UnclassifiedAnnounced September 4, 2026
Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement
Products contain undeclared yohimbine
Read FDA’s announcement (opens in a new tab)Recalls affecting North Carolina
Data last updated: September 6, 2026 at 11:49 PM UTC
17,100 recalls foundJust announced
Straight from FDA press releases — not yet formally classified or risk-gradedUnclassifiedBacteria/virusAnnounced September 4, 2026
Foods Alive — Moringa Leaf Powder
Potential to be contaminated with Salmonella
Read FDA’s announcement (opens in a new tab)UnclassifiedAnnounced September 3, 2026
B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container
Presence of particulate matter identified as iron oxide
Read FDA’s announcement (opens in a new tab)UnclassifiedBacteria/virusAnnounced September 3, 2026
Great Value — Organic Triple Berry Blend
Possible E. Coli Contamination
Read FDA’s announcement (opens in a new tab)UnclassifiedAnnounced September 3, 2026
American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial
Presence of particulate matter and lack of sterility assurance
Read FDA’s announcement (opens in a new tab)UnclassifiedAnnounced August 31, 2026
Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement
Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)
Read FDA’s announcement (opens in a new tab)UnclassifiedAnnounced August 31, 2026
Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml
Contains garlic essential oil not approved for culinary use
Read FDA’s announcement (opens in a new tab)UnclassifiedAllergenAnnounced August 31, 2026
Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.
Undeclared milk
Read FDA’s announcement (opens in a new tab)UnclassifiedBacteria/virusAnnounced August 29, 2026
Everything Sprouts — Robust Radish Mix, 5oz Cups
Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.
Read FDA’s announcement (opens in a new tab)UnclassifiedBacteria/virusAnnounced August 29, 2026
Martina — Mangoes
Potential contamination with Salmonella
Read FDA’s announcement (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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Class IIModerate risk
DrugRecalled May 29, 2013
BNP/Dexamethasone Eye Ointment, 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-707-2013
- Lot/product code:
- B5119 exp 10/31/13
- Recalling firm:
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Class IIModerate risk
DrugRecalled May 29, 2013
Disodium EDTA 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-724-2013
- Lot/product code:
- A5616 Exp 7/31/13
- Recalling firm:
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Class IIModerate risk
DrugRecalled May 29, 2013
Clenbuterol 0.03mg/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-714-2013
- Lot/product code:
- A0107 Exp 01/31/14
- Recalling firm:
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Class IIModerate risk
DrugRecalled May 29, 2013
Caco/Copper 6. 2 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-709-2013
- Lot/product code:
- L5610 exp 11/30/13
- Recalling firm:
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Class IIModerate risk
DrugRecalled May 29, 2013
Quadmix, 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-778-2013
- Lot/product code:
- C4526 Exp 9/4/13, B4125 exp 8/12/13, and B5014 exp 8/1/13
- Recalling firm:
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Class IIModerate risk
DrugRecalled May 29, 2013
Voriconazole 5% Ophthalmic drop 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-794-2013
- Lot/product code:
- A5615 Exp 6/6/13
- Recalling firm:
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Class IIModerate risk
DrugRecalled May 29, 2013
Miconazole 3% 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-761-2013
- Lot/product code:
- B5001 Exp 6/1/13
- Recalling firm:
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Class IIModerate risk
DrugRecalled May 29, 2013
Naproxen 100 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-762-2013
- Lot/product code:
- K5013 Exp 11/30/13
- Recalling firm:
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Class IIModerate risk
DrugRecalled May 29, 2013
Pentosan 250 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-768-2013
- Lot/product code:
- K5629 Exp 11/30/13, C51013 Exp 9/10/13 and C5513 Exp 9/14/13
- Recalling firm:
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Class IIModerate risk
DrugRecalled May 29, 2013
Furosemide 50 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-730-2013
- Lot/product code:
- A5029 Exp 11/30/13
- Recalling firm:
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy