CLASS II Drug recall · Reported 12 Nov 2014 · FDA Enforcement Report
Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg recalled
Pharmaceutical Associates is recalling Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg, distributed nationwide in the US. The recall was initiated on 16 Oct 2014 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-0240-2015
- FDA event ID
- 69547
- Recalling firm
- Pharmaceutical Associates, Greenville, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Oct 2014
- FDA classified
- 6 Nov 2014
- Reported
- 12 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 16 Oct 2014 | Recall initiated by company | |
| 6 Nov 2014 | Classified by FDA | +21 days |
| 12 Nov 2014 | 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
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
Which lots are affected?
Lot 3H43, Exp. 02/15
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.
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|---|---|---|---|---|---|
| Drug | CLASS II | Nystatin Oral Suspension, USP per mL Cherry/Peppermint Flavor recalledNystatin | Pharmaceutical Associates | Potency & Assay | Nationwide |
| Drug | CLASS III | Nystatin Oral Suspension, USP, For Institutional Use Only recalledNystatin | Pharmaceutical Associates | Potency & Assay | Nationwide |