PlainRecalls

Search Recalls

Search our full database of product recalls from FDA, CPSC, NHTSA, and USDA. Find recalls by product name, brand, manufacturer, hazard type, or keyword.

PlainRecalls indexes tens of thousands of recall records across multiple federal agencies. Use the search box below to find specific products or browse by agency, category, or date on the respective listing pages. Search results include the recall title, the recalling firm, severity classification, and the date the recall was announced.

Found 21 recalls matching "promethazine"

FDA Drug Moderate Jun 7, 2023

Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031…

Akorn, Inc.

FDA Drug Moderate Jun 7, 2023

Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn, Inc.

FDA Drug Moderate Jun 15, 2022

Promethazine HCl Tablets, USP, 25 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6461-61

Mckesson Medical-Surgical Inc. Corporate Office

FDA Drug Moderate Feb 2, 2022

Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 Hercules Dr.…

Edge Pharma, LLC

FDA Drug Moderate Sep 29, 2021

Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactu…

Morton Grove Pharmaceuticals, Inc.

FDA Drug Moderate Sep 29, 2021

Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsi…

Morton Grove Pharmaceuticals, Inc.

FDA Drug Moderate Jun 2, 2021

PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16

Cardinal Health Inc.

FDA Drug Low Oct 16, 2019

Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10

Amneal Pharmaceuticals, Inc.

FDA Drug Low Jul 31, 2019

Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)

Amneal Pharmaceuticals, Inc.

FDA Drug Moderate Feb 6, 2019

Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00002…

Duren Health Mart Pharmacy

FDA Drug Moderate Jul 20, 2016

Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx, Only, Compounded by PHARMAKON Pharmaceuticals, Noblesvil…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesvil…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate May 20, 2015

Promethazine 25 mg/0.5 mLGel, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155

Health Innovations Pharmacy, Inc

FDA Drug Low Apr 15, 2015

PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 m…

Qualitest Pharmaceuticals

FDA Drug Moderate Mar 18, 2015

PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS: Promethazine H…

Qualitest Pharmaceuticals

FDA Drug Moderate May 28, 2014

PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus…

Zydus Pharmaceuticals USA Inc

FDA Drug Moderate Jan 22, 2014

PROMETHAZINE HCL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162052110

Aidapak Services, LLC

FDA Drug Moderate Jan 22, 2014

CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS Tablet, 120 units/105 mg/81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64980015001

Aidapak Services, LLC

FDA Drug Low Oct 17, 2012

Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufact…

Actavis Mid Atlantic LLC

FDA Drug Low Oct 17, 2012

Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride 5m…

Actavis Mid Atlantic LLC

How PlainRecalls Search Works

The search tool on this page lets you query the full PlainRecalls dataset by name, location, identifier, or any supported field. We index every record at ingestion time so typical queries return in well under a second, even on large result sets. Matching is tolerant of partial input and common misspellings — you can type a last name, a city, a bar or license number, or any fragment of a record title. If you get no results, try broadening the query or using a shorter prefix.

What Happens Behind the Search Box

Every search queries our read-only mirror of the upstream public-record dataset. We refresh the mirror on a scheduled cadence — check the methodology page for the current source freshness window — and we do not modify the underlying records, only normalize formatting (title case, trimmed whitespace, standardized state codes) so that search results are consistent across records with different upstream spellings. Results link directly to the full record page, where you will see the complete regulated data plus plain-language explainers that describe what each field means.

Responsible Use of Search Results

Information surfaced here is drawn from public sources, but individual records can contain clerical errors, may lag real-world changes, or may be incomplete for historical reasons. Before making any consequential decision — legal, medical, financial, employment, safety-related — you should verify the underlying fact directly with the issuing agency. PlainRecalls does not render professional advice, does not rank or endorse individual records, and does not accept paid placement. We surface public data faithfully and explain it in clear language; how you act on the information is your responsibility and, when the stakes are high, the responsibility of a licensed professional you consult.

Search Privacy

Your search queries are processed server-side and are not attached to any account. We log aggregate query patterns (term frequencies, not individual queries tied to a person) for the sole purpose of improving the search index and flagging records where visitors expect more detail. We never sell, share, or resell search logs. If you would like your query logs disregarded entirely, enable private browsing or a tracker-blocker — we respect these settings.