Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

5876–5900 of 17974

ModerateFDA (Drugs)·D-1555-2020·2020-09-09
Jaloma Antiseptic Hand Sanitizer Recalled for cGMP Deviations
Laboratorios Jaloma is recalling 211,875 bottles of Jaloma Antiseptic Hand Sanitizer due to current Good Manufacturing Practice (cGMP) deviations.
Product
Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged in a) 16.9 Fl. Oz. (1.06 pint, 500 mL), NDC# 65055-600-02, UPC# 759684515033, b) 4 Fl. Oz.(120 mL), NDC# 65055-600-01, UPC# 75968455026, Laboratorios Jaloma S.A. DE C.V., Aquiles Serdan 438, Z.P. 44380,
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1558-2020·2020-09-09
Grato Holdings Recalls HGH Vitality Homeopathic Tablets Due to Labeling Error
Grato Holdings, Inc. is recalling 850 bottles of HGH Vitality Homeopathic tablets due to an error on the declared strength.
Product
HGH Vitality Homeopathic, 90 tablets, NDC 43742-1299-1, Dist. by Deseret Biologicals, Inc. 469 W. Parkland Drive, Sandy, UT 84070, NDC: 43742-1299-1
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-1561-2020·2020-09-09
Leiper's Fork Distillery Recalls Alcohol Antiseptic Topical Solution Due to Methanol Labeling
Leiper's Fork Distillery is recalling 1,996 gallons of 70% Ethyl Alcohol Antiseptic Topical Solution because the product is labeled to contain methanol.
Product
Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol 70%, packaged as a) 16 fluid oz./473.18 mL, bottle. b) 5 gallon vacuum sealed bucket. Leiper's Fork Distillery
Category
Drug
Distribution
1 state
CriticalFDA (Drugs)·D-1551-2020·2020-09-02
SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross Contamination
SCA Pharmaceuticals is recalling 366 containers of Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL due to cross-contamination with undeclared benzyl alcohol.
Product
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-44, Bar Code 70004065044.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1534-2020·2020-09-02
Medichem Recalls Chlorhexidine Gluconate Due to Serratia marcescens Contamination
Medichem S.A. is recalling Chlorhexidine Gluconate 0012 for manufacturing due to microbial contamination with Serratia marcescens.
Product
Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Celra, 17460, Celra, Girona (Spain/Espana); Fructuos Gelabert, 6-8, 08970, Sant Joan Despi, Barcelona (Spain/Espana) NDC 53296-0012-0
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1553-2020·2020-09-02
SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross Contamination
SCA Pharmaceuticals is recalling Heparin Sodium 10,000 units injection containers due to cross contamination with undeclared benzyl alcohol and missing parabens.
Product
Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0652-46, Bar Code 70004065246.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1552-2020·2020-09-02
SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross Contamination
SCA Pharmaceuticals is recalling Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL single-dose containers due to cross-contamination with undeclared benzyl alcohol.
Product
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-46, Bar Code 70004065046.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1550-2020·2020-09-02
SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross-Contamination
SCA Pharmaceuticals is recalling Heparin Sodium 2,500 units injection containers that contain undeclared benzyl alcohol and lack declared parabens.
Product
Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0655-44, Bar Code 70004065544.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1543-2020·2020-09-02
Bayshore Pharmaceuticals Recalls Metformin Hydrochloride Tablets Due to CGMP Deviations
Bayshore Pharmaceuticals is voluntarily recalling 594 bottles of Metformin Hydrochloride Extended-Release Tablets due to Current Good Manufacturing Practice (CGMP) deviations.
Product
METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1544-2020·2020-09-02
Bayshore Pharmaceuticals Recalls Metformin Hydrochloride Tablets Due to CGMP Deviations
Bayshore Pharmaceuticals is voluntarily recalling 3,984 bottles of Metformin Hydrochloride Extended-Release Tablets due to Current Good Manufacturing Practice (CGMP) deviations.
Product
METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1537-2020·2020-09-02
Fresenius Kabi Recalls Dexmedetomidine Injection Due to Lidocaine Contamination
Fresenius Kabi is recalling specific lots of Dexmedetomidine HCl Injection due to trace amounts of lidocaine contamination.
Product
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1535-2020·2020-09-02
Aurobindo Recalls Sulfamethoxazole and Trimethoprim Tablets Due to Metal Wire
Aurobindo Pharma USA Inc. is recalling specific lots of Sulfamethoxazole and Trimethoprim tablets because of reports of metal wire in the tablets.
Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1542-2020·2020-09-02
Par Pharmaceutical Recalls BusPIRone Hydrochloride Tablets Due to Impurity Failure
Par Pharmaceutical Inc. is recalling 11,347 bottles of BusPIRone Hydrochloride Tablets 7.5 mg because they failed impurity and degradation specifications.
Product
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-1549-2020·2020-09-02
Resource Recovery Recalls 70% Hand Sanitizer Due to cGMP Deviations
Resource Recovery & Trading LLC is recalling 115 bottles of 70% hand sanitizer distributed in Alabama and Georgia due to cGMP deviations.
Product
HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) plastic containers, Distributed by: Resource Recovery & Trading LLC 4275 Executive Square, Ste. 200 La Jolla, CA 92037, UPC 37710600013
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-1548-2020·2020-09-02
FDA Recalls Hand Sanitizer Gel Due to Manufacturing Deviations
Resource Recovery & Trading LLC is voluntarily recalling 17,280 bottles of hand sanitizer gel due to cGMP deviations. The product was distributed in Alabama and Georgia.
Product
Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (200 mL) bottles, Distributed by: Access USA, Miami, FL 33308, UPC 650240025020
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-1539-2020·2020-09-02
Ecolab Recalls Hand Sanitizer Due to Discoloration and Foreign Substance
Ecolab Inc is recalling 305 drums of 55-gallon hand sanitizer nationwide due to discoloration and the presence of a foreign substance.
Product
Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab Inc 1 EcoLab Place St. Paul, MN 55102 USA, NDC 47593-624-21
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1540-2020·2020-09-02
Rocky Mountain Sunscreen Lip Balm Recalled for Excess Octisalate
Yusef Manufacturing is recalling Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm because the active ingredient Octisalate was found at 15% above the label claim.
Product
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube, Rocky Mtn. Sunscreen, UPC 7 54018 20004 3
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-1533-2020·2020-09-02
Hikma Recalls Buprenorphine Hydrochloride Injection Due to Low Potency
Hikma Pharmaceuticals is recalling 97,890 vials of Buprenorphine Hydrochloride Injection because stability testing revealed the drug was sub-potent.
Product
BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1545-2020·2020-09-02
Hetero Labs Recalls Losartan Potassium Tablets Due to Bulging Complaints
Hetero Labs is recalling 43,512 bottles of Losartan Potassium 50 mg tablets due to a complaint of bulging tablets.
Product
Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-1541-2020·2020-09-02
Red Cross Oral Pain Relief Recalled for Cotton Pellet Labeling Error
The Mentholatum Company is recalling Red Cross Oral Pain Relief blister packs because the included cotton pellet box incorrectly lists Natural Eugenol Oil as an ingredient.
Product
RED CROSS ORAL PAIN RELIEF — RED CROSS ORAL PAIN RELIEF (BENZOCAINE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1504-2020·2020-08-26
Ferring Recalls DDAVP Nasal Spray Due to Superpotent Drug Risk
Ferring Pharmaceuticals is recalling 15,175 bottles of DDAVP Nasal Spray because the drug may be superpotent. The recall is voluntary and nationwide.
Product
DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 USA, NDC 55566-2500-0
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1506-2020·2020-08-26
Ferring Recalls STIMATE Nasal Spray Due to Superpotent Drug Risk
Ferring Pharmaceuticals is recalling 29,371 vials of STIMATE nasal spray because the drug is superpotent. The recall is voluntary and nationwide.
Product
STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap, Rx only, Manufactured for: CSL Behring LLC, King of Prussia, PA 19406-0901; By: Ferring GmbH, Kiel, Germany, NDC 0053-6871-00
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1505-2020·2020-08-26
Ferring Recalls Desmopressin Acetate Nasal Spray Due to Superpotency
Ferring Pharmaceuticals is recalling 184,325 vials of Desmopressin Acetate Nasal Spray because the drug is superpotent. The recall is voluntary and nationwide.
Product
Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap, Rx only, Manufactured for: AMRING PHARMACEUTICALS INC., Berwyn, PA 19312, NDC 69918-501-05
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1511-2020·2020-08-26
CareFusion Chlorhexidine Applicators Recalled for Non-Sterility
CareFusion 213, LLC is recalling ChlroraPrep One-Step applicators due to the presence of Aspergillus Penicilloides.
Product
ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01
Category
Medical Device
Distribution
2 states
CriticalFDA (Drugs)·D-1510-2020·2020-08-26
CareFusion Recalls ChloraPrep Applicators Due to Non-Sterility
CareFusion is recalling ChloraPrep With Tint applicators because they are not sterile and contain Aspergillus Penicilloides.
Product
ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11
Category
Medical Device
Distribution
2 states

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5876–5900 of 17974