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 the agency’s own highest classification or reported deaths or serious injuries, 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

12101–12125 of 17785

LowFDA (Drugs)·D-0856-2016·2016-05-25
Allegiant Health Recalls Col-Rite Stool Softeners for Potency Issues
Allegiant Health is recalling specific lots of Col-Rite stool softeners because they failed potency tests. Consumers should stop using the product and return it to the pharmacy.
Product
col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0854-2016·2016-05-25
Hospira Recalls Magnesium Sulfate Injection Due to pH Failures
Hospira Inc. is recalling 715,200 vials of Magnesium Sulfate Injection, USP 50% due to confirmed high out-of-specification pH results.
Product
Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0843-2016·2016-05-18
Sesderma Salises Acne Gel Recalled for cGMP Deviations
Sesderma is recalling Salises Facial Moisturizing Acne Treatment Gel due to cGMP deviations. The product does not comply with current Good Manufacturing Practice requirements.
Product
Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain --- NDC 63181-0016
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-0849-2016·2016-05-18
Sesderma Recalls Repaskin 30 Sunscreen for cGMP Deviations
Sesderma is recalling 27 bottles of Repaskin 30 Facial Sunscreen gel cream because the product does not comply with cGMP requirements.
Product
Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-0840-2016·2016-05-18
Mylan Recalls Paliperidone Extended-Release Tablets Due to Dissolution Failures
Mylan Pharmaceuticals is recalling 2,928 bottles of Paliperidone Extended-Release Tablets, 1.5 mg, because they failed dissolution specifications at a three-month stability time point.
Product
Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0847-2016·2016-05-18
Sesderma Dryses Deodorant Recalled for cGMP Deviations
Sesderma is recalling 195 bottles of Dryses Aluminum Chlorohydrate Deodorant for Women due to cGMP deviations.
Product
Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 16047-0029-1
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-0844-2016·2016-05-18
Sesderma Recalls Repaskin 50 Sunscreen Due to cGMP Deviations
Sesderma is recalling 15 tubes of Repaskin 50 sunscreen because the product does not comply with current Good Manufacturing Practice (cGMP) requirements.
Product
Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-0846-2016·2016-05-18
Sesderma Dryses Deodorant Recalled for cGMP Deviations
Sesderma is recalling Dryses Aluminum Chlorohydrate Deodorant for Men because the product does not comply with cGMP requirements.
Product
Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0019-1 UPC 8 470002 075221
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-0842-2016·2016-05-18
Sesderma Recalls Dryses Antiperspirant Solution for cGMP Deviations
Sesderma is recalling 542 bottles of Dryses Aluminum Chlorohydrate Antiperspirant Solution because the product does not comply with cGMP requirements.
Product
Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0015-1, UPC 8 470003 244268
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-0852-2016·2016-05-18
Baxter Recalls Brevibloc Injection Due to Yellow Discoloration
Baxter Healthcare is recalling Brevibloc (esmolol hydrochloride) injection because the solution shows atypical yellow discoloration. The recall covers 11,630 units distributed nationwide.
Product
BREVIBLOC — BREVIBLOC (ESMOLOL HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0850-2016·2016-05-18
Sesderma Sunscreen Recalled for cGMP Deviations
Sesderma is recalling 45 compacts of Screenses Color Sunscreen due to cGMP deviations. The product is distributed in Florida, Puerto Rico, Colorado, and Georgia.
Product
Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252166
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-0848-2016·2016-05-18
Sesderma Recalls Repaskin 50 Sunscreen for cGMP Deviations
Sesderma is recalling 66 bottles of Repaskin 50 sunscreen due to cGMP deviations. The product was distributed to Florida, Puerto Rico, Colorado, and Georgia.
Product
Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0011-1
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-0851-2016·2016-05-18
Sesderma Sunscreen Recalled for cGMP Non-Compliance
Sesderma is recalling 44 compacts of Screenses Color Sunscreen due to cGMP deviations. The product is distributed in Florida, Puerto Rico, Colorado, and Georgia.
Product
Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252159
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-0845-2016·2016-05-18
Sesderma Recalls Repaskin 30 Sunscreen for cGMP Deviations
Sesderma is recalling 20 bottles of Repaskin 30 sunscreen due to cGMP deviations. The product is distributed in Florida, Puerto Rico, Colorado, and Georgia.
Product
Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 30, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0012-1 UPC8 429979 415691
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-0841-2016·2016-05-18
Dr. Reddy's Recalls Ondansetron Tablets Due to Failed Impurity Specifications
Dr. Reddy's Laboratories is recalling 50,280 bottles of Ondansetron Tablets USP, 4 mg, due to failed impurities and degradation specifications.
Product
Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0837-2016·2016-05-11
Bryant Ranch Recalls Venlafaxine Tablets Due to Labeling Error
Bryant Ranch Prepack Inc. is recalling venlafaxine hydrochloride extended-release tablets that were incorrectly labeled as immediate-release.
Product
VENLAFAXINE — VENLAFAXINE (VENLAFAXINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0838-2016·2016-05-11
VistaPharm Recalls Oxycodone Hydrochloride Oral Solution Due to Defective Container Seals
VistaPharm is recalling 8,901 cases of Oxycodone Hydrochloride Oral Solution because defective container seals may allow the medication to leak.
Product
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (NDC 66689-401-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0835-2016·2016-05-11
Akorn Recalls PEG-Phen Lubricant Eye Drops Due to Particulate Matter
Akorn, Inc. is recalling specific batches of PEG-Phen Lubricant Eye Drops because they contain particulate matter. Consumers should stop using the affected products.
Product
Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-199-05, ALSO labeled as Premier Value Brand PEG-Phen Lubricant Eye…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0839-2016·2016-05-11
A-S Medication Solutions Recalls Acetaminophen and Codeine Tablets Due to Labeling Error
A-S Medication Solutions LLC is recalling 2,730 bottles of Acetaminophen & Codeine Phosphate Tablets because the count on the label was incorrect.
Product
Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0
Category
Drug
Distribution
1 state
LowFDA (Drugs)·D-0836-2016·2016-05-11
Hospira Recalls Quelicin Injection Due to Faded or Missing Label Dates
Hospira Inc. is recalling 103,600 vials of Quelicin (Succinylcholine Chloride) Injection because the lot number or expiration date may be faded or missing from the primary label.
Product
QUELICIN — QUELICIN (SUCCINYLCHOLINE CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0834-2016·2016-05-04
SKY Aspirin Chewable Tablets Recalled for Incorrect Outer Carton Labeling
McKesson Packaging Services is recalling SKY Aspirin Chewable Tablets because the outer cartons were incorrectly labeled. The recall addresses a labeling mix-up.
Product
SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0825-2016·2016-04-27
Impax Recalls Dextroamphetamine Sulfate Tablets Due to Failed Impurity Specifications
Impax Laboratories is recalling 67,428 bottles of Dextroamphetamine Sulfate Tablets USP, 10 mg, because the product failed impurities and degradation specifications.
Product
Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0832-2016·2016-04-27
Hospira Recalls Potassium Chloride Injection Bags Due to Chemical Contamination
Hospira Inc. is recalling 81,888 bags of Potassium Chloride Injection due to potential contamination with an aromatic hydrocarbon resin.
Product
Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7077-14
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0828-2016·2016-04-27
Hospira Recalls Dextrose Injection Bags Due to Chemical Contamination
Hospira Inc. is recalling 4,368 bags of Dextrose Injection, USP, 50% due to potential contamination with an aromatic hydrocarbon resin.
Product
Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7936-19, Barcode (01) 0 030409 793619 9
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0829-2016·2016-04-27
Hospira Recalls Dextrose Injection Bags Due to Chemical Contamination Risk
Hospira Inc. is recalling 552 bags of Dextrose Injection, USP, 20% due to potential contamination with an aromatic hydrocarbon resin.
Product
Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7935-19, Barcode (01) 0 030409 793519 2
Category
Drug
Distribution
Distributed nationwide

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12101–12125 of 17785