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
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).
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
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Harrow Eye LLC
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
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
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
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
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
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
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
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)
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
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.
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.
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.
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.
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.
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
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
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipl…
Cipla USA, Inc.
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.
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.
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.
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
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
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipl…
Cipla USA, Inc.
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.
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
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.
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
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.
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
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.
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.
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.
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.
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.
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.
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.
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
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipl…
Cipla USA, Inc.
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.
Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonf…
Avantor Performance Materials LLC
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.
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.
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.
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
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.
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.
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.
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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Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Consult a qualified professional before making decisions based on this data.
- Source: FDA Drug Safety — verify with the issuing agency: official recall page →
- Source: PlainRecalls Data Index — aggregated from FDA openFDA, CPSC, and NHTSA public databases
Read our methodology — how this data is sourced, computed, and verified.