Product Quest Manufacturing LLC

Product Quest Manufacturing LLC: 54 FDA recall reports

Every drug recall the FDA has published for Product Quest Manufacturing LLC. The fault, and how the agency graded it.

54Reports
1Class I
0Ongoing
2018-10-24Most recent
1 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II51
Class III2
Class I1
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slippery Elm, 1.5 FL OZ (44 mL) bottle,

D-0053-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slippery Elm, 1.5 FL OZ (44 mL) bottle, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00660 4.
Where it went
Nationwide in the USA
How much
22,392 bottles

Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-

D-0048-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-00 UPC 8 40986 01483 3; b) 1.5 FL OZ (44 mL) bottle NDC 68016-466-00 UPC 8 40986 01482 6, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431.
Where it went
Nationwide in the USA
How much
102,348 bottles

QC Quality Choice, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14.1 g) tube, Distributed by C.D.M.A., Inc., 4

D-0049-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
QC Quality Choice, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14.1 g) tube, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, UPC 6 35515 99202 3.
Where it went
Nationwide in the USA
How much
4,200 tubes

Best Choice, 12 Hour Extra Moisturizing, Nasal Spray (Oxymetazoline Hydrochloride 0.05%), Nasal Decongestant,

D-0056-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
Best Choice, 12 Hour Extra Moisturizing, Nasal Spray (Oxymetazoline Hydrochloride 0.05%), Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave., Kansas City, KS 66106, UPC 0 70038 59328 7.
Where it went
Nationwide in the USA
How much
2,112 bottles

Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tu

D-0069-2019  ·  Class III  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Product
Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, UPC 3 11917 18281 0.
Where it went
Nationwide in the USA
How much
6,516 tubes

Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48

D-0078-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48 pk. (12687901)
Where it went
Nationwide in the USA
How much
Unknown

Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, I

D-0079-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, Inc., Miami, FL 33166.
Where it went
Nationwide in the USA
How much
Unknown

TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed By Topco Associates LLC, Elk Gro

D-0054-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed By Topco Associates LLC, Elk Grove Village, IL 60007, UPC 0 36800 42146 2.
Where it went
Nationwide in the USA
How much
7,488 tubes

CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%, packaged in a) Net Wt.

D-0030-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%, packaged in a) Net Wt. 1.52 OZ (43 g) can UPC 0 50428 37079 7 Product #896831; b) Net Wt. 4.25 OZ (120 g) can UPC 0 50428 36124 5; c) Children's Net Wt. 2 OZ (57 g) can UPC 0 50428 58685 3 Product #282472, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.
Where it went
Nationwide in the USA
How much
529,536 cans

Family Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562.

D-0080-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
Family Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562.
Where it went
Nationwide in the USA
How much
Unknown

Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) t

D-0070-2019  ·  Class III  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Product
Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) tube, Distributed by: Genomma Lab USA Inc., Houston, TX 77027, UPC 6 50067 00018 7.
Where it went
Nationwide in the USA
How much
7,944 tubes
Class I

Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Phar

D-0074-2019  ·  Class I  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
Product
Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 43236 5.
Where it went
Nationwide in the USA
How much
16 bottles

Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g) tube, Distributed by Mushatts, L

D-0072-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicylic acid.
Product
Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g) tube, Distributed by Mushatts, LLC, P.O. Box 372476, Satellite Beach, FL 32937, UPC 8 58245 00203 3.
Where it went
Nationwide in the USA
How much
1,440 tubes

QC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chloride 0.65%, packaged as a) 1.5 FL

D-0050-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
QC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chloride 0.65%, packaged as a) 1.5 FL OZ (45 mL) bottle UPC 6 35515 98845 3; b) 3 FL OZ (89 mL) bottle UPC 6 35515 95042 9, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995.
Where it went
Nationwide in the USA
How much
172,800 bottles

Harmon Face Values, Saline Nasal Spray (sodium chloride), 0.65%, packaged as a) 1.5 FL OZ (44 mL) bottle UPC 7

D-0040-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
Harmon Face Values, Saline Nasal Spray (sodium chloride), 0.65%, packaged as a) 1.5 FL OZ (44 mL) bottle UPC 7 27510 00501 0; b) 3 FL OZ (88 mL) bottle UPC 7 27510 00502 7, Distributed by Harmon Stores, Inc., Union, NJ 07083 USA.
Where it went
Nationwide in the USA
How much
39,924 bottles

meijer, Saline Nasal Spray, Nasal Moisturizing Spray, packaged as a) 1.5 FL OZ (44 mL) UPC 7 08820 74428 8; b)

D-0041-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
meijer, Saline Nasal Spray, Nasal Moisturizing Spray, packaged as a) 1.5 FL OZ (44 mL) UPC 7 08820 74428 8; b) 3FL OZ (88 mL) UPC 7 08820 74430 1, Dist. By Meijer Distribution, Inc., Grand Rapids, MI 49544 .
Where it went
Nationwide in the USA
How much
182,568 bottles

Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength,

D-0064-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour + Menthol, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7001-01, UPC 3 11917 18536 1.
Where it went
Nationwide in the USA
How much
533,016 bottles

CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%, 4.25 OZ (126 g) can, Dis

D-0032-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%, 4.25 OZ (126 g) can, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 41854 3.
Where it went
Nationwide in the USA
How much
277,587 cans

FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium Chloride Solution), 4.25 FL OZ (

D-0038-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium Chloride Solution), 4.25 FL OZ (126 mL) can, Distributed by: Midwood Brands, LLC, 10611 Monroe Rd., Matthews, NC 28105, UPC 0 32251 11617 9.
Where it went
Nationwide in the USA
How much
46,056 cans

Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/

D-0077-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/3/1 #12687901 w/ Silo
Where it went
Nationwide in the USA
How much
Unknown

Meijer, Sterile Saline Nasal Mist (0.9% Sodium Chloride Solution), 4.25 OZ (120 g) can, Dist. By Meijer Distri

D-0042-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
Meijer, Sterile Saline Nasal Mist (0.9% Sodium Chloride Solution), 4.25 OZ (120 g) can, Dist. By Meijer Distribution, Inc., 2929 Walker Ave. NW, Grand Rapids, MI 49544, UPC 7 13733 27615 3.
Where it went
Nationwide in the USA
How much
37,464 cans

CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray, Contains: Sodium Chloride 0.65%, Benzyl Alcohol & Be

D-0031-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray, Contains: Sodium Chloride 0.65%, Benzyl Alcohol & Benzalkonium Chloride as Preservatives, 1.5 FL OZ (44 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 40814 8 Product #891465.
Where it went
Nationwide in the USA
How much
552 bottles

Rhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl Oz. (40 ml), Manufactured for: Sch

D-0075-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
Rhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl Oz. (40 ml), Manufactured for: Scherer Laboratories, Inc., Atlanta, GA 30339.
Where it went
Nationwide in the USA
How much
Unknown

Premier Value, Fast Relief, Muscle Rub, (menthol 10% and methyl salicylate 15%) 4 OZ (113 g) tube, Distributed

D-0068-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
Superpotent Drug: high out of specification assay results for the menthol ingredient.
Product
Premier Value, Fast Relief, Muscle Rub, (menthol 10% and methyl salicylate 15%) 4 OZ (113 g) tube, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd., Suite 101, Boca Raton, FL, 33431, UPC 8 40986 01341
Where it went
Nationwide in the USA
How much
4,692 tubes

OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9; b) 45 cc (1.5 fl. oz

D-0055-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9; b) 45 cc (1.5 fl. oz.) UPC 3 01875 26003 3, c) Buddy Pack containing one 1.5 FL. OZ. (44 mL) and one 0.76 FL.OZ. (22 mL) bottle per carton, Distributed by: Valeant Consumer Products, A Division of Valeant Pharmaceuticals, North America LLC, Bridgewater, NJ 08807.
Where it went
Nationwide in the USA
How much
3,442,536 bottles

CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby Net Wt. 0.5 OZ (14.2 g) tube UPC 0 50428

D-0034-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby Net Wt. 0.5 OZ (14.2 g) tube UPC 0 50428 58392 0 Product #282476; and b) Net Wt. 0.5 OZ tube (14.2 g) UPC 0 50428 31746 4 Product #896071; Distributed by CVS Pharmacy, Inc,. One CVS Drive, Woonsocket, RI 02895.
Where it went
Nationwide in the USA
How much
285,840 tubes

CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate 5%, octocrylene 10%,

D-0071-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
Product
CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate 5%, octocrylene 10%, Net Wt. 0.15 oz. (4.25 g) stick, CeraVe LLC., New York, NY 10001, UPC 3 01872 49201 7.
Where it went
Nationwide in the USA
How much
25,596 sticks

DG health, No Drip, Nasal Pump Mist (oxymetazoline hydrochloride), 0.05%, 1 FL OZ (30 mL) bottle, Distributed

D-0037-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
DG health, No Drip, Nasal Pump Mist (oxymetazoline hydrochloride), 0.05%, 1 FL OZ (30 mL) bottle, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072, UPC 7 27510 00373 3 .
Where it went
Nationwide in the USA
How much
786,720 bottles

HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer Labs International, LLC. 330 Carswe

D-0043-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer Labs International, LLC. 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02742 68045 9 .
Where it went
Nationwide in the USA
How much
3264 bottles

Premier Value, Nasal Decongestant, Nasal Spray (oxymetazoline HCl 0.05%), Regular Strength, 1 FL OZ (30 mL) bo

D-0047-2019  ·  Class II  ·  reported 2018-10-24  ·  Terminated

Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product
Premier Value, Nasal Decongestant, Nasal Spray (oxymetazoline HCl 0.05%), Regular Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-316-03, UPC 8 40986 01516 8.
Where it went
Nationwide in the USA
How much
4992 bottles

Showing the 30 most recent of 54. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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