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Use caution Drug recall · FDA · Published March 25, 2016

Recall: Reliable Rexall Potassium Bromide Due to Processing Issues

Reliable Rexall-A Compounding Pharmacy recalls all potassium bromide products compounded between March 2015 and March 2016 due to lack of processing controls.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1135-2016DrugReliable Rexall-A Compounding Pharmacy ›
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Contact the company

Recalling firmReliable Rexall-A Compounding Pharmacy801 Irving St · San Francisco, CA 94122-2310
✎ GovInfoNow plain-language explainer

What happened, in plain English

Reliable Rexall-A Compounding Pharmacy is recalling all potassium bromide products compounded by their San Francisco location. The recall covers all lots produced between March 24, 2015, and March 24, 2016, provided they are within their expiry date. This action was taken because the pharmacy lacked necessary processing controls during that period. Read more at govinfonow.com/recall/43025-recall-reliable-rexall-potassium-bromide-due-to-processing-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/43025-recall-reliable-rexall-potassium-bromide-due-to-processing-issues · Updated October 11, 2026 · FDA enforcement record: FDA #D-1135-2016

Cite this page

“Recall: Reliable Rexall Potassium Bromide Due to Processing Issues.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43025-recall-reliable-rexall-potassium-bromide-due-to-processing-issues. Based on FDA recall #D-1135-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1135-2016%22&limit=1).

Why it’s dangerous

The recall is due to a lack of processing controls, which means the manufacturing process did not follow standard quality assurance protocols. While the specific health risks are not detailed in this record, the absence of these controls could affect the consistency or safety of the compounded medication.

Who’s affected

Patients who received prescription potassium bromide from Reliable Rexall-A Compounding Pharmacy in San Francisco, California, between March 2015 and March 2016. The products were distributed to customers in the U.S., including California, Hawaii, and New Mexico.

How to tell if you have this one

Check if you have potassium bromide products compounded by Reliable Rexall-A Compounding Pharmacy (Reliable Drug) located at 801 Irving St., San Francisco, CA. Look for lots compounded between March 24, 2015, and March 24, 2016, that are still within their expiry date.

  • Brand
    Reliable Rexall-A Compounding Pharmacy
  • Category
    Drug
FDA recall event · 70 products

All 70 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Status
    Terminated
  • Distribution
    U.S. Including: CA, HI, NM
Recall numberProduct, codes & lotsClass
D-1067-2016All 4-aminopyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1068-2016CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class I
D-1069-2016All testosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1070-2016All estriol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1071-2016All TRIE Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1072-2016All Peterson Cream Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1073-2016All progesterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry..Class II
D-1074-2016All carbomer Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1075-2016All monobenzone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1076-2016All betamethasone diproprionate Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1077-2016All Germall (diazolidinyl urea and iodopropynyl butylcarbamate) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1078-2016All fluocinonide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1079-2016All methimazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1080-2016All propylparaben Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1081-2016All tetracaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1082-2016All PCCA Lipoderm Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1083-2016All thymol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1084-2016All T4-levothyroxine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1085-2016All arginine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1086-2016All cetirizine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry..Class II
D-1087-2016All budesonide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1088-2016All hydroxyzine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1089-2016All quinine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1090-2016All citalopram Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1091-2016All fluoxymesterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1092-2016All minocycline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1093-2016All lidocaine/tetracaine/benzocaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1094-2016All boric acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1095-2016All Stanford Magic Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry..Class II
D-1096-2016All Jack Newman Cream Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1097-2016All hydrocortisone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1098-2016All spironolactone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1099-2016All naltrexone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1100-2016All nifedipine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1101-2016All melatonin Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1102-2016All triamcinolone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1103-2016All lidocaine, meloxicam, diclofenac and baclofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1104-2016All thyroid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1105-2016All T3 Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1106-2016All mirtazapine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1107-2016All ketoprofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1108-2016All squaric acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1109-2016All sulfapyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1110-2016All Midrin (isometheptene mucate, dichloralphenazone and acetaminophen) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1111-2016All retinoic acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1112-2016All Coal Tar Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1113-2016All phenylephrine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1114-2016All Arimidex (anastrozole) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1115-2016All quinacrine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1116-2016All capsicum Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1117-2016All cocaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1118-2016All diltiazem Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1119-2016All hydroxyurea Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1120-2016All acyclovir and lidocaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1121-2016All fluconazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1122-2016All sucralfate Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1123-2016All doxycycline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1124-2016All dyclonine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1125-2016All estradiol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1126-2016All ketamine and amitriptyline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1127-2016All methyltestosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1128-2016All clobetasol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1129-2016All hydroquinone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1130-2016All Nitro Paste (nitroglycerin) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1131-2016All tacrolimus Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry..Class II
D-1132-2016All e2-e3-p4 Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1133-2016All diethylstilbestrol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1134-2016All baclofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1135-2016All potassium bromide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.Class II
D-1136-2016All Malarone (atovaquone and proguanil) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.; All lots compounded between 03/24/2015 and 03/24/2016 and within expiry..Class II
Based on the official FDA remedy

What to do — step by step

  1. Contact the pharmacy

    Reach out to Reliable Rexall-A Compounding Pharmacy in San Francisco for further instructions on how to handle your specific prescription.

Where it went and when

Where it was distributed

Distributed in 3 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: yesNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: yesHITexas: not listedTXFlorida: not listedFL

FDA distribution: “U.S. Including: CA, HI, NM” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Hawaii, New Mexico.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

1. Firm started the recall: Mar 25, 201612. FDA classified it Class II: Jul 6, 201623. Published in FDA’s Enforcement Report: Jul 13, 201634. FDA terminated the recall: Apr 10, 2017420162017
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-1135-2016 (March 25, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1135-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA