CLASS II Drug recall · Reported 18 Mar 2015 · FDA Enforcement Report
Promethazine DM Syrup (Promethazine Hydrochloride recalled
Qualitest Pharmaceuticals is recalling Promethazine DM Syrup (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, distributed nationwide in the US. The recall was initiated on 23 Feb 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0411-2015
- FDA event ID
- 70598
- Recalling firm
- Qualitest Pharmaceuticals, Huntsville, AL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Feb 2015
- FDA classified
- 12 Mar 2015
- Reported
- 18 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Cold & Cough Medicine
Timeline
| 23 Feb 2015 | Recall initiated by company | |
| 12 Mar 2015 | Classified by FDA | +17 days |
| 18 Mar 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Product as listed by the FDA
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 PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-1586-58.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Which lots are affected?
Lot #: 0000001099; Exp. 03/16
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Qualitest Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS III | Allopurinol Tablets, USP, 300 mg recalled by Qualitest PharmaceuticalsAllopurinol | Qualitest Pharmaceuticals | Other | Nationwide |
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| Drug | CLASS III | Disulfiram tablets, USP, 500 mg recalled by Qualitest Pharmaceuticals | Qualitest Pharmaceuticals | Potency & Assay | Nationwide |
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| Drug | CLASS II | Amlodipine Besylate Tablets USP, 10 mg* bottles recalled | Qualitest Pharmaceuticals | Other | Nationwide |