The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

17976–18000 of 21645

  • ModerateFDA (Drugs)·D-1522-2014·2014-08-13

    FDA Recalls Unapproved Vitamin B12 Injection Vials Nationwide

    Medical Supply Liquidators LLC is recalling Vitamin B12 Cyanocobalamin Injection vials because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.

    Product
    Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2144-2014·2014-08-13

    Zimmer Recalls Tapered Screw-Vent Dental Implant Due to Labeling Error

    Zimmer, Inc. is recalling Tapered Screw-Vent Dental Implants because the inner vial is labeled with incorrect dimensions.

    Product
    Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2147-2014·2014-08-13

    Boston Scientific recalls 21 ENDOTAK RELIANCE defibrillation leads due to test errors

    Boston Scientific is recalling 21 ENDOTAK RELIANCE defibrillation leads because manufacturing test records showed suspected data recording errors. No injuries have been reported.

    Product
    Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1513-2014·2014-08-13

    Wockhardt Recalls BuPROPion HCl Extended-Release Tablets Due to Impurity Levels

    Wockhardt USA is recalling 840 bottles of buPROPion HCl Extended-Release Tablets because out-of-specification levels of the impurity m-chlorobenzoic acid were observed.

    Product
    buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1510-2014·2014-08-13

    Caraco Recalls Cephalexin Capsules Due to Manufacturing Deviations

    Caraco Pharmaceutical is recalling Cephalexin Capsules, 250 mg, because the active ingredients were not manufactured with good manufacturing practices.

    Product
    Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1527-2014·2014-08-13

    FDA Recalls Unapproved Vitamin B12 Injection Vials Nationwide and Abroad

    Medical Supply Liquidators LLC is recalling Vitamin B12 Cyanocobalamin injections because the manufacturer is not FDA-registered and the product lacks an approved NDA or ANDA.

    Product
    Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml, packaged in 10 ml vials and 30 ml vials, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1525-2014·2014-08-13

    Medical Supply Liquidators Recalls Unapproved MIC Injection Vials

    Medical Supply Liquidators LLC is recalling MIC Injection USP vials because the manufacturer is not registered with the FDA and the product lacks an approved NDA/ANDA.

    Product
    MIC Injection USP, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1517-2014·2014-08-13

    SST Corporation Recalls Tetrahydrozoline HCL Due to CGMP Deviations

    SST Corporation is recalling Tetrahydrozoline HCL drums because they were stored in a non-GMP compliant warehouse in Italy.

    Product
    Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2150-2014·2014-08-13

    Siemens ADVIA Centaur CP BNP Kit Recalled for Failed Calibration

    Siemens Healthcare Diagnostics is recalling 961 BNP kits due to complaints of failed calibration. The kits are used for in vitro diagnostic testing of B-type Natriuretic Peptide.

    Product
    SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2305-2014·2014-08-13

    Beirut Lift Turnip Pickles Recalled for Undeclared Dyes

    Baroody Imports Inc. is recalling Beirut Lift Turnip Pickles because the product contains undeclared FD & C Red #40 and unallowable dye Rhodamine B.

    Product
    Beirut Lift Turnips Pickles, Net Wt. 24.66 oz., 700g, Imported & Distributed By: Baroody Import Inc., 1500 B Main Ave. Clifton, NJ 07011, N DC #642036014141 in a sealed glass jar.
    Category
    Food
    Distribution
    1 state
  • ModerateUSDA FSIS·052-2014·2014-08-12

    Applegate Recalls Chicken Nuggets Due To Possible Plastic Contamination

    Applegate is recalling frozen chicken nuggets due to possible plastic contamination. No illnesses or injuries have been reported.

    Product
    Gold Creek Foods, LLC — Georgia Firm Recalls Chicken Nugget Product Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1487-2014·2014-08-06

    Dermamedics Post Procedure Cream Recalled for Lack of FDA Approval

    Dermamedics, L.L.C. is recalling Post Procedure Cream because the FDA determined the product is an unapproved new drug and misbranded.

    Product
    Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1508-2014·2014-08-06

    Daiichi Sankyo Recalls Benicar HCT Tablets Due to Temperature Abuse

    Daiichi Sankyo is recalling specific lots of Benicar HCT tablets because they were not stored at controlled room temperature during shipping.

    Product
    Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-107-30 and NDC 65597-107-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2247-2014·2014-08-06

    GM Manufacturing Recalls Adam Blister Pack Dietary Supplements

    GM Manufacturing is recalling 9,500 units of Adam Blister Packs dietary supplements distributed in California due to significant cGMP violations.

    Product
    Adam, Blister Packs
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2242-2014·2014-08-06

    GM Manufacturing Recalls Tiger-X Blister Packs for cGMP Violations

    GM Manufacturing is recalling 11,218 units of Tiger-X dietary supplements in California due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Tiger-X, Blister Packs
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1483-2014·2014-08-06

    McKesson Recalls Aspirin DR Tablets for Dissolution Failure

    McKesson Packaging Services is recalling Aspirin DR Enteric Coated Tablets because they failed to meet dissolution specifications at the 12-month time interval.

    Product
    Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2124-2014·2014-08-06

    DeRoyal Knee Arthroscopy Pack Recalled Due to Component Recall

    DeRoyal Industries is recalling 128 Knee Arthroscopy Packs because they contain Irrigation Sets previously recalled by Hospira.

    Product
    DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-1505-2014·2014-08-06

    Daiichi Sankyo Recalls Welchol Tablets Due to Temperature Abuse During Shipping

    Daiichi Sankyo is recalling 68 bottles of Welchol Tablets (colesevelam HCl) 625 mg because they were not stored at controlled room temperature during shipping.

    Product
    Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1495-2014·2014-08-06

    Dermamedics Recalls Unapproved Therametics Complexion Repair Topical Emulsion

    Dermamedics, L.L.C. is recalling Therametics Complexion Repair Topical Rehydrating Emulsion because the FDA determined the products are unapproved new drugs and misbranded.

    Product
    Therametics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Complexion Repair Acne Treatment System Kit and the Complexion Repair Acne Travel Kit with SKU numbers of CR1005 and CR1007, respectively.
    Category
    Drug
    Distribution
    Distributed nationwide