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FDA food · drug · device recalls, merged

Before you eat it, take it, or plug it in — check.

Big Nope pulls three separate FDA recall feeds into one list per state, so you’re not searching three government databases to get one answer.

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded

Recalls nationwide

Data last updated: September 6, 2026 at 10:21 PM UTC

19,229 recalls found
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled February 2, 2012

VITROS Chemistry Products --- ALT Slides --- [REF] 165 5281 --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA. The recalled device is the calibration disk contained within the VITROS Calibrator Kit 3. The is can be identified with the label "VITROS Chemist y Systems --- Universal Calibration Diskette --- [REF] 871 6607 --- Ortho-Clinical Diagnostics" For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 3 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of AcP, ALT, ALKP, AMYL, AST, CK, GGT, LDH, and LIPA.

Ortho Clinical Diagnostics received complaints of lower than expected results (< 6 U/L) for samples that were known to be outside of the measuring (reportable) range (> 1000 U/L) when using Calibration Diskette/Assay Data Diskette Data Release Version (DRV) 5653 through 5666 and VITROS Chemistry Products ALT Slides, Generation (GEN) 26 (Product Code 1655281).

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
61175
Lot/product code:
Calibration Diskette (Product Code 8716607) and the Assay Data Diskette (Product Code 6801876), Data Release Version (DRV) 5653 through 5666 used in conjuction with of VITROS¿ Chemistry Products ALT Slides, Generation (GEN) 26 (Product Code 1655281).
Recalling firm:
Ortho-Clinical Diagnostics
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled March 10, 2012

Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS

Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug

Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-266-2013
Lot/product code:
None
Recalling firm:
The Menz Club, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2012

Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy, developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengths in 4 mm increments. They are 30 mm, 34 mm, 38 mm and 42 mm. They come in multiple neck angles and versions in each length. They are 127, 130 and 132. The versions are 0, 8, 16 degrees. In total there are 16 unique neck implants in the Rejuvenate Modular System.

Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and or corrosion at or about the modular neck junction. On June 29, 2012, Stryker has decided to remove the affected product from the field since there may be an

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
62456
Lot/product code:
510 K092561 all lots Rejuvenate (NLS/NLV) Rejuvenate (SPT) (4845-4XXX and NLS/NLV)
Recalling firm:
Stryker Howmedica Osteonics Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2012

ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.

Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and or corrosion at or about the modular neck junction. On June 29, 2012, Stryker has decided to remove the affected product from the field since there may be an

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
62456
Lot/product code:
510 K092406  all lots  (4845-4XXX and NLS/NLV)
Recalling firm:
Stryker Howmedica Osteonics Corp.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled September 10, 2012

HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21

Stronger than it should be (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in stronger than it should be assays of both the hydrocodone and acetaminophen components.

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-057-2013
Lot/product code:
Lot number: C1440512A, Exp 12/13
Recalling firm:
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 12, 2012

Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined that the incorrect insert was used which indicates that the device is MR Safe, when it is actually MR Conditional.

Full report

FDA has not published a risk classification for this recall yet.

Recall #:
65669
Lot/product code:
Part Number 390.007, Lot Number 6800599
Recalling firm:
Synthes USA HQ, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 9, 2012

Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.

Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
63709
Lot/product code:
PIIC 865435 M3140 Information Center Low Acuity 865436 M3150 Information Center Local DB 865417 M3145 Information Center Small NW DB 865418 M3155 Information Center NW DB 865415 M3151 Information Center Client 865421 M3170 Patient Link 865416 M3177 Trend Display 865422 M3140 Upgrade 865423 M3150 Upgrade 865426 M3145 Upgrade 865427 M3155 Upgrade 865424 M3151 Upgrade 865266 - M3140 Information Center Low Acuity 865267 M3150 Information Center Local DB 865269 M3145 Information Center Small NW DB 865268 M3155 Information Center NW DB 865270 M3151 Information Center Client 865274 M3170 Patient Link 865271 M3177 Trend Display 865277 M3140 Upgrade 865278 M3150 Upgrade 865281 M3145 Upgrade 865282 M3155 Upgrade 865279 M3151 Upgrade  PIIC iX 866023 IntelliVue Info Center iX 866117 PIIC Classic Upgrade 866027 PIIC iX HW Upgrade
Recalling firm:
Philips Healthcare Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles ( NDC 60793-853-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

Chemical contamination: emission of strong odor after package was opened..

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-254-2013
Lot/product code:
Lot # a) 66619B, Exp. 11/13; 67010B, Exp. 01/14; b) 66733B, Exp. 11/13; 67441B, Exp. 01/14
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles ( NDC 60793-858-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

Chemical contamination: emission of strong odor after package was opened.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-259-2013
Lot/product code:
Lot # a) 66375B, Exp. 10/13; 66719B, Exp. 01/14; b) 66904B, Exp. 01/14
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles ( NDC 60793-852-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

Chemical contamination: emission of strong odor after package was opened.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-253-2013
Lot/product code:
Lot # a) 66369B, Exp. 10/13; 66679B, Exp. 11/13; 66850B, Exp. 12/13; b) 66676B, 66732B, Exp. 12/13; 67136B, Exp. 03/14
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles ( NDC 60793-859-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

Chemical contamination: emission of strong odor after package was opened.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-260-2013
Lot/product code:
Lot # a) 67507B, Exp. 02/14; b) 67508B, Exp. 02/14
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles ( NDC 60793-860-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

Chemical contamination: emission of strong odor after package was opened.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-261-2013
Lot/product code:
Lot # a) 66671B, Exp. 11/13; 67512B, Exp. 02/14 b) 66739B Exp. 11/13; 67513B Exp. 02/14
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles ( NDC 60793-851-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

Chemical contamination: emission of strong odor after package was opened.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-252-2013
Lot/product code:
Lot # a) 66730B, 66853B, Exp. 01/14; b) 66731B, 67116B, Exp. 11/13, 66856B, Exp. 12/13; 67341B, Exp, 02/14
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles ( NDC 60793-854-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

Chemical contamination: emission of strong odor after package was opened..

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-255-2013
Lot/product code:
Lot # a) 66897B, Exp. 12/13; b) 67137B, Exp.02/14
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles ( NDC 60793-855-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

Chemical contamination: emission of strong odor after package was opened.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-256-2013
Lot/product code:
Lot # a) 67343B, Exp. 01/14; b) 66902B, Exp. 12/13
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles ( NDC 60793-856-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

Chemical contamination: emission of strong odor after package was opened

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-257-2013
Lot/product code:
Lot # a) 66373B, Exp. 10/13; 66851B, Exp. 12/13; b)66792B, Exp. 12/13; 67349B, Exp. 03/14
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles ( NDC 60793-850-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

Chemical contamination: emission of strong odor after package was opened..

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-251-2013
Lot/product code:
Lot # a) 66675B, Exp. 10/13; b) 66852B Exp. 10/13; 67138B, Exp. 02/14
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 28, 2013

Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles ( NDC 60793-857-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

Chemical contamination: emission of strong odor after package was opened.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-258-2013
Lot/product code:
Lot # a) 67013B, Exp. 01/14; b) 66900B, Exp. 01/14
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2013

Bi mix, compounded by Olympia Pharmacy, Orlando, FL

Not guaranteed to be germ-free: FDA inspection findings resulted in concerns regarding quality control processes

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-706-2013
Lot/product code:
A5028 Exp 6/2/13, B5011 exp 6/1/13, C4112 Exp 6/1/13, and C4208 Exp 6/20/13
Recalling firm:
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2013

Sodium Tetradecyl Sulfate (0.125%, 1%, 2.5%, 3%, and 4%) Injection, compounded by Olympia Pharmacy, Orlando, FL

Not guaranteed to be germ-free: FDA inspection findings resulted in concerns regarding quality control processes

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-782-2013
Lot/product code:
0.125% Lot B3505 Exp 8/1/13 // 1% Lots C5001 Exp 9/30/13, C5406 Exp 9/4/13, and C5306 Exp 9/30/13 // 2.5% Lot C5101 Exp 9/30/13 // 3% Lots B5120 Exp 10/31/13, C5301 Exp 9/30/13, B5428 Exp 6/4/13, and C5212 Exp 9/21/13 // 4% Lot C5301 Exp 9/30/13
Recalling firm:
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2013

Phenobarbital 62. 5mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

Not guaranteed to be germ-free: FDA inspection findings resulted in concerns regarding quality control processes

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-769-2013
Lot/product code:
B5128 Exp 8/28/13
Recalling firm:
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2013

Guanabenz 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

Not guaranteed to be germ-free: FDA inspection findings resulted in concerns regarding quality control processes

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-738-2013
Lot/product code:
A0422 Exp 7/31/13
Recalling firm:
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2013

Vitamin B12 (3000 mcg/ml & 5000 mcg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL

Not guaranteed to be germ-free: FDA inspection findings resulted in concerns regarding quality control processes

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-791-2013
Lot/product code:
B0020 Exp 8/20/13 and C31011 Exp 9/10/13
Recalling firm:
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2013

Oxytocin 20 units/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

Not guaranteed to be germ-free: FDA inspection findings resulted in concerns regarding quality control processes

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-764-2013
Lot/product code:
B5019 Exp 10/31/13, B3525 Exp 8/25/13 and B3122 Exp 8/22/13
Recalling firm:
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 29, 2013

Enrofloxacin 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

Not guaranteed to be germ-free: FDA inspection findings resulted in concerns regarding quality control processes

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-726-2013
Lot/product code:
A5011 Exp 11/30/13
Recalling firm:
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
View official FDA record (opens in a new tab)