critical
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.