CLASS III Drug recall · Reported 21 Aug 2013 · FDA Enforcement Report
Clobetasol Propionate Cream recalled by Hi-Tech Pharmacal Co
Hi-Tech Pharmacal is recalling Clobetasol Propionate Cream, USP, 0.05%, distributed nationwide in the US. The recall was initiated on 25 Jul 2013 and the FDA has classified it as Class III.
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-888-2013
- FDA event ID
- 65803
- Recalling firm
- Hi-Tech Pharmacal, Amityville, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Jul 2013
- FDA classified
- 13 Aug 2013
- Reported
- 21 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Creams, Ointments & Gels
Timeline
| 25 Jul 2013 | Recall initiated by company | |
| 13 Aug 2013 | Classified by FDA | +19 days |
| 21 Aug 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is packaged into tubes and then placed into unit cartons.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP
Which lots are affected?
Batch/Lot 619442, exp. 01/2015
Where was it sold?
Nationwide and Puerto Rico
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Hi-Tech Pharmacal
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|---|---|---|---|---|---|
| Food | CLASS III | Rx Choice Liquid Vitamin C recalled by Hi-Tech Pharmacal Co | Hi-Tech Pharmacal | Other | 13 states |
| Food | CLASS III | Rx Choice Liquid Vitamin C recalled by Hi-Tech Pharmacal Co | Hi-Tech Pharmacal | Other | 16 states |
| Food | CLASS II | Ferrous Sulfate Elixir 220 mg recalled by Hi-Tech Pharmacal CoFerrous Sulfate | Hi-Tech Pharmacal | Potency & Assay | 5 states |
| Drug | CLASS II | HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg recalled | Hi-Tech Pharmacal | Potency & Assay | Nationwide |
| Drug | CLASS III | Acyclovir Oral Suspension, USP 200 mg recalled by Hi-Tech Pharmacal Co | Hi-Tech Pharmacal | Potency & Assay | Nationwide |
Other Clobetasol Propionate recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Clobetasol Propionate Ointment, USP, 0.05% tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Clobetasol Propionate Cream recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Clobetasol propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Clobetasol Propionate Lotion 0.05%, Generic for Temovate recalled | Preferred Pharmaceuticals | Potency & Assay | IL |