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Unrated Drug recall · FDA · Published November 18, 2016

Kids' Relief Ear Recall: CGMP Deviations in Oral Liquid

Raritan Pharmaceuticals recalls Kids' Relief Ear Relief Oral Liquid due to CGMP deviations. Check lot #35254.

🇺🇸 FDA recall #D-0233-2017DrugKids' Relief ›
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Recalling firmRaritan Pharmaceuticals, Inc.8 Joanna Ct · East Brunswick, NJ 08816-2108
✎ GovInfoNow plain-language explainer

What happened, in plain English

Raritan Pharmaceuticals, Inc. is recalling Kids' Relief Ear Relief Oral Liquid because of Current Good Manufacturing Practice (CGMP) deviations. The recall affects 22,704 bottles distributed in New York. No specific injury mechanism or remedy is listed in the record. Read more at govinfonow.com/recall/42167-kids-relief-ear-recall-cgmp-deviations-in-oral-liquid.

Source Summary by GovInfoNow · govinfonow.com/recall/42167-kids-relief-ear-recall-cgmp-deviations-in-oral-liquid · Updated October 11, 2026 · FDA enforcement record: FDA #D-0233-2017

Cite this page

“Kids' Relief Ear Recall: CGMP Deviations in Oral Liquid.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/42167-kids-relief-ear-recall-cgmp-deviations-in-oral-liquid. Based on FDA recall #D-0233-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0233-2017%22&limit=1).

Why it’s dangerous

The record cites CGMP deviations, which means the product was not manufactured according to federal quality standards. The specific nature of these deviations and how they affect safety or efficacy is not described in the provided text.

Who’s affected

Parents or caregivers in New York who purchased Kids' Relief Ear Relief Oral Liquid between the manufacturing date and May 2020 may have this product.

How to tell if you have this one

Look for Kids' Relief Ear Relief Oral Liquid in 0.85 fl oz (25 mL) bottles. Check for NDC 60512-913-8, UPC 77815909639, Lot # 35254, and an expiration date of 05/20.

  • Brand
    Kids' Relief
  • Product
    Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption Blvd. Montreal, QC H1N 2H2 Canada NDC
  • Category
    Drug
FDA recall event · 3 products

All 3 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.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    NY
Recall numberProduct, codes & lotsQuantity
D-0232-2017CVS Health Homeopathic Infants Teething Tablets 135 count bottle Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 NDC 59779-860-03 UPC 0504284162; Lot #: 41116, 43436; Exp. 03/2045,648 bottles
D-0233-2017Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption Blvd. Montreal, QC H1N 2H2 Canada NDC 60512-913-8 UPC 77815909639; Lot # 35254; Exp. 05/2022,704 bottles
D-0234-2017CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz (25 mL) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket RI 02895 NDC 59779-687-02 UPC 77815909639; Lot # 33149; Exp. 01/2020,448 bottles

Where it went and when

Where it was distributed

Distributed in New York.

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: yesNYRhode 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: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: 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: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “NY” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: New York.

Recall timeline

FDA terminated this recall 3.1 years after the firm started it.

1. Firm started the recall: Nov 18, 201612. FDA classified it Class II: Dec 23, 201623. Published in FDA’s Enforcement Report: Jan 4, 201734. FDA terminated the recall: Jan 8, 2020420162020
  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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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-0233-2017 (November 18, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0233-2017 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