CLASS II Drug recall · Reported 15 Feb 2023 · FDA Enforcement Report
Posaconazole Delayed-Release Tablets, 100 mg recalled by Biocon Pharma
Biocon Pharma is recalling Posaconazole Delayed-Release Tablets, 100 mg, distributed nationwide in the US. The recall was initiated on 31 Jan 2023 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-0268-2023
- FDA event ID
- 91577
- Recalling firm
- Biocon Pharma, ISELIN, NJ
- Brand
- Posaconazole
- Manufacturer
- Biocon Phama Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Jan 2023
- FDA classified
- 14 Feb 2023
- Reported
- 15 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
Timeline
| 31 Jan 2023 | Recall initiated by company | |
| 14 Feb 2023 | Classified by FDA | +14 days |
| 15 Feb 2023 | Published in enforcement report | +1 day |
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: High Out Of Specification degradation results.
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
Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Which lots are affected?
Lot #: BF21003163, BF21003246, BF21003161, Exp. Sep-2023; BF21004742, Exp. Dec-2023; BF22003359, Exp. Sep-2025
Where was it sold?
Nationwide in the USA
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 Biocon Pharma
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Atorvastatin Calcium Tablets USP 40 mg recalled by Biocon PharmaAtorvastatin Calcium | Biocon Pharma | Potency & Assay | Nationwide |
Other Posaconazole recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Noxafil Powdermix (posaconazole) recalled by Merck Sharp & DohmeNoxafil | Merck Sharp & Dohme | Particulate Matter | Nationwide |