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FDA Drug Safety

All recall actions attributed to FDA Drug Safety in our federal database. Each record links back to the agency's official notice so you can verify status, remedy, and amendments before acting.

U.S. Food and Drug Administration — Drug recalls and safety communications

17,683 recalls · Page 2 of 354

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FDA Drug Safety Recall Insight

PlainRecalls tracks 17,683 recall actions attributed to the FDA Drug Safety in our federal recall index. Across the full PlainRecalls database of 83,949 records spanning 1995 through 2026, FDA Drug Safety accounts for roughly 21.1% of all indexed recalls. The agency's stated scope — U.S. Food and Drug Administration — Drug recalls and safety communications — determines what classes of products flow through its recall pipeline and how quickly notices reach consumers. With 354 pages of records at 50 recalls per page, this archive represents one of the longest continuous federal enforcement histories accessible to the public.

Looking at the 50 records on this page alone, the severity distribution skews toward 0 critical (Class I-equivalent) actions, 45 moderate recalls, and 5 lower-severity notices. Approximately 50 of 50 entries name a specific recalling firm, while 50 disclose a unit count — the gap reflects regulatory filing norms where firms disclose lot numbers or distribution channels instead of absolute quantities. This page spans recalls from Apr 15, 2026 to Apr 29, 2026, covering 19 distinct firms. Severity mix is a leading indicator: a page weighted toward critical classifications usually signals an active public-health concern, while lower-severity clusters often represent labeling, undeclared-allergen, or minor design corrections.

Agency-level browsing is useful when a defect pattern crosses categories — for example, a supplier contamination can trigger dozens of downstream recalls that share no obvious product tag but a single issuing agency. Use the pagination below to scan the full archive, or combine this agency filter with category and manufacturer views elsewhere on PlainRecalls to intersect the data. Recall records are sourced directly from FDA Drug Safety's public enforcement feeds and are updated as the agency publishes new notices; the federal record is the authoritative version, and this page aggregates what the agency itself has released. For high-stakes decisions — medical, automotive, or childcare — always click through to the recall detail page and cross-verify the recall number against the agency's current site. Record counts reflect all indexed actions regardless of status (ongoing, terminated, or completed).

Moderate Apr 29, 2026

Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Maj…

The Harvard Drug Group LLC

Moderate Apr 29, 2026

FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.

Harrow Eye LLC

Moderate Apr 29, 2026

DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.

B BRAUN MEDICAL INC

Moderate Apr 29, 2026

Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01

Leading Pharma, LLC

Low Apr 29, 2026

Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA…

Premier Dental Products Co

Moderate Apr 29, 2026

LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.

B BRAUN MEDICAL INC

Moderate Apr 29, 2026

Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-coun…

Teva Pharmaceuticals USA, Inc

Moderate Apr 29, 2026

0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.

B BRAUN MEDICAL INC

Moderate Apr 29, 2026

Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.

B BRAUN MEDICAL INC

Moderate Apr 29, 2026

Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ …

Hetero Labs Limited (Unit V)

Moderate Apr 22, 2026

Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceutica…

SUN PHARMACEUTICAL INDUSTRIES INC

Moderate Apr 22, 2026

MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medical Group Care, LLC, 1035 Collie…

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Moderate Apr 22, 2026

FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made…

Owen Biosciences Inc.

Moderate Apr 22, 2026

MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By: Medical Group Care, LLC,…

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Moderate Apr 22, 2026

Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio 4…

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Moderate Apr 22, 2026

exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag, Manufactured for Your Military Exchanges B…

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Low Apr 22, 2026

Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13

Island Kinetics, Inc. d.b.a. CoValence Laboratories

Moderate Apr 22, 2026

Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR

PAYLESS COMPOUNDERS, LLC

Moderate Apr 22, 2026

Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipl…

Cipla USA, Inc.

Moderate Apr 22, 2026

Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apote…

Apotex Corp.

Moderate Apr 22, 2026

EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceu…

International Medication Systems Ltd.

Moderate Apr 22, 2026

SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Brands, Culver City, CA90232.

Owen Biosciences Inc.

Low Apr 22, 2026

Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHO…

Island Kinetics, Inc. d.b.a. CoValence Laboratories

Moderate Apr 22, 2026

Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceutica…

SUN PHARMACEUTICAL INDUSTRIES INC

Moderate Apr 22, 2026

Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipl…

Cipla USA, Inc.

Moderate Apr 22, 2026

QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon Flavor, 25-count bag, Distributed By: CDMA, Inc., …

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Moderate Apr 22, 2026

Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600…

Nephron SC, LLC

Moderate Apr 22, 2026

Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey Lemon, 30-count bag, Distributed By: Drug Mart-Food Fair, M…

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Moderate Apr 22, 2026

Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceutica…

SUN PHARMACEUTICAL INDUSTRIES INC

Moderate Apr 22, 2026

QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 4837…

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Moderate Apr 22, 2026

Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceu…

The Harvard Drug Group LLC

Moderate Apr 22, 2026

QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Black Cherry Flavor, 25-count bag, Distributed By: CDMA, Inc.…

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Moderate Apr 22, 2026

QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawberry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, …

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Moderate Apr 22, 2026

exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Manufactured for Your Military Exchanges By: …

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Moderate Apr 22, 2026

QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48…

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Moderate Apr 22, 2026

SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Ski…

Owen Biosciences Inc.

Moderate Apr 22, 2026

caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc., 5473 Blair Rd, Suite 100, …

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Moderate Apr 22, 2026

0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmingt…

Huons Co., Ltd.

Low Apr 22, 2026

Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airpor…

Island Kinetics, Inc. d.b.a. CoValence Laboratories

Moderate Apr 22, 2026

Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipl…

Cipla USA, Inc.

Moderate Apr 22, 2026

Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio…

Huons Co., Ltd.

Low Apr 22, 2026

Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonf…

Avantor Performance Materials LLC

Moderate Apr 22, 2026

Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 7…

Huons Co., Ltd.

Moderate Apr 22, 2026

QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, M…

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Moderate Apr 22, 2026

HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottle; DIST BY HYDROPEPTIDE LLC, ISSAQUAH, WA 98027

Owen Biosciences Inc.

Moderate Apr 22, 2026

Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.

Island Kinetics, Inc. d.b.a. CoValence Laboratories

Moderate Apr 22, 2026

MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical Group Care, LLC, 1035 Collie…

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Moderate Apr 22, 2026

Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheo…

Huons Co., Ltd.

Moderate Apr 22, 2026

QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi MI 48375, M…

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

Moderate Apr 15, 2026

Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266…

Fagron Compounding Services

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