Qualitest Recalls Promethazine DM Syrup Due to Plastic Particulates
Qualitest Pharmaceuticals is recalling 972 bottles of Promethazine DM Syrup because plastic cap closure particulates may be present in the product.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves the presence of foreign substance (plastic particulates) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Qualitest Pharmaceuticals is recalling 972 bottles of Promethazine DM Syrup, NDC 0603-1586-58. The affected product is Lot # 0000001099 with an expiration date of 03/16. The recall was initiated because plastic cap closure particulates may be present in the product.
The recalled product was distributed nationwide. Each 5 ml (one teaspoonful) of the syrup contains Promethazine Hydrochloride 6.25 mg, Dextromethorphan Hydrobromide 15 mg, and 7% alcohol. The product is available by prescription only.
Consumers with this product should contact their healthcare provider or pharmacist for instructions on how to proceed. The recall is classified as Class II by the FDA.
The recalled product
- Product
- PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS: Promethazine Hydrochloride 6.25 mg, Dextromethorphan Hydrobromide 15 mg, alcohol 7%, ONE PINT (574 mL), Rx only, Manufactured for: QUALITEST…
- Manufacturer
- Qualitest Pharmaceuticals
- Category
- Drug — Prescription Syrup
- Hazard
- Affected units
- 972
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 0000001099
- Exp. 03/16
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Qualitest Pharmaceuticals
See all →- LowQualitest Recalls Allopurinol Tablets Due to Oversized and Discolored Appearance
FDA (Drugs) · 2015-09-09
- LowQualitest Recalls HydrOXYzine Tablets Due to Unreadable Identification Codes
FDA (Drugs) · 2015-07-22
- ModerateQualitest Recalls Disulfiram Tablets Due to Dissolution Failure
FDA (Drugs) · 2015-07-08
- LowQualitest Recalls Promethazine VC With Codeine Syrup Due to Impurity
FDA (Drugs) · 2015-04-15
- ModerateQualitest Recalls Amlodipine Besylate Tablets Due to Oversized Size
FDA (Drugs) · 2015-03-11
Same hazard · foreign substance
See all →- ModerateHeritage Pharmaceuticals Recalls Clindamycin Palmitate Hydrochloride Due to Foreign Particles
FDA (Drugs) · 2026-08-19
- HighPrednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
FDA (Drugs) · 2026-07-08
- ModerateCorlanor Ivabradine Tablets Recalled for Foreign Substance Contamination
FDA (Drugs) · 2026-07-01
- LowHydroxyzine Hydrochloride Oral Solution recalled for foreign substance
FDA (Drugs) · 2026-07-01
- ModerateCorlanor ivabradine tablets recalled for presence of foreign substance
FDA (Drugs) · 2026-07-01
Similar recalls
- LowQualitest Recalls Promethazine VC With Codeine Syrup Due to Impurity
FDA (Drugs) · 2015-04-15
- LowQualitest Recalls Cetirizine Hydrochloride Syrup Due to Impurity Failure
FDA (Drugs) · 2014-01-08
- ModerateQualitest Recalls Hydrochlorothiazide Capsules Due to Particulate Matter
FDA (Drugs) · 2015-11-25
- ModeratePromethazine Syrup Plain Recall Due to Microbial Contamination
FDA (Drugs) · 2021-09-29
- LowQualitest Recalls Dexamethasone Elixir Due to Failed Impurity Specifications
FDA (Drugs) · 2017-02-01
- LowQualitest Recalls Temazepam Capsules Due to Failed Stability Specifications
FDA (Drugs) · 2017-01-11