CLASS III Drug recall · Reported 30 May 2018 · FDA Enforcement Report
Zoma Shampoo, Zinc Pyrithione recalled by Milbar Laboratories
Milbar Laboratories is recalling Zoma Shampoo, Zinc Pyrithione 1.92%/, Dermatologic Cosmetic Laboratories, East Haven, CT, distributed nationwide in the US. The recall was initiated on 4 May 2018 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-0833-2018
- FDA event ID
- 80045
- Recalling firm
- Milbar Laboratories, East Haven, CT
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 May 2018
- FDA classified
- 22 May 2018
- Reported
- 30 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Sunscreen & Personal Care
Timeline
| 4 May 2018 | Recall initiated by company | |
| 22 May 2018 | Classified by FDA | +18 days |
| 30 May 2018 | 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
Subpotent
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
Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
Where it was distributed
Product was distributed to physicians and internet sales throughout the United States and Hong Kong, Panama, UK, China, Jordan, Qatar, Kuwait, and Central America.
Questions about this recall
Why was it recalled?
Subpotent
Which lots are affected?
Lot # HT659-6, expiration date 08/11/2019 LT168-7, expiration date 11/10/2019
Where was it sold?
Product was distributed to physicians and internet sales throughout the United States and Hong Kong, Panama, UK, China, Jordan, Qatar, Kuwait, and Central America.
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.
Other products in this recall event
1 other product · FDA event 80045This product is part of a recall event; the main page for the event is T Shampoo For Hair and Body, Solution Coal Tar recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | T Shampoo For Hair and Body, Solution Coal Tar recalled | Milbar Laboratories | Potency & Assay | Nationwide |
More recalls from Milbar Laboratories
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | (Malin+Goetz) spf 30 face moisturizer (Avobenzone recalled | Milbar Laboratories | Processing Deviation | Nationwide |
| Drug | CLASS II | (Malin + Goetz) Salicylic Gel (2% Salicylic Acid) tube recalled | Milbar Laboratories | Processing Deviation | Nationwide |
| Drug | CLASS II | DCL SA Scalp Therapy Shampoo recalled by Milbar Laboratories | Milbar Laboratories | Processing Deviation | Nationwide |
| Drug | CLASS II | DCL Active Mattifying Cleanser recalled by Milbar Laboratories | Milbar Laboratories | Processing Deviation | Nationwide |
| Drug | CLASS II | MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) recalled | Milbar Laboratories | Processing Deviation | Nationwide |