The Recall Desk

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.

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12301–12325 of 18028

  • ModerateFDA (Drugs)·D-0857-2016·2016-06-01

    Pfizer Recalls Zoloft Tablets Due to Thick Tablet Specifications

    Pfizer is recalling 68,214 bottles of Zoloft 100 mg tablets because some tablets were thicker than specifications. The recall covers nationwide distribution and Puerto Rico.

    Product
    Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0875-2016·2016-06-01

    Akorn Recalls Chlorhexidine Gluconate Oral Rinse Due to Unknown Impurity

    Akorn, Inc. is recalling Chlorhexidine gluconate oral rinse due to an out-of-specification result for an unknown impurity.

    Product
    Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0853-2016·2016-05-25

    Keystone Recalls Better Braid Un-Braid Due to Microbial Contamination

    Keystone Laboratories is recalling Better Braid Un-Braid salicylic acid product due to a failed S. aureus test. The product was distributed in Maryland and New Jersey.

    Product
    BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEYSTONE LABORATORIES, UPC 07059600430.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0855-2016·2016-05-25

    Renovo Patch Recalled for Lack of Approval and Subpotency

    TMIG Inc is recalling Renovo Patch because it was marketed without FDA approval and three lots were found to be subpotent.

    Product
    Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta , GA 30062, Manufactured By: Pocono Coated Products LLC., Cherryville, NC 28021 NDC: 69176-025-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (Food)·F-1163-2016·2016-05-11

    Iowa Select Herbs Recalls Cold Be Gone for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Cold Be Gone products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Cold Be Gone, www.iowaselectherbs.com, (a) 1/2 fl. Oz., (b) 15 ml, (c) 1 fl. Oz., (d) 30 ml (e) unknown size, Cedar Rapids, IA 52402
    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