CLASS II Drug recall · Reported 16 Feb 2022 · FDA Enforcement Report
APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container recalled
ULTRAtab Laboratories is recalling APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc. The recall was initiated on 26 Jan 2022 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-0529-2022
- FDA event ID
- 89334
- Recalling firm
- ULTRAtab Laboratories, Highland, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jan 2022
- FDA classified
- 9 Feb 2022
- Reported
- 16 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Cold & Cough Medicine
Timeline
| 26 Jan 2022 | Recall initiated by company | |
| 9 Feb 2022 | Classified by FDA | +14 days |
| 16 Feb 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00
Where it was distributed
Bulk product was distributed to 3 distributors who may have distributed finished product.
Questions about this recall
Is APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc recalled?
Yes. ULTRAtab Laboratories recalled APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc on 26 Jan 2022. The recall is Class II and its status is Terminated. Recall number D-0529-2022.
Why was it recalled?
CGMP Deviations
Which lots are affected?
Product Codes: C135LA Bulk Lots: 19F077
Where was it sold?
Bulk product was distributed to 3 distributors who may have distributed finished product.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.